| CTRI Number |
CTRI/2025/02/081067 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Physiotherapy (Not Including YOGA)
Other (Specify) [Randomised Comparative Clinical Study] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Combine Effect Of Panchakarma And Physiotherapy In knee osteoarthritis |
|
Scientific Title of Study
|
Comparative Clinical Study To Evaluate The Effect Of Atasi Upanaha With
Paraffin Wax Therapy And Atasi Upanaha Alone In Janusandhigat Vata. |
| 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 Kajal Arun Gajbhiye |
| Designation |
PG scholar |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalay |
| Address |
OPD No. 9 , Department Of Panchakarma,Shree Saptashrungi Ayurved Mahavidyalay Nashik
OPD No. 9 , Department Of Panchakarma,Shree Saptashrungi Ayurved Mahavidyalay Nashik
Nashik
MAHARASHTRA
4422003
India |
| Phone |
7798007662 |
| Fax |
|
| Email |
kajalgajbhiye012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjusha Sunil More |
| Designation |
HOD And Professor Department Of Panchakarma |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalay |
| Address |
OPD No.9 , Department Of Panchakarma,Shree Saptashrungi Ayurveda Mahavidyalay nashik
Nashik
MAHARASHTRA
4422003
India |
| Phone |
9422766836 |
| Fax |
|
| Email |
manjushasunilmore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjusha Sunil More |
| Designation |
HOD And Professor Department Of Panchakarma |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalay |
| Address |
OPD No.9 Department Of Panchakarma,Shree Saptashrungi Ayurveda Mahavidyalay nashik
Nashik
MAHARASHTRA
4422003
India |
| Phone |
9422766836 |
| Fax |
|
| Email |
manjushasunilmore@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD patients Of Department Of Panchakarma Shree Saptashrungi Ayurved mahavidyalay and Hospital Nashik , Maharashtra India 422003 |
|
|
Primary Sponsor
|
| Name |
Dr Kajal Arun Gajbhiye |
| Address |
Department Of Panchakarma,Shree Saptashrungi Ayurved Mahavidyalaya Nashik , Maharashtra,India 422003 |
| 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 Kajal Arun Gajbhiye |
Shree Saptashrungi Ayurved mahavidyalay and hospital nashik |
OPD no. 9 Department OF Panchakarma
Nashik
MAHARASHTRA |
7798007662
kajalgajbhiye012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M17||Osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | PHYSIOTHERAPY | DURATION OF PARAFFIN WAX THERAPY WILL BE FOR 20 MIN FOR 7 DAYS.
APPLICATION OF PARAFFIN WAX WILL BE DONE ON KNEE JOINT. IN GROUP C PARAFFIN WAX WILL BE APPLIED FIRST FOLLOWED BY ATASI UPANAHA . | | 2 | Intervention Arm | Procedure | - | upanAhasvedaH (sAgniH, उपनाहस्वेदः (साग्निः) | (Procedure Reference: : Sushrut chikitsa adhyay 32,, Procedure details: By giving seating position atasi upanaha will be applied over affected knee joint & covered with erand patra & cotton cloth.Upanaha will be kept for 1 hour .Duration of procedure for 7 days. first follow up will be after 7 days , second follow up on 14th day.Bandage will be removed after 1 hour & part will be clean with lukewarm water.)
(1) Medicine Name: Atasi godhum yava saindhav murchit til tail takra erand patra, Reference: Dravyaguna vidyan acharya yadavji trikamji, Route: Topical, Dosage Form: Lepa Churna, Dose: 250(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 30 to 65 years
2. Patients having classical signs & symptoms of janusandhigata vata
3. Both gender Male & Female.
4. Patients who are indicated for swedana karma and physiotherapy
5. Patients who will give written consent |
|
| ExclusionCriteria |
| Details |
1. Patients of age below 30 years & more than 65 Years.
2. Patients using any other systemic drugs which may alter the result.
3. Patients who are contraindicated for swedan karma and physiotherapy.
4. Patients having congenital structural deformities.
5. Patients with other joint deformities or disease which are not releated to
janusandhigata vata.
6. Patients with other systemic disorder and serious illness. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Integrative treatment that is atasi upanah with wax therapy would be more beneficial than individual treatment |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know which treatment modality is most effective to relives specific symptoms of janusandhigata vata. |
14 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| 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="8"
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
|
Many local swedan therapies are done routinely in Panchakarma procedures like Sankar Swed, Sthanik basti , Lepa etc. Upanaha sweda is one of the swedan modality having remarkable results in various conditions of Janusandhigat vata. Paraffin wax therapy is one of the effective thermal modality routinely used in physiotherapy for joint pain, stiffness and to improve joint range of motion. A lot of Independant research has been done i.e. Effect of Atasi Upanah in Janusandhigat vata. Effect of Paraffin wax therapy in Janusandhigat vata .but combined research study of both treatment modalities not found. So to enhance patient centric approach, and to save the time of patients both the therapies will conduct together. It will enhance rehabilitation for chronic condition. Also this approach will lead to more comprehensive and long lasting result.
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