| CTRI Number |
CTRI/2026/03/105795 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Upanaha (external)] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effectiveness of two different herbal leaf poultices in reducing pain for patients with knee osteoarthiritis. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of shigru patra upanaha and nirgundi patra upanaha in the management of janu sandhigata vata (osteoarthritis of knee) |
| 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 T Gourav Kumar |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
23VF G5G Department of pancakarma Sri Jayendra Saraswathi Ayurveda College And Hospital
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
8637678706 |
| Fax |
|
| Email |
dcajikumar98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitta Ranjan Das |
| Designation |
Principal Head of the department and Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
23VF G5G Department of pancakarma Sri Jayendra Saraswathi Ayurveda College And Hospital
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9444123506 |
| Fax |
|
| Email |
drcrdayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Gourav Kumar |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
23VF G5G Department of pancakarma Sri Jayendra Saraswathi Ayurveda College And Hospital
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
8637678706 |
| Fax |
|
| Email |
dcajikumar98@gmail.com |
|
|
Source of Monetary or Material Support
|
| 23 VF G5G Department of pancakarma Sri Jayendra Saraswathi Ayurveda College And Hospital |
|
|
Primary Sponsor
|
| Name |
Dr T Gourav Kumar |
| Address |
23 VF G5G Department of pancakarma Sri Jayendra Saraswathi Ayurveda College And Hospital |
| 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 T Gourav Kumar |
Sri Jayendra Saraswathi Ayurveda College And Hospital |
23 VF G5G Department of pancakarma Sri Jayendra Saraswathi Ayurveda College And Hospital
Thiruvallur
TAMIL NADU |
8637678706
dcajikumar98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Sri Jayendra Saraswathi Ayurvdea college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M171||Unilateral primary osteoarthritisof knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | upanAhasvedaH (sAgniH, उपनाहस्वेदः (साग्निः) | (Procedure Reference: Susruta samhita, Procedure details: The upanaha dravya is mixed well made as a paste and applied over the affected knee.)
(1) Medicine Name: Nirgundi patra churna, Reference: Bhavaprakasha nighantu, Route: Topical, Dosage Form: Churna/ Powder, Dose: 100(g), Frequency: bd, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | upanAhasvedaH (sAgniH, उपनाहस्वेदः (साग्निः) | (Procedure Reference: Susruta samhita, Procedure details: The upanaha dravya is mixed well made as a paste and applied over the affected knee.)
(1) Medicine Name: Shigru patra churna, Reference: Kaiyadeva nighantu, Route: Topical, Dosage Form: Churna/ Powder, Dose: 100(g), Frequency: bd, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient diagnosed as janu sandhigata vata, signs and symptoms mentioned in ayurvedic classics.
2. Acute (from 1 week to 4 weeks) and Sub acute (from 4 weeks to 3 months) cases.
3. Patients in the BMI range from 18.5 – 24.9
4.Patients confirmed by X-Ray (According to Kellgren Lawrence Scale for Osteoarthritis up to Grade 1 and Grade 2).
|
|
| ExclusionCriteria |
| Details |
1. Patient not in the age limit.
2. Patient with Grade 3 and Grade 4 in the affected knee (According to Kellgren Lawrence Scale).
3. Congenital anatomical abnormality of knee and surrounding structures.
4. Patients in the BMI range 25.0 and above.
5. Patients with pre-diagnosed thyroid infection.
6.Associated with sports injuries or trauma.
7.Patients with open wound or surgery on the site of administration.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the comparative effectiveness of shigru patra upanaha and nirgundi patra upanaha in the management of Janu sandhigata vata using WOMAC score and Goniometer. |
Assessment will be done on 8th day and 14th 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/04/2026 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Globally osteoarthritis which is commonly corelated to Janu Sandhigata Vata affects over 17 to 60 percent of Indians depending on region with symptomatic knee OA rising significantly women are more affected 20 to 41 percent. Ayurveda as per Acharya Sushruta recommends classical Bahya parimarjana Chikitsa especially Snehana Upanaha Bandhana for the management of Janu Sandhigata Vata. Upanaha a localized fomentation therapy involves applying a warm herbal infused paste to the affected knee joint which is then wrapped and left in place for 12 hours. This method delivers sustained heat and therapeutic effects directly to the site of pathology. In classical Dravyaguna terms Sigru and Nirgundi these are inherently Usna virya Shothahara and Shoolahara making them especially appropriate for pacifying deranged Vata Kapha in the knee joint. Despite clinical evidence supporting various Upanaha formulations such as Grihadhumadi and Mustadi churnas in alleviating symptoms of Janu Sandhigata Vata through randomized trials the contemporary clinical evidence on Sigru and Nirgundi patra Upanaha in Janu Sandhigata Vata is lacking. The core aim is to determine which leaf imparts superior symptomatic relief particularly in terms of pain reduction and swelling resolution while contributing to the broader evidence base of Ayurvedic Panchakarma interventions. This study addresses a significant empirical gap and supports advancement in scholarly understanding of classical Ayurvedic external therapies for degenerative knee joint disease. |