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

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 stroke cases 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 Non-insulin dependent Diabetes Mellitus (NIDDM). Patient with ankle dorsiflexion stage 1 to 2 and ankle plantar flexors spasticity 1+ on. Patients are willing to give informed consent and ready to follow simple instructions.

The exclusion criteria for the study are the patients having a thrombolytic stroke with onset for > 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 be excluded. Patients contraindicated for Basti & Swedana therapy and patients with fixed ankle or foot contracture, pacemakers, 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 800 mg 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 Kwatha + medicated enema (alternate regime of Dashamoola Niruha Basti with Anuvasana Basti with Dashmoola Taila will be prescribed for the treatment. The alternative regime of medicated enema i.e., Anuvasana Basti (oil enema) and Dashamoola Niruha Basti (decoction enema) will be given on odd and even days respectively for one month, and physiotherapy for five days weekly for one month.

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

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 criteria

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 sensory-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

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 follow-up 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 enrols 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 follow-up 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:

The principal investigator and co-investigator will do data monitoring and coding. 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.

Glossary

Abhighatajanya – Trauma

Anuvasana Basti – Oil enema

Bahya Snehana – Especially external oleation

Dashmool – Combination of 10 Ayurveda drugs

Dhatu – Body tissues

Dosha – Bio-humours

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

Kayachikitsa department – Medicine department

Mala – Body toxins

Niruha Basti – Decoction enema

Niruha Basti 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

Basti – Medicated Enema

Vata Dosha – Air entity in the body

Vatahara – Air entity pacifier