Keywords
Grudhrasi,Sciatica,katipradesh,Ruka,Rasonapinda,trayodashang guggul,katibasti,dashmool taila.
This article is included in the Datta Meghe Institute of Higher Education and Research collection.
In ayurveda, sciatica can be correlated to ‘Grudhrasi’ under Vata Nanatmaja-Vyadhi (neurological disorders caused by Vata, one of the bodily humour). In this mainly bodily humours vata and kapha are vitiating producing symptoms like piercing pain, stiffness, twitching, numbness and pain radiating from lumbosacral region to lower limb up to the foot. Therapeutic plan includes stabilizing and bringing back the vitiated vata and kapha humours to equilibrium. The prevalence of sciatica varies considerably ranging from 3.8% in the working population to 7.9% in the nonworking population.
Comparative evaluation of efficacy of Rasonapinda and Trayodashang guggul as an adjuvant to katibasti (oil pooling therapy) in the management of Grudhrasi (Sciatica).
To assess the efficacy of Rasonapinda as an adjuvant to katibasti in subjective and objective parameters of Grudhrasi (Sciatica). To assess the efficacy of Trayodashang guggul as an adjuvant to katibasti in subjective and objective parameters of Grudhrasi (Sciatica). To compare the efficacy of Rasonapinda and Trayodashang guggul as an adjuvant to katibasti in subjective and objective parameters. Standardisation of Rasonapinda (modified formvati).
In this study, a total of 60 patients will be enrolled and divided equally into two groups. In group A, Trayodashang Guggul 500 mg twice a day after meal with warm water for 30 days adjuvant with katibasti for the initial 7 days will be given. In group B, Rasonapinda 500 mg twice a day after meal with warm water adjuvant with katibasti for the initial 7 days will be given for 30 days.
The result will be assessed on baseline of subjective and objective parameters and data will be compared after treatment.
It will be based on observations and results obtained.
CTRI No. - CTRI/2022/12/048534 Dated – 27/12/2022.
Grudhrasi,Sciatica,katipradesh,Ruka,Rasonapinda,trayodashang guggul,katibasti,dashmool taila.
Changed the study setting and mentioned controlled group & interventional group as suggested by the reviewer and made necessary corrections as suggested.
See the authors' detailed response to the review by Vaibhav Bapat
See the authors' detailed response to the review by Shrilatha Kamath
Grudhrasi is a pain dominant (Vata Nanatmaja Vyadhi) neurological disorder. It is identified by pain in the lower back region which radiates downwards to the lumbar, lower back, thigh, popliteal area, calf region, and foot.1 Acharya Charak has described two types of Grudhrasi Vata dominant and Vata-Kapha dominant. The Vata dominant type of Grudhrasi is characterized by pain starting from buttock and then radiates to the lumbar, lower back, thigh, popliteal area, calf, and foot along with stiffness, pain, pricking sensation, and twitching. Whereas in Vata-Kapha dominant type of Grudhrasi, aversion to food, drowsiness, and feeling of heaviness are found, which causes the restricted movement of lifting of the leg.2 In modern science grudhrasi can be correlated with Sciatica due to similarity in symptoms like severe radiating pain that spreads down one or both legs along the sciatic nerve that originates in the lower back. Sciatica is a crippling condition in which the patient feels pain and/or paraesthesias in the sciatic nerve’s or a related lumbo sacral nerve root’s distribution.3 The disorder has a significant socio economic impact and has the potential to become chronic and irreversible.4 Iin India, 2-40 percent of individuals suffer from sciatica. This occurrence is age-related and unlikely before the age of 20. According to reports, 1 to 10% of the population can suffer sciatica, with individuals aged 25 to 45 being the most commonly affected.5 In modern management of sciatica, mostly non-steroidal anti inflammatory drugs (NSAIDSre used and symptomatic treatment is done. Ayurveda has many more effective methods for treating this excruciating condition. In this disease, mainly Apana and Vyana Vayu (types of vata humour in body) vitiation are observed, but most of the times Kapha humour remain associated in pathogenesis of disease. Therefore, the recommended medicine for treating Grudhrasi should be vata pacifying, kapha pacifying, and one which normalizes vata movement in body.6 Besides this, medicine should be digestive-carminative, and pain alleviating in properties. In Bhaishajya Ratnavali (one of the classics if ayurveda), Rasonapinda is mentioned in the management of Grudhrasi having Rasona (Allium sativum) as a chief ingredient.7 In phytochemical study, the presence of alkaloids in Allium sativum extract shows the potential to have an analgesic, anti-inflammatory, antioxidant and adaptogenic effect. In addition, Katibasti (oil pooling therapy) is a successful method for rejuvenation of body tissues that involves applying and retaining specially prepared heated herbal oil inside a border made of flour that is kept in the lower back for a predetermined amount of time.8 It lubricates the joints, strengthens the muscles and connective tissue, and increases flexibility.
