| CTRI Number |
CTRI/2026/02/104119 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Traditional Herbal Poultice and a New Herbal Patch for Reducing Knee Pain and Stiffness in Patients with Knee Osteoarthritis |
|
Scientific Title of Study
|
Randomized Comparative Clinical Study To Evaluate The Effect Of Classical Preparation Of Upanaha Sweda And Upanaha Patch Using Swedopaga Gana In The Management Of Janusandhigata Vata W.S.R. To Osteoarthritis Of Knee Joint. |
| 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 Gursimranjeet Singh |
| Designation |
Post Graduate Scholar |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Panchakarma
Parul Institute of Ayurved and Research
Parul University
PO Limda Taluka Waghodia District Vadodara 391760
Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8195800502 |
| Fax |
|
| Email |
gursimransinghjohal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya B |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Panchakarma
Parul Institute of Ayurved and Research
Parul University
PO Limda Taluka Waghodia District Vadodara 391760
Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9844810958 |
| Fax |
|
| Email |
dr.divyadeva3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gursimranjeet Singh |
| Designation |
Post Graduate Scholar |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Panchakarma
Parul Institute of Ayurved and Research
Parul University
PO Limda Taluka Waghodia District Vadodara 391760
Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8195800502 |
| Fax |
|
| Email |
gursimransinghjohal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma
Parul Institute of Ayurved and Research
Parul University
PO Limda Taluka Waghodia District Vadodara 391760
Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Gursimranjeet Singh |
| Address |
Department of Panchakarma
Parul Institute of Ayurved and Research
Parul University
PO Limda Taluka Waghodia District Vadodara 391760
Gujarat |
| 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 Gursimranjeet Singh |
Khemdas Hospital |
OPD No. 7, Ground Floor,
Department of Panchakarma,
Khemdas Hospital,
Parul Institute of Ayurved and Research,
Parul University,
PO Limda Taluka Waghodia District Vadodara 391760
Gujarat
Vadodara
GUJARAT |
8195800502
gursimransinghjohal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee IEC-PIAR HR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. 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: Sushruta Samhita Chikitsa Sthana Chapter 4/14, Procedure details: 150 g of Swedopaga Upanaha Choorna mixed with Moorchita Tila Taila, Kanji, Saindhava and 40 g of Godhuma. The mixture is made into a smooth, semi-solid paste. Patient is positioned comfortably (supine or sitting) with the knee joint exposed. Sthanik Abhyanga with Moorcchita Tila Taila is performed on the affected joint. The warmed paste is applied over the affected Janusandhi and covered with Eranda Patra. Bandaging is done using Khora cloth to secure the application. The Upanaha is retained for 12 hours. After removal of the paste, the body part will be washed with warm water.
)
(1) Medicine Name: Swedopaga Gana, Reference: Charaka Samhita Sutrasthana Chapter 4/13, Route: Topical, Dosage Form: Lepa Churna, Dose: 150(g), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | upanAhasvedaH (sAgniH, उपनाहस्वेदः (साग्निः) | (Procedure Reference: Sushruta Samhita Chikitsa Sthana Chapter 4/14, Procedure details: Patient is positioned in supine or sitting posture with the affected knee joint exposed. Sthanik Abhyanga with Moorchita Tila Taila is performed on the joint. The ready-made Upanaha Patch prepared using Swedopaga Gana is applied over the affected knee joint. Patch is retained in place for 12 hours. After 12 hours, the patch is gently removed.
)
(1) Medicine Name: Swedopaga Gana, Reference: Charaka Samhita Sutrasthana Chapter 4/13, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(NA), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient fulfilling the signs and symptoms of Janusandhigata Vata of mild grade.
2.Patient of all socio-economic group.
3.Patient who is willing to give written consent.
4.Patient suitable for swedana karma
|
|
| ExclusionCriteria |
| Details |
1.Patient having severe systemic illnesses like uncontrolled Hypertension, Diabetes Mellitus.
2.Patient having other joint diseases like Psoriatic Arthritis, Gout Arthritis and Rheumatoid Arthritis.
3.Patient with Pregnancy and lactation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain and stiffness (VAS, KOOS). IPR value of method of preparartion of ready made Upanaha Patch. |
Before Treatment - 0th Day
Between Treatment- 4th Day
After Treatment - 8th Day
Follow Up - 14th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in mobility (ROM) and patient satisfaction. |
Before Treatment - 0th Day
Between Treatment- 4th Day
After Treatment - 8th Day
Follow Up - 14th Day
|
|
|
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)
|
02/03/2026 |
| 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="0"
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
|
This is a randomized, open-label, two-arm comparative clinical trial evaluating the efficacy of classical Upanaha Sweda versus a novel Upanaha Patch, both prepared using Swedopaga Gana herbs as per Charaka Samhita in managing Janusandhigata Vata with reference to Osteoarthritis of Knee Joint. Sixty participants aged 18-60 years with mild to moderate symptoms will be recruited from the OPD/IPD of Parul Institute of Ayurved and Research, Vadodara and randomized into two groups of 30 each. Group A receives classical Upanaha Sweda (herbal paste applied warm, covered with Eranda Patra, bandaged for 12 hours daily) for 7 days, while Group B receives the ready to use Upanaha Patch (standardized transdermal formulation with the same herbs, heated over steam and applied for 12 hours daily) for 7 days. Both include prior local Abhyanga with Moorchita Tila Taila. Assessments occur at baseline (Day 0), mid-treatment (Day 4), post-treatment (Day 8) and follow-up (Day 14), measuring primary outcomes of pain and stiffness reduction via VAS and KOOS scores and secondary outcomes including range of motion (goniometer), patient satisfaction, compliance, ease of application and adverse effects. The study aims to determine if the innovative patch offers comparable therapeutic benefits with improved practicality, patient comfort and standardization over the classical method. This ready to use Upanaha Patch also have IPR values in regards to the method of preparation with swedopaga gana dravyas. |