Efficacy of Dashmool Vasti as an adjuvant therapy with the standard of care (modern + physiotherapy) in the rehabilitation of stroke as compared to standard of care – a clinical trial protocol

Punam Sawarkar; Vaishali Kuchewar; Gaurav Sawarkar; Irshad Qureshi

doi:10.12688/f1000research.141553.1

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Study Protocol

Efficacy of Dashmool Vasti as an adjuvant therapy with the standard of care (modern + physiotherapy) in the rehabilitation of stroke as compared to standard of care – a clinical trial protocol

[version 1; peer review: 1 approved with reservations]

Punam Sawarkar ¹, Vaishali Kuchewar¹, Gaurav Sawarkar¹, Irshad Qureshi²

PUBLISHED 14 Dec 2023

Author details Author details

¹ Mahatma Gandhi Ayurved College Hospital and Research Centre, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India
² Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India

Punam Sawarkar
Roles: Conceptualization, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Vaishali Kuchewar
Roles: Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Gaurav Sawarkar
Roles: Conceptualization, Writing – Original Draft Preparation, Writing – Review & Editing

Irshad Qureshi
Roles: Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background

Stroke is ischemia and neurological dysfunction caused by acute brain circulation loss. It causes acute localized neurological abnormalities such as weakness, sensory deficit, or language issues that require long-term treatment. These deficiencies harm the patient and their family psychologically, socially, and economically. Thus, combination treatment can rapidly rehabilitate such patients. Detoxification methods like Ayurvedic medicated enema help stroke pathophysiology. Physical modalities in physiotherapy have been shown to facilitate normal movement and function on the stroke patient’s affected side, increasing independence with everyday duties. A stroke patient may benefit from Dashmoola Niruha Vasti, Function Electrical Stimulation (FES), and Motor Relearning Programme (MRP).

Aim & Objectives

This study compares the adjuvant role of Dashmoola Vasti with MRP and FES in stroke recovery. The main goals of this study are to assess and compare the adjuvant role of Dashmoola Vasti with standard control over sensorimotor function of lower extremities; static & dynamic balance in stroke patients; gait parameters; resistance experienced during passive range of motion; quality of life of patients; Barthel Index; Modified Ashworth Scale; and Fuglmeyer assessment, Single Limb Stance Test, Functional Reach Test.

Methods

A total of 40 patients will be enrolled and divided randomly into two equal groups. In Group A (control), standard treatment (modern + physiotherapy) will be prescribed for one month. In Group B (interventional group), Dashmoola Vasti will be added to the afore-said standard treatment for one month.

Expected results

Improvement in Fuglmeyer assessment, Single Limb Stance Test, Functional reach test, quality of life of patients, Barthel Index, Modified Ashworth scale and National Institute of Health (NIH) stroke-scale-score, will be observed and recorded.

Conclusions

Results and conclusions will be derived according to the data collected in case record form and assessment sheets filled at baseline and follow-up visits.

Trial registration

CTRI/2021/10/037445 dated 21.10.2021.

Keywords

Stroke, Pakshaghata, Panchkarama, Niruha Vasti, Dashmoola, Adjuvant, Physiotherapy, MRP, FES

Corresponding author: Punam Sawarkar

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2023 Sawarkar P et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Sawarkar P, Kuchewar V, Sawarkar G and Qureshi I. Efficacy of Dashmool Vasti as an adjuvant therapy with the standard of care (modern + physiotherapy) in the rehabilitation of stroke as compared to standard of care – a clinical trial protocol [version 1; peer review: 1 approved with reservations]. F1000Research 2023, 12:1589 (https://doi.org/10.12688/f1000research.141553.1) First published: 14 Dec 2023, 12:1589 (https://doi.org/10.12688/f1000research.141553.1) Latest published: 10 Apr 2024, 12:1589 (https://doi.org/10.12688/f1000research.141553.3)

Introduction

In clinical practice, stroke has been very notorious for impeding the continuity of life and day-to-day activities. It is the most common example of such a crippling disorder. On extensive review of contemporary literature, it is observed that, despite massive worldwide efforts in this science to rectify early results in reducing the risk of death or disability, it is disappointing.¹ Partial recovery is obtained after a particularly long time. Moreover, it is observed that there are certain limitations, contra-indications, or side effects of currently established treatment modalities for stroke.²

Considering the complicated and critical nature of the disease, i.e., stroke, it becomes imperative to search for safe, promising and effective treatment modalities in alternative sciences for early rehabilitation purposes for stroke. Though most of the studies suggest that the individual use of Panchakarma therapy, especially external oleation (Bahya Snehana), sudation therapy (Swedana) along with medicated enema (Vasti) and conventional physiotherapy, i.e., Motor Relearning Programme (MRP), and the combination of electrical modality with Functional Electrical Stimulation (FES) shows promising results in the rehabilitation of patients with stroke.

