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CTRI Number  CTRI/2022/04/041630 [Registered on: 04/04/2022] Trial Registered Prospectively
Last Modified On: 03/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effectiveness of Yavagodhumadi Upanaha Swedana in comperison to Koladi Upanaha Swedana and 1% topical Diclofenac gel in Janu Sandhigatavata (Osteoarthritis of knee) 
Scientific Title of Study   Evaluation of comparative clinical efficacy of Yavagodhumadi Upanaha Swedana, Koladi Upanaha Swedana and 1% topical Diclofenac sodium gel in the management of Janu Sandhigatavata (Osteoarthritis of knee) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr ABHISHEK BHATTACHARJEE 
Designation  Lecturer 
Affiliation  North Eastern Institute of Ayurveda & Homoeopathy, Shillong  
Address  Department of Panchakarma, College of Ayurveda, NEIAH, Mawdiangdiang, Shillong, Meghalaya

East Khasi Hills
MEGHALAYA
793018
India 
Phone  8876059293  
Fax    
Email  drabhishekb@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shweta Parwe 
Designation  Professor & Head 
Affiliation  Mahatma Gandhi Ayurveda College, Hospital & Research Centre 
Address  Department of Panchakarma, Mahatma Gandhi Ayurveda College, Hospital & Research Centre, Salod, Wardha, Maharashtra

Wardha
MAHARASHTRA
442001
India 
Phone  9511659185  
Fax    
Email  drshwetaparve@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr ABHISHEK BHATTACHARJEE 
Designation  Lecturer 
Affiliation  North Eastern Institute of Ayurveda & Homoeopathy, Shillong  
Address  Department of Panchakarma, College of Ayurveda, NEIAH, Mawdiangdiang, Shillong, Meghalaya

East Khasi Hills
MEGHALAYA
793018
India 
Phone  8876059293  
Fax    
Email  drabhishekb@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Ayurveda College, Hospital and Research Centre, Salod, Wardha, Maharashtra.  
 
Primary Sponsor  
Name  Abhishek Bhattacharjee 
Address  Department of Panchakarma College of Ayurveda NEIAH Mawdiangdiang Shillong Meghalaya 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shweta Parwe Prof Head Dept of Panchakarma MGACHRC Wardha  Mahatma Gandhi Ayurved College, Hospital and Research Centre  Departrment of Panchakarma, MGACH & RC, Salod, Wardha, Maharashtra, India.
Wardha
MAHARASHTRA 		 9511659185

drshwetaparve@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MGACH & RC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-1% Topical Diclofenac Sodium Gel1% Topical Diclofenac Sodium Gel will be applied over the effected knee/knees twice daily.
2Intervention ArmProcedure-Yavagodhumadi Upanaha Swedana (Procedure Reference: Sushruta. Chikitsa. 32: 12, Procedure details: Yavagodhumadi Upanaha will be prepared using Godhuma Churna, Yava Churna, Dhanyamla, Tila Taila, Kinva and Saindhava Lavana. Upanaha will be applied as per classical procedure. )
(1) Medicine Name: Yavagodhumadi Upanaha, Reference: Charaka samhita.Sutrasthan.14:35, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 100(g), Frequency: hs, Duration: 14 Days
3Comparator ArmProcedure-Koladi Upanaha Swedana (Procedure Reference: Sushrut. Chikitsa. 32: 12, Procedure details: Koladi Upanaha is prepared with Kola, Kulattha, Devadaru, Rsna, Masha, Atasi, Tila, Kustha, Vacha, Shatapushpa, Yava, Tila Taila, Saindhava and Kanji. Upanaha will be applied as per classical procedure. )
(1) Medicine Name: Koladi Upanaha , Reference: Charakasamhita. Sutrasthana.3:18, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 100(g), Frequency: hs, Duration: 14 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient who are willing to participate in the study and ready to give a written informed consent.
2.Subjects of either sex in the age group of 40 to 60 years.
3.Patients with a diagnosis of knee Osteoarthritis as per American College of Rheumatology clinical and radiographic criteria.
4.Knee Osteoarthritis confirmed by radiological changes as per Kellgren & Lawrence radiological scale of at least grade 2 in X-ray.
5.Osteoarthritis Patients with mean baseline pain intensity of 4 in Visual Analogue Scale (VAS) of 10 in one or both knees.
 