Modern therapy includes the use of analgesics, epidural steroid injections and surgery. It has limitations due to side effects and is expensive. In Ayurveda Oleation, sudation (steam therapy), blood letting, therapeutic heat burn (Agnikarma), enema therapy and palliative therapies are indicated. Palliative therapies are non invasive, simple, safe and cost effective. In classics, various formulations are mentioned for non-invasive therapy like trayodashang guggul, vatari guggul etc.9 In Bhaishajya Ratnavali, Rasonapinda has been mentioned in the management of Grudhrasi. Though vata and kapha are the bodily humour vitiated in Grudhrasi, the impact of digestive fire is not ignored in the pathogenesis of Grudhrasi. Rasonapinda is totally herbal in nature having analgesic, anti-inflammatory, digestive, carminative properties which will help in correcting weak digestive fire and reducing symptoms like pain, and stiffness.10 Consequently, this research is being done to assess the efficacy of Rasonapinda in the management of Grudhrasi (sciatica).
Comparative evaluation of efficacy of Rasonapinda and Trayodashang guggul as an adjuvant to katibasti (oil pooling therapy) in the management of Grudhrasi (sciatica).
1) To assess the efficacy of Rasonapinda as an adjuvant to katibasti in subjective and objective parameters of Grudhrasi (sciatica).
2) To assess the efficacy of Trayodashang guggul as an adjuvant to katibasti in subjective and objective parameters of Grudhrasi (sciatica).
3) To compare the efficacy of Rasonapinda and Trayodashang guggul as an adjuvant to katibasti in subjective and objective parameters.
4) Standardisation of Rasonapinda (modified form-vati).
The patients will be selected from OPD and IPD of department of kayachikitsa of the Mahatma Gandhi Ayurved College, Hospital & Research Centre, Salod (H) and peripheral camps, mainly the population of Wardha district including patients of all community, (Maharashtra) India. A total of 60 patients will be recruited for the study. They will randomly be divided into two groups; Group A (controlled group) – Trayodashang Guggul, and Group B (interventional group) – Rasona Pinda. All the baseline parameters will be recorded at the start of the study. The patients will undergo treatment for 30 days for both groups. All the parameters will be recorded at the 0th, 15th, 30th, 45th day of the study duration.
Sample size: 60 (including sample size calculation).
Grouping: Group A (controlled group) – (n=30) Trayodashang Guggul as an adjuvant to katibasti (oil pooling therapy).
Group B (Interventional group) – (n=30) Rasonapinda as an adjuvant to katibasti (oil pooling therapy).
All the baseline parameters will be recorded at the beginning of the study. The patients will undergo treatment for 30 days in both groups. Follow ups will be taken on the 15th and 30th days during treatment and the 45th day after treatment.
Guidelines: The SPIRIT guidelines were used for the study protocol.11
Case definition: Patients between 20–60 years of either sex having classical signs and symptoms of Grudhrasi (sciatica) willing to give written informed consent.