However, no study has been carried out to assess their combined effects on the therapeutic outcome of the rehabilitation of such patients. Moreover, the research is also required to determine the MRP and FES combined effect of supporting stroke patients for improving knee extension and gait parameters. Therefore, this study is proposed to generate clinical evidence showing excellent post-stroke recovery within a short time in restoring gross and fine movements to the maximum extent in a quicker manner.

The study’s goal is to analyze and compare the adjuvant role of Dashmoola Vasti with standard treatment in stroke rehabilitation. In addition, the efficacy of physiotherapy (MRP and FES) in the rehabilitation of stroke patients will be assessed. The study’s goal is to assess and compare the adjuvant role of Dashmoola Vasti with standard control over sensorimotor function of lower extremities in stroke patients using the Fugl-Meyer assessment, as well as to assess and compare the adjuvant role of Dashmoola Vasti with standard control over static and dynamic balance in stroke patients using the Single Limb Stance Test and Functional Reach Test, respectively. The secondary goal is to evaluate and compare the adjuvant role of Dashmoola Vasti with standard control over gait parameters (distance and time parameters), the Barthel Index, resistance experienced during passive range of motion based on the modified Ashworth scale, and the National Institute of Health (NIH) stroke-scale-score in stroke patients.

Methods

Ethical considerations

IEC clearance is taken from the Institutional Ethical Committee, Datta Meghe Institute of Higher Education and Research (DMIHER), Wardha. IEC certificate obtained: Ref No. DMIHER (DU)/IEC/2021/279 dated 15.04.2021. The project has been registered with Clinical Trials Registry India (CTRI) (registration number CTRI/2021/10/037445) dated 21.10.2021).

Written informed consent will be taken from the patient before starting the study. During the study, the confidentiality of each patient will be maintained.

Study design

It is an interventional study, it is a superiority clinical trial, i.e., randomized reference standard control open-labeled two-arm comparative clinical trial.

Sample size

Due to practical considerations such as cost, patient inconvenience, judgments not to proceed with an investigation or a lengthy study duration, the number of participants in the study is restricted. So for the phase-I trial, 20 sample size is considered for each group.³

Recruitment

Daily visit to the stroke inpatient ward is planned at Acharya Vinoba Bhave Rural Hospital, and if the patient is willing to enroll in the said study can be recruited for the study after written informed consent. Patients will be added one at a time until the target sample size is reached.

Setting

Locus of the study: out patient department and inpatient department of Panchakarma & Kayachikitsa department, Mahatma Gandhi Ayurveda College Hospital and Research Centre (MGACH&RC), Salod (Hirapur) Wardha, Maharashtra. & Department of Neuro physiotherapy, Ravi Nair Physiotherapy College, Sawangi, Wardha Maharashtra, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra.

Study setting: The study will be conducted in Panchakarma OPD & IPD, Mahatma Gandhi Ayurveda College Hospital and Research Centre (MGACH&RC), Salod (Hirapur) Wardha, Maharashtra.

Patients will be recruited after approval from Clinical Trials Registry- India (CTRI), and the exposure period for treatment will be one month. The follow-up will be conducted on the 60^th and 90^th day of treatment.

Criteria for discontinuing or modifying: if patients are willing to quit in between they will be allowed to quit and will be replaced; if the patient develops an acute illness during the trial, which may hamper the study and withdrawn patients will be replaced.

Participants

Diagnosed cases of stroke will be enrolled in the study with the computerized randomization method.

Eligibility criteria

The inclusion criteria for the study are the patients with the first stroke diagnosed with CT/MRI (thrombolytic stroke only) without other neurological deficits but < six months of onset, patients diagnosed as stroke with ICD code 2020 ICD-10-CM Diagnosis Code I69.351 patients between 45 to 60 years of age irrespective of gender/occupation and socio-economic status. Patients with controlled hypertension and Noninsulin dependent Diabetes Mellitus (NIDDM). Patient with ankle dorsiflexors stage 1 to 2 and ankle plantar flexors spasticity 1+ on. Patients willing to give informed consent and ready to follow simple instructions.

