| CTRI Number |
CTRI/2025/09/094696 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see effect of Shampakadi Basti and Tikta Ksheera Basti in Sandhigata Vata(Osteoarthritis) |
|
Scientific Title of Study
|
Comparative Clinical Evaluation Of Shampakadi Basti And Tikta Ksheera Basti In Sandhigata Vata(Osteoarthritis) |
| 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 Ayutansh Dobhal |
| Designation |
PG Scholar Panchakarma |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar |
| Address |
Panchakarma Department OPD No. 4 Patanjali Ayurveda Hospital
Patanjali Yogpeeth Phase 1, Roorkee Road, Haridwar, Uttaranchal
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9411184075 |
| Fax |
|
| Email |
santydobhal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Ketan Mahajan |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar |
| Address |
Panchakarma Department OPD No. 4 Patanjali Ayurveda Hospital
Patanjali Yogpeeth Phase 1, Roorkee Road, Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8979793731 |
| Fax |
|
| Email |
ketanmahajan82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayutansh Dobhal |
| Designation |
PG Scholar Panchakarma |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar |
| Address |
Panchakarma Department OPD No. 4 Patanjali Ayurveda Hospital
Patanjali Yogpeeth Phase 1, Roorkee Road, Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9411184075 |
| Fax |
|
| Email |
santydobhal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Patanjali Yogpeeth Haridwar, India 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar |
| Address |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Patanjali Yogpeeth Phase 1, Roorkee Road, Haridwar, Uttaranchal 249405 India |
| Type of Sponsor |
Private medical college |
|
|
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 Ayutansh Dobhal |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar |
Department Panchakarma OPD No 4 Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar
Hardwar
UTTARANCHAL |
9411184075
santydobhal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patanjali Ayurveda College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M150||Primary generalized (osteo)arthritis. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka Samhita Sutra Sthan 28/27, Procedure details: Procedure Details: Niruha Basti
Poorva Karma: After passing feaces, urine and flatus; the patient on empty stomach should be prepared with Abhyanga and Swedana. However patient should not be very hungry.
Pradhan Karma: Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form of pillow while keeping the body straight and relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus and enema nozzle will be lubricated with oil. After removing air bubbles, appropriate quantity of prepared Niruha Basti will be administered.
Paschat Karma: Patient will be advised to lie on his back i.e., in supine position comfortably on bed. Patient will be advised to empty his bowel after getting urge of defecation.
Anuvasana Basti:
Poorva Karma: Patient will be given Abhyanga and Swedana followed with warm water bath and then patient will be advised to take food less by ¼th of usual quantity. Ask him to eliminate feaces, urine or flatus if present.
Pradhan Karma: Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form of pillow while keeping the body straight and relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus and enema nozzle will be lubricated with oil. After removing air bubbles appropriate quantity of prepared Anuvasana Basti will be administered.
Paschat Karma: Buttocks of the patient will be patted with palms for 3 times and will be advised to relax in supine position. Patient will be advised to empty his bowel after getting urge for defecation.)
(1) Medicine Name: Tikta Ksheera Basti , Reference: Charaka Samhita Sutra Sthan 28/27, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 576(ml), Frequency: od, Duration: 9 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Susruta Samhita Chikitsa Sthan 38/43-46, Procedure details: Procedure Details: Niruha Basti
Poorva Karma: After passing feaces, urine and flatus; the patient on empty stomach should be prepared with Abhyanga and Swedana. However patient should not be very hungry.
Pradhan Karma: Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form of pillow while keeping the body straight and relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus and enema nozzle will be lubricated with oil. After removing air bubbles, appropriate quantity of prepared Niruha Basti will be administered.
Paschat Karma: Patient will be advised to lie on his back i.e., in supine position comfortably on bed. Patient will be advised to empty his bowel after getting urge of defecation.
Anuvasana Basti:
Poorva Karma: Patient will be given Abhyanga and Swedana followed with warm water bath and then patient will be advised to take food less by ¼th of usual quantity. Ask him to eliminate feaces, urine or flatus if present.
Pradhan Karma: Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form of pillow while keeping the body straight and relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus and enema nozzle will be lubricated with oil. After removing air bubbles appropriate quantity of prepared Anuvasana Basti will be administered.
Paschat Karma: Buttocks of the patient will be patted with palms for 3 times and will be advised to relax in supine position. Patient will be advised to empty his bowel after getting urge for defecation.)
(1) Medicine Name: Shampakadi Basti , Reference: Susruta Samhita Chikitsa Sthan 38/43-46, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 576(ml), Frequency: od, Duration: 9 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients are willing to participate in the study and provide informed consent.
Patients are willing to comply with the treatment regimen and follow-up visits.
Patient with Radiological finding of Osteoarthritis.
Patients with mild to moderate severity of Sandhigata Vata symptoms. |
|
| ExclusionCriteria |
| Details |
Patients with other serious medical conditions such as cancer, severe cardiovascular disease, or uncontrolled diabetes.
Patients unfit for Basti
Pregnant or lactating women.
Patients with contraindications to Basti therapy such as recent abdominal surgery.
Patients with Major Psychiatric Disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sandhi Shoola (Joint Pain)
Sandhi Stambha (Joint Stiffness)
Sandhi Shotha (Joint Swelling)
Sandhi Atopa (Crepitus)
Sandhi Sparsha Akshamatva (Tenderness in Joint)
Sandhi Gati Asamarthatha (Restriction in Range of Joint Movements) |
9,30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Joint deformity
Immobility or restricted movement of joints
Asthi Shithilata (bone laxity)
Peshi Kshaya (muscle wasting)
Sandhi Vishlesha (joint dislocation or damage)
Loss of joint function
Degeneration of joint structures
Disability especially in weight-bearing joints |
9,30days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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
|
This study is a Comparative Clinical Evaluation of Shampakadi Basti and Tikta Ksheera Basti schedule in Sandhigata Vata(Osteoarthritis)
This will be conducted on 60 randomly selected patients from OPD/IPD of Panchakarma Department of Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar. Patient will be divided into 2 groups- 30 patients will be administered Shampakadi Basti and 30 patients will be administered Tikta Ksheera Basti in Modified Kala Basti schedule. Follow up will be taken after 1 month assessment to be done on the basis of subjective and objective parameters as discussed earlier. |