Sampling procedure: Simple random sampling by computerized table method.
Type of study: Interventional study.
Study design: Randomized standard controlled single-blind superiority clinical trial.
Simple randomization method will be used to allocate participants in controlled and interventional group. A Random number generator will be used and unique number is given to each participant. Participant with even number will be allocated in controlled group and participant with odd number will be allocated in Interventional group.
Data monitoring: formal committee.
The ethical clearance for the publication of this protocol was taken from the I.E.C. committee at Mahatma Gandhi Ayurveda College, Hospital and Research Centre Salod (H), Wardha, Datta Meghe Institute of Medical Sciences with Ref No.-MGACHRC/IEC/july-2022/549 (11/08/22).
CTRI registration for this study – CTRI/2022/12/048534 (27/12/2022).
The committee will decide on the endpoint and oversee the trial as it progresses.
The researcher will assess any adverse event and these will be reported to the ethics committee.
Consent – The recruitment of the patient in study groups will be done with written informed consent in their local language while explaining every aspect of the study by the researcher.
Before, during, and after the experiment, the participants’ personal data will be gathered and kept private. The researcher will be the only one having access to the physical data storage facility. Computerised information will be kept on a hard drive that is password-protected and only the researcher can access it.
Inclusion criteria – Patients willing to participate with written informed consent.
Patients aged between 20–60 yrs.
Patients having classical sign and symptoms of Grudhrasi Ruk (pain), Stambha (stiffness), Toda (pricking pain), Muhuspandana (numbness), Aruchi (anorexia), Tandra (drowsiness).
Patient fulfilling diagnostic criteria like positive SLRT, Schober’s test, Bowstring Test.
Exclusion criteria – Cases of traumatic injury.
Known cases of bone tumour, cancer of spine, tuberculosis of vertebral column, fibrosis of sacral ligaments, and protruded inter vertebral disc except lumbar spondylosis.
Patients with serious health issues such as diabetes mellitus, heart disease, kidney disease, cancer, tuberculosis, and other systemic disorders.
Pregnant and lactating women.
If any unintended adverse effects or complications develop while receiving therapy, the patient will be removed from study and receive free care for those issues until they are resolved.
Group B (Interventional group) – Rasonapinda12 500 mg twice a day with water
Ingredients of Rasonapinda are Allium sativum (Rasona 72 gm), Ferula asafetida (Hingu 12 gm), Cuminum cyminum (Jeeraka 12 gm), Sodiichloridum (Saindhavlavana and Souvarchalalavana 12 gm each), zingiber officinale (Shunthi 12 gm), Piper nigrum (Maricha 12 gm), Piper longum (Pippali 12gm), Ricinus communis (Eranda- Quantity sufficient).
Group A (Controlled group) – Trayodashang guggul13,14 500 mg twice a day with water
Ingredients of Trayodashang guggul are 13 parts Commiphoramukul (Guggul), 1 part of each-Acasia Arabica (Aabha), Withaniasomnifera (Ashwagandha), Juniperus communis (Harpusha), Tinospora cordifolia (Guduchi), Asparagus recemosus (Shatavari), Tribulus terresteris (Gokshur), Argyria speciosa (Vriddhadaru), Pluchea lanceolata (Rasna), Foeniculumvalgare (Shatapushpa), Curcuma zedoaria (Karchur), Trachhyspermumammi (Yavani), Zingiber officinale (Shunthi), 1/2 part of Clarified butter (Ghrut).
Adjuvent Therapy – katibasti (oil pooling therapy) with Dashmoola oil
Dashmoola oil literally means oil prepared of 10 roots of medicinal herb is a polyherbal preparation pacifying all three bodily humours (vata, pitta and kapha), more specifically having vata pacifying effect mentioned in bhaishajyaratnavali under the management of brain disorders (Shirorogadhikar). It is a well-known for alleviating Vata type of bodily humour by oleation therapy.15
Ingredients of Dashmool oil are 1 part each of roots of Aegle marmelos (Bilwa), Premna serratifolia (Agnimantha), Oroxylum indicum (Shyonak), Stereospermum suaveolance (Patala), Gmelina arborea (Gambhari), Desmodiumgangeticum (Shalaparni), Uraria picta (Prishniparni), Solanum indicum (Brihati), Solanum surattense (Kantakari), Tribulus terrestris (Gokshura), Vitex negundo (Nirgundi), Brassica comprestris (Sarshap).