The exclusion criteria for the study are the patients having thrombolytic stroke with onset for > than six months, subjects with complications such as uncontrolled metabolic disorders and severe systemic disorders, e.g., renal or cardiac failure, altered sensorium, or coma. Those who are on tube feeding or intravenous fluid therapy. The patients of stroke with a history of trauma (Abhighatajanya), onset due to intracranial space-occupying lesions, post-surgical or postpartum complication, degenerative disorders of the brain or intracranial infectious disease or hemorrhagic nature. The patients with specific medical and psychological contraindications for electrical stimulation Brooks,⁴ patients with visual or auditory difficulties, anti-anxiolytic treatments. Pregnant women and lactating mothers will also excludedbe. Patients contraindicated for Vasti & Swedana therapy and patients with fixed ankle or foot contracture, pacemaker, and a metal plate in the lower limb will be excluded.

Interventions

For group A, standard control modern treatment (Anti-thrombotic treatment, e.g. Tab. Ecosprin 75/150 mg OD and Tab. Notropril 800mg TDS) will be given along with physiotherapy. The physiotherapy sitting for motor relearning program and functional stimulation will be given for 55 mins per sitting, five days weekly for one month.

For group B, standard control modern treatment will be given along with Ayurveda Panchakarma and physiotherapy. In this case, gentle massage with Dashmoola Taila + Nadi Sweda with Dashmoola Qwath + medicated enema (alternate regime of Dashamoola Niruha Vasti with Anuvasana Vasti with Dashmoola Taila will be prescribed for the treatment. The alternative regime of medicated enema i.e., Anuvasana Vasti (oil enema) and Dashamoola Niruha Vasti (decoction enema) will be given on odd and even days respectively for one month, and physiotherapy for five days weekly for one month.

The methodology of the study is mentioned in Table 1 and the flowchart of the study design or methodology is given in Figure 1.

Table 1. Methodology of the study.

Group

Sample size

Intervention

Type of Treatment

Duration of treatment

Total duration

Follow-up

Standard Control

Modern + Physiotherapy (MRP+FES)

For Physiotherapy sitting (55 mins/sitting)

physiotherapy (Five days weekly for one month)

on 60^th & 90^th Day

Standard Control +Panchakarma

Modern + Physiotherapy (MRP+FES) Gentle massage with Dashmoola Taila + Nadi Sweda with Dashmoola Qwath + Medicated Enema (Alternate regime of Dashamoola Niruha Vasti with Anuvasana Vasti with Dashmoola Taila

• Same as group A+ Dashmoola Vasti Details of Dashmoola Vasti Are as follows:
• Local Snehana-10 mins
• Local Swedana-10 mins or till attainment of Samyak Swinna Lakshana, whichever is earlier.

• Panchakarma for complete one month (Day 1^st – Day 30^th)
• Physiotherapy for Five days weekly for one month

on 60^th & 90^th Day

* FES – Function Electrical Stimulation, MRP – Motor Relearning Programme.

Figure 1. Study design including grouping, intervention, assessment plan and follow-up.

*FES – Function Electrical Stimulation, MRP – Motor Relearning Programme, NIH – National Institutes of Health.

Assessment tools

The assessment criteria will be the Fugl-Meyer assessment, one-leg stance test, gait parameters (distance and time parameters), modified Ashworth scale, functional reach test, quality of life scale, Barthel index, NIH stroke scale score (NIHSS)⁵^,⁶

Variables to be measured

Improvements in the following assessment variables are expected as primary outcomes: Fugl-Meyer assessment for sensori-motor function of lower extremities, one-leg stance test, functional reach test for static and dynamic balance in patients, quality of life scale and Barthel index independent living of patients with Stroke, resistance experienced during passive range of motion based measured on Modified Ashworth scale NIHSS for improvements in clinical features of stroke are expected to be measured.⁷

Participant timeline

• For physiotherapy (five days weekly for one month)
• Karma Vasti (alternate regime of Niruha Vasti with Dashmoola Qwath and Anuvasana Vasti with Dashamoola oil for complete one month, i.e., Day 1^st–Day 30^th)

Time schedule of enrolment: Patients with the first Stroke diagnosed with CT/MRI (thrombolytic Stroke only) without other neurological deficits but <6 months of onset will be enrolled for the study.

Interventions (including any run-ins and washouts): There are no washout periods; the intervention of Panchakarma treatment and Physiotherapy sitting for 30 days.

Assessments and visits for participants: Assessment will be carried out at baseline level and after the intervention, i.e., on the 30^th day, then followup visits on the 60^th and 90^th day.

Assignment of interventions (for controlled trials)

Patients will be recruited by simple randomization through the computer-generated table. The principal investigator (PI) and co-investigator (CO-I) will allocate and enroll the patient.

Using computer-generated random numbers, the researcher creates random allocation cards. He will keep the original random allocation sequences in a secure third location and work with an alternate copy. A researcher will enroll the patients.

The envelopes will be marked with serial numbers on the outside. The date, time, patient ID, post-procedure results, and other required details will be on the envelope.

