| CTRI Number |
CTRI/2025/10/096574 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic Management of Sciatica (Gridhrasi) through Koshtha Shodhana with Eranda Sneha and Vaitarana Basti
|
|
Scientific Title of Study
|
An Open Label Single Arm Clinical Study To Evaluate The Efficacy Of Koshtha Shodhana With Eranda Sneha Followed By Vaitarana Basti In Yogabasti Pattern In The Management Of Gridhrasi (Sciatica) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pavanbhai Jerambhai Sorathiya |
| Designation |
PG Scholar |
| Affiliation |
G. J. Patel Institute Of Ayurvedic Studies And Research |
| Address |
Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120
Anand GUJARAT 388120 India |
| Phone |
6353085168 |
| Fax |
|
| Email |
pavansorathiya1604@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Suma K J |
| Designation |
Associate Professor |
| Affiliation |
G. J. Patel Institute Of Ayurvedic Studies And Research |
| Address |
Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity
Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120
Anand GUJARAT 388120 India |
| Phone |
9742786607 |
| Fax |
|
| Email |
sumakumble@outlook.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Suma K J |
| Designation |
Associate Professor |
| Affiliation |
G. J. Patel Institute Of Ayurvedic Studies And Research |
| Address |
Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity
Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120
Anand GUJARAT 388120 India |
| Phone |
9742786607 |
| Fax |
|
| Email |
sumakumble@outlook.com |
|
|
Source of Monetary or Material Support
|
| S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-
388120 |
|
|
Primary Sponsor
|
| Name |
Dr Pavanbhai Jerambhai Sorathiya |
| Address |
Department Of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity
Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pavanbhai Jerambhai Sorathiya |
S. G. Patel Ayurveda Hospital And Maternity Home |
Department Of Panchakarma, OPD
No. 15, S. G. Patel Ayurveda
Hospital And Maternity Home, New
Vallabh Vidyanagar, Anand, Gujarat,
India-388121 Anand GUJARAT |
6353085168
pavansorathiya1604@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G.J.Patel Institute Of Ayurvedic Studies And Research And S.G.Patel Ayurveda Hospital And Maternity Home Institutional (Human) Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Koshtha Shodhana with Eranda Sneha Followed by Vaitarana Basti in Yogabasti Pattern |
Reference Vangasena Samhita - For Koshtha Shodhana Eranda Sneha will be administered in a dose ranging from 15-30 ml depending upon the Koshtha of the patient.
Reference Vangasena Samhita Basti karma Adhikara
In the proposed Yogabasti protocol, Vaitarana basti will be administered before food with a dosage of 306 ml. The Vaitarana Basti is prepared using specific proportions Guda (jaggery)24gm, Saindhava lavana (rock salt) 12gm, Murchita Tila taila 30ml, Chincha kalka (tamarind pulp) 48gm, Gopaya (cows milk) 192ml.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participant fulfilling diagnostic criteria of Gridhrasi (Sciatica) like Ruk (Pain in lower back region radiating to lower limb) Stambha (Stiffness) Toda (Pricking like pain) Spandana (Twitching in all parts) and Associated symptoms like Aruchi (Anorexia) Tandra (Lethargy) and Gaurava (Heaviness in body)
Participants of either gender and age between 30 to 60 years
Participants willing to follow the prescribed Panchakarma protocol |
|
| ExclusionCriteria |
| Details |
Participants not fit for Matra basti and/or Niruha Basti as per Ayurveda classics
Pregnant and Lactating women
Participants with major systemic illnesses known cases of Uncontrolled Diabetes Mellitus and Hypertension Cardiac disorders Morbid obesity and other diseases which interferes with the course of the treatment
Those who have undergone surgical treatment in affected joints
Participants who report any untoward symptoms during the period of the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Signs and Symptoms of Gridhrasi (Sciatica) and VAS (Visual Analogue Scale)
SLR Test, Sicard Sign, Bragard test, Dehasyapravakrata (Scoliosis), Range of movement of hip joint by Goniometer |
1st, 11th, 27th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The research proposal titled An Open Label Single Arm Clinical Study to Evaluate the Efficacy of Koshtha Shodhana with Eranda Sneha Followed by Vaitarana Basti in Yogabasti Pattern in the Management of Gridhrasi (Sciatica). It aims to assess the therapeutic potential of classical Ayurvedic Panchakarma therapies in treating Gridhrasi, which correlates to sciatica in modern medicine. Sciatica, a prevalent and debilitating condition characterized by radiating pain from the lower back to the legs, affects up to 40% of the population and is linked to lifestyle factors such as prolonged sitting, poor posture, and mechanical strain. Modern treatments like NSAIDs and corticosteroids provide only temporary relief and often cause adverse effects, highlighting the need for holistic alternatives. In Ayurveda, Gridhrasi is classified under Nanatmaja Vata Vyadhi, primarily caused by vitiation of Vata (and sometimes Kapha). The classical management involves Snehana, Swedana, and Basti Karma, among which Basti is the prime therapy for Vata Vyadhi. This clinical study proposes an integrated Panchakarma protocol involving three days of Koshtha Shodhana (purgation) with Eranda Sneha (castor oil) followed by eight days of Yogabasti a combination of Vaitarana Niruha Basti and Sahachara Taila Matra Basti. A total of 30 patients aged 30–60 years will be selected from OPD/IPD based on diagnostic criteria for Gridhrasi. The study will assess improvements in pain, stiffness, pricking sensations, numbness, and functional mobility using both subjective and objective parameters such as VAS, SLR, Bragard, and Sicard tests. Statistical analysis will evaluate pre- and post-treatment outcomes. The expected result is significant symptom relief and functional improvement through Shodhana and Shamana actions, offering a safe, cost-effective, and root-cause-oriented management approach for Gridhrasi. |