Rasonapinda will be prepared according to the standard operating procedures outlined in Sharangdhar Samhita- Madhyam Khand (ayurveda classics).
Rasonapinda will be prepared according to modified form by giving three bhavanas (triturations) of erandmool decoction and converting it into tablet form for easy acceptability and convenience to the patient and further standardization of Rasona Pinda will be done.16
Fine powder of all ingredients- Allium sativum (Rasona 72 gm), Ferula asafetida (Hingu 12 gm), Cuminum cyminum (Jeeraka 12 gm), Sodiichloridum (Saindhavlavana and Souvarchalalavana 12 gm each), zingiber officinale (Shunthi 12 gm), Piper nigrum (Maricha 12 gm), Piper longum (Pippali 12 gm) will be taken and mixed thoroughly. To this powder, ricinus communis root (erandmool) decoction will be added and triturated for three hours. Such three triturations (bhavanas) will be given. After drying granules will be prepared and tablet of each 250 mg will be prepared by tablet punching machine.
Trayodashang Guggul and Dashmool Taila will be procured from a pharmaceutical company.
Any unfavourable effects during the course of the treatment will be observed and will be reported to the ethical committee. The patients’ unpleasant effects will be taken care of. Any withdrawal requests from participants will be addressed along with the justification for ending the course of therapy.
To compare efficacy of Rasonapinda and Trayodashang guggul as an adjuvant to katibasti (oil pooling therapy) in subjective and objective parameters.
Assessment will be done on 0th, 15th, 30th day during treatment and 45th day after treatment
Ruk (pain)
Stambha (stiffness)
Toda (pricking pain)
Muhuspandana (numbness)
Aruchi (anorexia)
Tandra (drowsiness)
Functional disability – Oswestry Disability Assessment Questionnaire
SLRT (Straight Leg Raising test)
Walking time – to cover 25 meters
Schober’s Test
Bowstring test
Questionnaire description: Each of the 10 sections that describe the pain and its effects is evaluated from 0 to 5, with higher values indicating a more severe impact.
Schober’s test
Locate L5 spinous process (level of posterior superior illiac spine, dimpuls of venus).
Mark 5 cm below and 10 cm above.
Requesting the patient to touch their toes.
Measure the space between the marks.
Normal > 5 cm, Abnormal< 2.5 cm
Bowstring test
Subject is supine.
Passively perform SLR on the involved side, if the pain is experienced, flex the subject’s knee to 20 degrees in attempt to reduce the pain.
After that, exert pressure there in an effort to simulate radicular pain.
(+) Tension on the sciatic nerve is indicated by painful radicular reproduction after popliteal compression.
Patients will be treated for 30 days and assessment will be done up to 45 days as mentioned in Figure 1.
As per sample size calculation, total patients will be recruited. Data collected will be analyzed by using appropriate statistical methods. The patients of Grudhrasi will be selected from the Kayachikitsa Out-patient department and In-patient department of Mahatma Gandhi Ayurved College, Hospital & Research Centre, Salod (H), and from specialized peripheral camps.
Enrolment and interventions time schedule
The intervention period will be from 0 to 30 days and follow up on the 0th, 15th, 30th and 45th day.
Sample size
Formula using Mean difference:
Primary Variable = Radiation of Pain
(Mean) value of Radiation of Pain for Trayodashangguggul treatment group (Before) = 2.27 (As per reference article).19
(Mean) value of Radiation of Pain for Trayodashangguggul treatment group (After) = 0.93.