Data collection, management, and analysis methods

For retention of patients, appointment reminders will be scheduled, and question-answering sessions will be planned. The complete followup will be mentioned in the patient file, and if patients are required to withdraw or discontinue, the patient file will be closed and maintained for the record purposes.

Observations will be made after the completion of the study, according to the data collected with the help of the following:

I. Case registration form with detailed history and examinations
II. Follow-up assessment proforma

Data monitoring and coding will be done by the principal investigator and co-investigator. Data entry will be done in soft copy and case record form in hard copy. The values will be verified twice before submission in soft copy. Each file of the patient is secured with a specific patient code.

The data obtained will be calculated using the Student’s Paired ‘t-test and Unpaired ‘t’ test for objective variables with SPSS statistical software.

To verify the significance of the results

Improvements in Fugl-Meyer assessment-35%, one leg stance test-20%, functional reach test-35%, quality of life scale-25%, Barthel index-25% and NIH stroke-scale-score-20% will be considered as significant.

Discussion

Cerebrovascular accidents (CVA) can be correlated with Pakshaghata in Ayurveda. Its pathophysiology evolves in Shira (head). In Ayurveda, Panchakarma is considered the most effective regime to break the pathogenesis of the disease from the root and avoid its recurrence. Snehana, Swedana, including Vasti, is the ultimate treatment modality for Pakshaghata. Acharya Sushruta stated that Vasti is half of the entire management of diseases having chronic and deeply rooted pathology, primarily for conditions originating from the morbid Vata Dosha.⁸^,⁹ It is the most important as it drastically expels the vitiated Vata responsible for the movements of all Dosha, Dhatu, and Mala within the body. Niruha Vasti serves the purpose of the elimination of vitiated Vata Dosha. As Shosha of Sira and Snayu, which is the most critical event in the Samprapti of Pakshaghata, the Bruhana effect induced by Anuvasana Vasti, which pacifies Vata. Being an obstinate Vata disorder, Pakshaghata demands a pioneering treatment of Vata, i.e., Vasti, especially Shodhana or Bruhana Vasti, for a more extended period. Therefore, Vasti is considered one of the foremost treatments for Pakshaghata, capable of eliminating Doshas from the body.¹⁰^,¹¹ It sustains life by maintaining the harmony between Dosha, Dhatu, and Mala in the body.¹²^,¹³

Among various types of Niruha Vasti Dravyas, Dashamula, i.e., a combination of the 10 drugs, is the best Tridoshahara, especially has Vatahara property; therefore, it is highly efficacious for Vata predominant disorders. Dashmoola Niruha Vasti & Anuvasana Vasti with Dashmoola Oil are considered very effective, providing additional benefits of Shodhana and Rasayana, which are expected in Pakshaghata.¹⁴^–¹⁶

Due to this devastating and refractory nature of Pakshaghata, a minimum course of three months of appropriate treatment is recommended. Therefore, among detoxification procedures, Karma Vasti (course of 30 Vasti having a regime of alternate 18 Anuvasana Vasti and 12 Niruha Vasti) with Snehana and Swedana are selected for this study.¹⁷^–²⁰

Local Snehana and Swedana is the mandatory pre-procedural protocol before administering both Niruha and Anuvasana Vasti that is helpful to achieve expected proper procedural symptoms (i.e., Samyak Niruha and Anuvasana Vasti Lakshana). Moreover, it also increases the therapeutic outcome of these therapies by improving blood circulation in that local region.

As local massage nourishes the muscular tissue and fomentation with Dashmool decoction, massage quickly relieves the extremities’ stiffness, especially muscular tissues. Both these procedures also play an important role in enhancing the speed of rehabilitation of the stroke, resulting in a speedy recovery in cognitive functions hampered in it. According to Ayurveda, vitiation of Vata is the most important factor responsible for inducing impairment of cognitive functions and musculoskeletal movements. Both procedures were done by using Dashmoola oil and Dashmoola decoction, respectively, to pacify vitiated Vata due to their Snigdha & Ushna Guna. Moreover, both improve the gait of the patient & reduce the dependency of the affected individual on relatives.²¹^,²² Local massage and fomentation with Vata pacifying medicines improve the patient’s quality of life by building confidence and contributing to induce expected positive outcomes.²³

On the other hand, the efficacy of physiotherapy, especially of the “Motor Relearning Program” (MRP) and “Functional Electrical Stimulation” (FES) in the early rehabilitation of the stroke can be justified as follows:

Motor learning theory underpins the Motor Relearning Programme (MRP). Carr and Shepherd claimed that motor control training necessitates anticipatory acts as well as continuing exercise. The motor relearning program is useful for improving a group of post-stroke patients’ balance function and functional performance. It consists of four distinct steps, i.e., to analyze the task and practice the missing component and task with a transference of training. Eight studies suggested that MRP planned for five weeks showed better improvement in functional performance on self-care, instrumental activities of daily living, and integration into the community hospital.²⁴

The FES is based on electrical stimulation to the peripheral nerves that innervate the paralyzed muscle to generate action potentials in motor neurons, propagating towards the power, and causing its contraction. According to John E.R. 1999 et al. and Niu et al., 2019, it is an excellent recovery tool for motor functions hampered in post-stroke conditions.