 
ExclusionCriteria 
Details  1.The subjects who are known to have congenital dysplasia, gouty arthritis, rheumatoid arthritis, psoriatic arthritis and other autoimmune diseases, malignancies, history of any trauma or fractured joint or surgical history to the joint.
2.Patients with gross disability in performing daily normal routine i.e., bedridden subjects or confined to a wheelchair, having any deformity of knee, hip or back altering the gait and posture.
3.Patient who has been administered any chondroprotective drugs, intra-articular injection into the affected knee joint or invasive measures have been performed at the affected joint or systemic medication with corticosteroids during the preceding 3 months.
4.Patients on medication likely to influence evaluation.
5.Pregnant or lactating women
6.Patients with an acute mental disorder, a serious acute organic disease, or any serious comorbidity that made it impossible to participate in the trial interventions.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
WOMAC questionnaire for pain and physical function  0- day, 15th day, 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
1. Visual analogue scale (VAS) score for pain and stiffness.
3. 30 (thirty) second chair stand test
4. 40 (forty) meter (4x10 meter) fast-paced walk test
5. Timed up and go test
6. 6 (six) minute walk test
7. Stair climb test
8. Goniometric measurement of the range of movement of knee joint
9. Knee circumference
 		 0- day, 15th day, 30th day 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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)   11/04/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  no

  6. For how long will this data be available start date provided 27-05-2025 and end date provided 27-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - no
Brief Summary  
Sandhigatavata is the commonest type of joint disorder seen in clinical practice and the incidence increases with aging due to Dhatu Kshaya and Vata Vriddhi. The similar condition in modern contemporary system of medicine has been termed as Osteoarthritis. It is the commonest cause of locomotor disability specially in the elderly population and is the result of aging, trauma and bio-mechanical stress over the joint leading to loss of articular cartilage. Different internal medications as well as external therapies has been mentioned in different Ayurvedic classical texts for this condition. Upanaha which is said to be the best Swedana procedure for Vataja disorders has also been mentioned as one of the best external therapies for Sandhigatavata. The present research work is planned to evaluate the clinical efficacy of Yavagodhumadi Upanaha Swedana in managing the pain of Janu Sandhigatavata (Osteoarthritis of knee). As Koladi Upanaha has been found effective in the management of Janu Sandhigatavata in different clinical trials, so the efficacy of Yavagodhumadi Upanaha will be compared with Koladi Upanaha. Again 1% topical Diclofenac gel has been found to be effective in the management of pain of knee osteoarthritis, improves physical function so considered as one of the first line management for osteoarthritis of knee. Seeing these it also has been taken as a control drug to compare the efficacy of Yavagodhumadi Upanaha. So, in the present study the effectiveness of Yavagodhumadi swedana will be compared with Koladi upanaha swedana and 1% topical Diclofenac sodium gel in the management of Janusandhigata vata. The present study is a randomized, researcher blind three arm interventional comparative clinical trial of 30 days duration where 70 patients will be allocated in each group (total 210 patients in 3 groups) following inclusion and exclusion criteria. In this study the effectiveness of an Ayurvedic external therapy (Yavagodhumadi Upanaha Swedana) will be compared to a similar therapy (Koladi Upanaha Swedana) and 1% topical Diclofenac sodium gel for superior effectiveness. Evaluation assessments will be done at base line (0-day), 15th day and 30th day (completion). Assessment will be done based on standard subjective and objective parameters. Result will be analyzed statistically. 
 
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