Mean Difference for the effect in Trayodashangguggul after and before 2.27 – 0.93 = 1.34.
Standard Deviation = 0.62
Considering 20% clinically relevant margin for RasonaPinda = (1.34 *35) /100 = 0.469.
Sample size N =
Considering 10% drop out = 2
Total sample size required = 28 + 2 = 30 per group.
A total of 60 patients will be recruited for the study.
Allocation sequence generation – Computer-Generated Randomization.
Concealment of allocation – assessor blinding.
Allocation implementation – the first author will generate an allocation sequence, enrol participants, and assign participants to intervention.
Blinding – randomized single blind standard controlled superiority clinical trial.
The outcome assessor will be blinded.
Unblinding will not be permissible to outcome assessor.
Participant will be revealed about allocation of intervention at the time of enrolment.
Data will be record and assessed as per the subjective and objective criteria on 0th, 15th, 30th & 45th of study (see Table 1).
Ayurveda samhitas
Modern texts
Online search – Google scholar, etc.
60 patients
TrayodashangGuggul
RasonaPinda
Case record form
Patients information form
Written and informed consent form
Measuring scale
Sphyghmomanometer
Weighing machine
Data obtained from the follow up chart and other observations will be used and the results will be drawn on the basis of various charts, graphs, and tables. To determine the relevance of the findings, improvement in patient condition as per assessment criteria, after treatment will be noted as significant.
Drug collection/authentication
The department of Dravyaguna and Rasashastra of Mahatma Gandhi Ayurved college hospital and Research Center, Salod, Wardha will validate and identify the raw material before it is used to make the medicine. It will be obtained from a reputable source.
Statistical methods
Descriptive statistics will summarize baseline characteristics. Baseline comparisons between groups will be conducted using independent t-tests for continuous variables and Chi-square tests for categorical variables. Primary outcome analysis will involve paired t-tests (or Wilcoxon signed-rank tests) within each group to evaluate changes from baseline, and independent t-tests (or Mann-Whitney U tests) to compare changes between groups. Secondary outcomes will be analyzed using repeated measures ANOVA or mixed-effects models for longitudinal data, and Chi-square tests for categorical outcomes. Regression analyses will adjust for potential confounders.
Study status
IEC Clearance and CTRI registration has been done. Recruitment of patient has started as per the inclusion and exclusion criteria.
This study will compare the therapeutic efficacy of Trayodashang guggul and Rasonapinda adjuvant to katibasti (oil pooling therapy) in individuals with grudhrasi (sciatica). Grudhrasi has been mentioned in classics in ayurveda under vatavyadhi (neurological disorders caused by Vata, one of the bodily humour) where there is radiating pain along with stiffness in buttocks (sphik) that gradually encroaches posterior aspect of lumbosacral region radiating to the thigh, popliteal area, calf up to the foot sequentially. In ayurveda, treatment means to disintegrates the pathogenesis (samprapti).20 In grudhrasi there is mainly vitiation of vata humour along with kapha humour.21 Also, there is derangement of digestive strength with vitiation of bones and muscles and ligaments by their improper nourishment which gives rise to the above-mentioned symptoms. The quality of drugs for disintegration of disease pathogenesis should include vata and kapha pacifying action and which also nourishes the body tissues.22 Trayodashang Guggul is a polyherbal formulation mentioned in ayurveda in which 13 herbs, including guggul, are combined to make Trayodashang Guggul, which is then processed in ghrut (Ghee). Specifically, constituents like Asparagus racemosus (shatavari), Winthania somnifera (Ashvagandha) and Tinospora cordifolia (guduchi) are known as rejuvenators and provides strength to body tissues.23 Trayodashang guggul also have proven anti-inflammatory action. Additionally Ghrut (Ghee) with its catalytic and synergistic action helps in better penetration and absorption of drug.24 Thus trayodashng guggul directly has an impact in disintegration of disease pathogenesis and pacifying vata humour. Rasona Pinda has been mentioned in Bhaisajya Ratnavali (Ayurveda classics) which consists of Rasona (Allium sativum), Trikatu (combination of zingiber