Both MRP and FES are quite useful to regain full mobility in such patients, enhance muscle strength and endurance, expand movement capacity, reduce atrophy, increase walking speed, reduce spasticity, and relieve pain. This technique is quite effective to improve the swing phase of the gait, correct a foot drop and decrease the energy expenditure during walking by restoring ankle dorsiflexion affected in the patient with stroke.²⁵^,²⁶

In a nutshell, all-composite treatment modalities induce restoration of gross and fine movements, increase gait speed to the maximum extent quicker, decrease falls, and improve he patient’s quality of life.

Conclusion

Shreds of evidence generated from the current study may prove the positive benefits of the use of integrative approach of Dashamool Niruha Vasti in Panchakarma added with MRP and FES in physiotherapy, to improve gait and speed of movement, decrease the rate of fall while standing or walking, and improves quality of life of patients having stroke. This treatment protocol may become an effective tool in the rehabilitation of such patients, which may broaden the scope of Ayurveda in neurology.

Glossary

Abhighatajanya – Trauma

Anuvasana Vasti – Oil enema

Bahya Snehana – Especially external oleation

Dashmool – Combination of 10 Ayurveda drugs

Dhatu – Body tissues

Dosha – Bio-humours

Karma Vasti – Alternate regime of decoction enema & medicated oil enema for complete one month

Kayachikitsa department – Medicine department

Mala – Body toxins

Niruha Vasti – Decoction enema

Niruha Vasti Dravyas – Decoction enema content

Pakshaghata – Paralysis

Panchakarma department – Purification Putative treatment department

Panchkarama – Purification putative treatment

Rasayana – Rejuvenation

Samprapti – Pathophysiology

Shira – Head

Shodhana – Purification

Snigdha Guna – Unctuousness quality

Swedana – Sudation therapy

Tridoshahara – Bio-humour enhancer

Ushna Guna – Hot quality

Vasti – Medicated Enema

Vata Dosha – Air entity in the body

Vatahara – Air entity pacifier

Data availability

No data are associated with this article.

Reporting guidelines

Figshare: SPIRIT checklist for ‘Efficacy of Dashmool Vasti as an adjuvant therapy with the standard of care (modern + physiotherapy) in the rehabilitation of stroke as compared to standard of care – a clinical trial protocol’. https://doi.org/10.6084/m9.figshare.24488059.

Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication).

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Version 3

VERSION 3 PUBLISHED 14 Dec 2023

Author details Author details

Punam Sawarkar
Roles: Conceptualization, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Vaishali Kuchewar
Roles: Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Gaurav Sawarkar
Roles: Conceptualization, Writing – Original Draft Preparation, Writing – Review & Editing

Irshad Qureshi
Roles: Writing – Original Draft Preparation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (3)

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Published: 10 Apr 2024, 12:1589

https://doi.org/10.12688/f1000research.141553.3

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Published: 15 Feb 2024, 12:1589

https://doi.org/10.12688/f1000research.141553.2

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https://doi.org/10.12688/f1000research.141553.1

© 2023 Sawarkar P et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Sawarkar P, Kuchewar V, Sawarkar G and Qureshi I. Efficacy of Dashmool Vasti as an adjuvant therapy with the standard of care (modern + physiotherapy) in the rehabilitation of stroke as compared to standard of care – a clinical trial protocol [version 1; peer review: 1 approved with reservations]. F1000Research 2023, 12:1589 (https://doi.org/10.12688/f1000research.141553.1)

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Reviewer Report 22 Jan 2024

Neha Tank, Department of Panchkarma, Institute of Teaching and Teaching in Ayurveda (Institute of national Importance) Ministry of Ayush, Jamnagar, Gujarat, India

Approved with Reservations

https://doi.org/10.5256/f1000research.155010.r231867

grammatical corrections required.
Spell check e.g. Kwatha not Quath
Basti not Vasti
Non English words (Sanskrit) may be in Italic
Assessment criteria is not submitted, study results in terms of demographic data, clinical data, blood report changes and statistical analysis are not submitted.
duration of basti is too long for any stroke patient.
Any findings related to adverse effect/complication of Basti?
study details regarding effect of Basti is not submitted

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Panchakarma, Autoimmune diseases, Neurological diseases, Osteomuscular diseases, degenerative diseases, Stress and allergies

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Author Response 13 Apr 2024

punam sawarkar, Mahatma Gandhi Ayurved College Hospital and Research Centre, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India

13 Apr 2024

Author Response

Dear Madam,
The updated version of the manuscript incorporates helpful comments, including correcting grammatical errors; all Ayurveda terms are made italic, Kwatha and Basti's spelling has been corrected, and Assessment criteria ... Continue reading Dear Madam,
The updated version of the manuscript incorporates helpful comments, including correcting grammatical errors; all Ayurveda terms are made italic, Kwatha and Basti's spelling has been corrected, and Assessment criteria are specified in the text.

Because the current manuscript is a PROTOCOL instead of an original article, so some suggestions of respected reviewers can not be incorporated. (For example, study results regarding demographic data, clinical data, blood report changes, and statistical analysis are not submitted, any findings relating to adverse effects/complications of Basti?, and study details addressing the effect of Basti are not submitted.)

According to reviewers, the duration of Basti is too long for any stroke patient; nonetheless, the author submits that due to the devastating and refractory character of Pakshaghata, a minimum term of three months of proper treatment is advised. As a result, Karma Basti (a 30-day detoxification regimen consisting of 18 Anuvasana Basti and 12 Niruha Basti) with Snehana and Swedana was chosen for this study.
Dear Madam,
The updated version of the manuscript incorporates helpful comments, including correcting grammatical errors; all Ayurveda terms are made italic, Kwatha and Basti's spelling has been corrected, and Assessment criteria are specified in the text.

Because the current manuscript is a PROTOCOL instead of an original article, so some suggestions of respected reviewers can not be incorporated. (For example, study results regarding demographic data, clinical data, blood report changes, and statistical analysis are not submitted, any findings relating to adverse effects/complications of Basti?, and study details addressing the effect of Basti are not submitted.)

According to reviewers, the duration of Basti is too long for any stroke patient; nonetheless, the author submits that due to the devastating and refractory character of Pakshaghata, a minimum term of three months of proper treatment is advised. As a result, Karma Basti (a 30-day detoxification regimen consisting of 18 Anuvasana Basti and 12 Niruha Basti) with Snehana and Swedana was chosen for this study.
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Author Response 13 Apr 2024

punam sawarkar, Mahatma Gandhi Ayurved College Hospital and Research Centre, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India

13 Apr 2024

Author Response

Dear Madam,
The updated version of the manuscript incorporates helpful comments, including correcting grammatical errors; all Ayurveda terms are made italic, Kwatha and Basti's spelling has been corrected, and Assessment criteria ... Continue reading Dear Madam,
The updated version of the manuscript incorporates helpful comments, including correcting grammatical errors; all Ayurveda terms are made italic, Kwatha and Basti's spelling has been corrected, and Assessment criteria are specified in the text.

Because the current manuscript is a PROTOCOL instead of an original article, so some suggestions of respected reviewers can not be incorporated. (For example, study results regarding demographic data, clinical data, blood report changes, and statistical analysis are not submitted, any findings relating to adverse effects/complications of Basti?, and study details addressing the effect of Basti are not submitted.)

According to reviewers, the duration of Basti is too long for any stroke patient; nonetheless, the author submits that due to the devastating and refractory character of Pakshaghata, a minimum term of three months of proper treatment is advised. As a result, Karma Basti (a 30-day detoxification regimen consisting of 18 Anuvasana Basti and 12 Niruha Basti) with Snehana and Swedana was chosen for this study.
Dear Madam,
The updated version of the manuscript incorporates helpful comments, including correcting grammatical errors; all Ayurveda terms are made italic, Kwatha and Basti's spelling has been corrected, and Assessment criteria are specified in the text.

Because the current manuscript is a PROTOCOL instead of an original article, so some suggestions of respected reviewers can not be incorporated. (For example, study results regarding demographic data, clinical data, blood report changes, and statistical analysis are not submitted, any findings relating to adverse effects/complications of Basti?, and study details addressing the effect of Basti are not submitted.)