officinale, Piper nigrum and Piper longum) and errand (Ricinus communis) as chief ingredients possessing a mainly pungent taste (katu, one of the six taste in ayurveda) and hot in potency.25 Allium sativum is a well-known Kapha and Vata humour pacifying drug. Rasona has rejuvenating action (Rasayan). Being rejuvenating, this medication raise the standard of healthy body tissue production and restored normalcy to the vitiation of bone and tissues. Trikatu (combination of zingiber officinale, Piper nigrum and Piper longum) helps in Ama toxin (undigested food) digestion and enhances digestive fire with its hot potency.26 Trikatu (combination of zingiber officinale, Piper nigrum and Piper longum) has also been shown to be helpful for musculoskeletal diseases, reducing stiffness and swelling.27 Additionally Rasona Pinda tablet given is tritutrated with decoction of roots of Ricinus communis (erandmula). Ricinus communis (erandmula) being sweet, pungent, astringent in taste and unctuous in nature with hot potency will help in combating vitiated vata-kapha bodily humour.28 Kati Basti (oil pooling therapy) with Dashmoola oil (combination of the roots of 10 herbal drugs) relieves stress from muscles and bones, allowing the Srotas (inner channels of body) to function more efficiently.29 It also aids in improved blood circulation and provides flexibility in body movement. Ingredients of Dashamula (combination of the roots of 10 herbal drugs) have Vata and Kapha humour pacifying properties and also possess anti-inflammatory and analgesic action which provides relief from muscular and skeletal discomfort in the back.30
The trial drug could be efficacious in treating grudhrasi (sciatica) as it is a combination of drugs having anti-inflammatory, pain alleviating, rejuvenating and digestive fire strengthening properties that could be helpful in disintegration of pathogenesis.
If RasonaPinda will pacify the symptoms in Grudhrasi (sciatica) and is found to be helpful to perform routine activities then clinical evidence with simple, safe, cost-effective treatment can be generated for the management of Grudhrasi (sciatica).
This protocol will be further published as a thesis to disseminate the study for Grudhrasi (sciatica). The study protocol provides a detailed overview of the study design, methodology, data collection procedures, data analysis plan, and ethical considerations. By disseminating this protocol, we hope to advance knowledge in the field and facilitate future research.
Zenodo: SPIRIT checklist for ‘Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial’. https://doi.org/10.5281/zenodo.8126753. 27
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
I am thankful to my guide, seniors and batchmates for supporting me in publishing this work. The authors are also appreciative of the authors, editors, and publishers of all the papers, journals, and books that were used to review and debate the literature for this work.
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Is the rationale for, and objectives of, the study clearly described?
Partly
Is the study design appropriate for the research question?
Partly
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: Ayurveda, Clinical Yoga
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Medicine, Chest, Locomotor, ENT, Skin, Autoimmune
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Medicine, Chest, Locomotor, ENT, Skin, Autoimmune
Is the rationale for, and objectives of, the study clearly described?
Partly
Is the study design appropriate for the research question?
Partly
Are sufficient details of the methods provided to allow replication by others?
No
Are the datasets clearly presented in a useable and accessible format?
Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Ayurveda, Skin diseases, Musculoskeletal disorders
Is the rationale for, and objectives of, the study clearly described?
Partly
Is the study design appropriate for the research question?
Partly
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
References
1. Rai M, Misar S, Gamne R: Comparative evaluation of efficacy of Trayodashang Guggul versus Rasona Pinda as an adjuvant with Katibasti in the management of Grudhrasi (Sciatica): A randomized controlled trial. F1000Research. 2024; 13. Publisher Full TextCompeting Interests: No competing interests were disclosed.
Reviewer Expertise: MedicineKayachikitsa
Alongside their report, reviewers assign a status to the article:
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