According to reviewers, the duration of Basti is too long for any stroke patient; nonetheless, the author submits that due to the devastating and refractory character of Pakshaghata, a minimum term of three months of proper treatment is advised. As a result, Karma Basti (a 30-day detoxification regimen consisting of 18 Anuvasana Basti and 12 Niruha Basti) with Snehana and Swedana was chosen for this study.
Competing Interests: Nil Close
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Version 3

VERSION 3 PUBLISHED 14 Dec 2023

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Version 3 (revision) 10 Apr 24		read
Version 2 (revision) 15 Feb 24	read	read
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Neha Tank, Institute of Teaching and Teaching in Ayurveda (Institute of national Importance) Ministry of Ayush, Jamnagar, India
Aishwarya Ashish Joglekar, All India Institute of Ayurveda, New Delhi, India

Sumedh Joshi, All India Institute of Ayurveda, New Delhi, India

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13 Apr 2024 | for Version 3

Aishwarya Ashish Joglekar, Samhita Siddhant, All India Institute of Ayurveda, New Delhi, New Delhi, India

Sumedh Joshi, Dravyaguna, All India Institute of Ayurveda, New Delhi, New Delhi, India

5 Views Cite this report Responses(0)

Approved

I have no further comments to make. Great Effort on the part of the Authors

Competing Interests

No competing interests were disclosed.

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Ayurveda, Endocrinology , Musculoskeletal system, Preventive health

We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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27 Mar 2024 | for Version 2

Aishwarya Ashish Joglekar, Samhita Siddhant, All India Institute of Ayurveda, New Delhi, New Delhi, India

Sumedh Joshi, Dravyaguna, All India Institute of Ayurveda, New Delhi, New Delhi, India

16 Views Cite this report Responses(1)

Approved With Reservations

This is a well written article considering important protocol for management of Pakshaghata as per principles of Ayurveda. Few modifications are however required which are communicated earlier-

In the sentence - "He will keep the original random allocation sequences in a secure third location and work with an alternate copy"- Grammatical Correction is required

Correct the sentence- Acharya Sushruta states that Basti contributes to more than half to the management of diseases having chronic and deeply rooted pathology and is primarily helpful for conditions originating from the morbid Vata Dosha.

Give reference - Local Snehana and Swedana is the mandatory pre-procedural protocol before administering both Niruha and Anuvasana Basti and is helpful to achieve expected proper procedural symptoms (i.e., Samyak Niruha and Anuvasana Basti Lakshana).

massage quickly relieves the extremities’ stiffness, especially muscular tissues. Use term instantaneously instead of quickly

Give reference for the statement- As local massage nourishes the muscular tissue and fomentation with Dashmool decoction, massage quickly relieves the extremities’ stiffness, especially muscular tissues. Both these procedures also play an important role in enhancing the speed of rehabilitation of the stroke, resulting in a speedy recovery in cognitive functions hampered in it. According to Ayurveda, vitiation of Vata is the most important factor responsible for inducing impairment of cognitive functions and musculoskeletal movements.

Bahya Snehana – Especially external oleation omit the word especially
Tridoshahara- Bio-humour Alleviator

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Ayurveda, Endocrinology , Musculoskeletal system, Preventive health

We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however we have significant reservations, as outlined above.

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8 Views

28 Feb 2024 | for Version 2

Neha Tank, Department of Panchkarma, Institute of Teaching and Teaching in Ayurveda (Institute of national Importance) Ministry of Ayush, Jamnagar, Gujarat, India

8 Views Cite this report Responses(0)

Approved

I have no further comments.

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Panchakarma, Autoimmune diseases, Neurological diseases, Osteomuscular diseases, degenerative diseases, Stress and allergies

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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17 Views

22 Jan 2024 | for Version 1

Neha Tank, Department of Panchkarma, Institute of Teaching and Teaching in Ayurveda (Institute of national Importance) Ministry of Ayush, Jamnagar, Gujarat, India

17 Views Cite this report Responses(1)

Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Panchakarma, Autoimmune diseases, Neurological diseases, Osteomuscular diseases, degenerative diseases, Stress and allergies

Respond to this report

Responses (1)

Author Response

13 Apr 2024

punam sawarkar, Mahatma Gandhi Ayurved College Hospital and Research Centre, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India

Dear Madam,
The updated version of the manuscript incorporates helpful comments, including correcting grammatical errors; all Ayurveda terms are made italic, Kwatha and Basti's spelling has been corrected, and Assessment criteria are specified in the text.

Because the current manuscript is a PROTOCOL instead of an original article, so some suggestions of respected reviewers can not be incorporated. (For example, study results regarding demographic data, clinical data, blood report changes, and statistical analysis are not submitted, any findings relating to adverse effects/complications of Basti?, and study details addressing the effect of Basti are not submitted.)

According to reviewers, the duration of Basti is too long for any stroke patient; nonetheless, the author submits that due to the devastating and refractory character of Pakshaghata, a minimum term of three months of proper treatment is advised. As a result, Karma Basti (a 30-day detoxification regimen consisting of 18 Anuvasana Basti and 12 Niruha Basti) with Snehana and Swedana was chosen for this study.

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Competing Interests

Nil

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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[9] 9. A Clinical Study To Evaluate The Efficacy Of Dwi-Panchamula Niruha yesVasti In Pakshaghata”PG Thesis Submitted By Dr. Prakash Paltye, Department Of Panchakarma, SDMCA Udupi. In Rajiv Gandhi University Of Health Sciences, Karnataka, Bangalore, 2010-11.

[10] 10. Samhita AC, editor. Jadavji Trikamji Acharya,5^th edition Chaukamba publication Varanasi.2001; pp. 738. page no: 619.

[11] 11. Sena V, Samhita VS: edited by Kavivar Sri Saligramaji Vaishya Dec-2003, Kaumarajsri Krishna Das Prakashan Mumbi. pp. 1069. page no: 983.

[12] 12. Dr.Kaur Mandeep: A clinical study on the effect of Panchaprasritiki Niruha yesVasti in Pakshaghata Dept of Panchakarma SDMCA Udupi, RGUHS, Bangalore in 2007-2008.

[13] 13. Dr.Upadhyaya Asha: A clinical study on the effect of Upanaha Sweda in Pakshaghata, Dept of Panchakarma SDMCA Udupi, RGUHS Bangalore in 2007.

[14] 14. Agnivesha CS, editor. Jadavji Trikamji Acharya reprint 2007 Chaukamba orientalia Golgahar Varabnasi.2007; pp. 738. page no: 619

[15] 15. Manish K, Kumudini K, Mala K: B.B. Conceptual And Therapeutic Study Of Pakshaghata. Int. J. Appl. Ayurved Res. 2017; 3(1): 48–56.

[16] 16. Patel J, et al.: A non-randomized observational clinical study on ayurvedic treatment in pakshaghata. Journal of biological & scientific opinion 2015; 3(5): 230–234. Publisher Full Text

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[18] 18. Dr.Patanjali: A clinical study on the effect of Agni chikitsa in Pakshaghata, Dept of Panchakarma SDMCA Udupi, RGUHS Bangalore in 2006.

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[20] 20. Dr.U Shreekanth: “studies on some systematic effect of yesVasti with special reference to Gridhrasi, Viswachi and Pakshavadha” undertaken at IPGT&R, Gujarat Ayurveda University – Jamnagar in 1984. L-1416.

[21] 21. Sawarkar G, Sawarkar P: Management Of Ardita (Bell’s Palsy) Through Ayurveda- A Case Study. Int. J. Recent Sci. Res. April, 2019; 10(04): 32040–32043.

[22] 22. Singh N, Dubey S: Evaluate The Efficacy Of Shashtik-Shali Pinda Sweda And Abhyanga In Management Of Pakshaghata Along With Virechana Wsr To Hemiplegia. Int. J. Ayurveda Pharma. Res. 2020 Jul 12; 1–2. Publisher Full Text

[23] 23. Kumar DR: The role of Panchakarma therapy in musculoskeletal disorders with special reference to vatavyadhi. Global Journal of Research on Medicinal Plants & Indigenous Medicine. 2013; 2(1): 23.

[24] 24. Krutulyte G, Kimtys A, Krisciūnas A: The effectiveness of physical therapy methods (Bobath and motor relearning program) in the rehabilitation of stroke patients. Medicine (Kaunas, Lithuania). 2003; 39(9): 889–895.

[25] 25. Niu CM, Bao Y, Zhuang C, et al.: Synergy-based FES for post-stroke rehabilitation of upper-limb motor functions. IEEE Trans. Neural Syst. Rehabil. Eng. 2019 Feb 8; 27(2): 256–264. PubMed Abstract | Publisher Full Text

[26] 26. Eraifej J, Clark W, France B, et al.: Effectiveness of upper limb functional electrical stimulation after Stroke to improve activities of daily living and motor function: a systematic review and meta-analysis. Syst. Rev. 2017 Dec 1; 6(1): 40. PubMed Abstract | Publisher Full Text | Free Full Text

Efficacy of Dashmool Vasti as an adjuvant therapy with the standard of care (modern + physiotherapy) in the rehabilitation of stroke as compared to standard of care – a clinical trial protocol

Abstract

Background

Aim & Objectives

Methods

Expected results

Conclusions

Trial registration

Keywords

Introduction

Methods

Ethical considerations

Study design

Sample size

Recruitment

Setting

Participants

Eligibility criteria

Interventions

Table 1. Methodology of the study.

Figure 1. Study design including grouping, intervention, assessment plan and follow-up.

Assessment tools

Variables to be measured

Participant timeline

Assignment of interventions (for controlled trials)

Data collection, management, and analysis methods

Discussion

Conclusion

Glossary

Data availability

Reporting guidelines

References

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