| CTRI Number |
CTRI/2025/01/079189 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of application of Myostaal liniment as add on in strenthening muscles in knee arthritis.
|
|
Scientific Title of Study
|
Myostaal Liniment Application as Add-on Therapy for Muscle Strengthening in Participants Suffering from Knee Osteoarthritis:
An open-label, Randomized Clinical Study
|
| 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 Asmita Wele |
| Designation |
Professor and Research Director |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune |
| Address |
Research Director Cabin
Ground Floor Room no 1
Dr D Y Patil College of Ayurved & Research Centre Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9923356086 |
| Fax |
|
| Email |
asmita.wele@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jibi Varghese |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune |
| Address |
Department of Kayachikitsa
3rd Floor
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8983478062 |
| Fax |
|
| Email |
vjayu82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjivani Kamble |
| Designation |
Associate Professor |
| Affiliation |
Dr D Y Patil College of Physiotherapy Pimpri Pune |
| Address |
Department of Physiotherapy
3rd Floor
Dr D Y Patil College of Physiotherapy Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9860117191 |
| Fax |
|
| Email |
sanjivani.dhote@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Solumiks Herbaceuticals Limited
Nanubhai Desai Road Khetwadi
Mumbai 400004 |
|
|
Primary Sponsor
|
| Name |
Solumiks Herbaceuticals Limited |
| Address |
135, Nanubhai Desai Rd, Charni Road East, Khetwadi, Girgaon, Mumbai, Maharashtra 400004 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jibi Varghese |
Dr. D.Y.Patil College of Ayurved Hospital |
Department of Kayachikitsa
3rd floor
Pune
MAHARASHTRA |
8983478062
vjayu82@gmail.com |
| Dr Sanjivani Kamble |
Dr. D.Y.Patil College of Physiotherapy |
Department of Physiotherapy
Pune
MAHARASHTRA |
9860117191
sanjivani.dhote@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 | Intervention Arm | Procedure | - | tailam | (Procedure Reference: none, Procedure details: Myostaal Liniment application on both knees twice a day followed by pre-decided physiotherapy regimen in the morning & evening 5 repetitions of each of the exercise)
(1) Medicine Name: Myostaal Liniment, Reference: Proprietary, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Duration: 60 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Physiotherapy | Pre decided set of physiotherapy exercises in the morning and evening 5 repetitions of each of the exercise |
|
|
|
Inclusion Criteria
|
| Age From |
38.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of Idiopathic Knee Osteoarthritis (unilateral) for minimum 1 month and maximum 5 years according to the clinical guidelines of the American College of Rheumatology.
2. Patient with a previous history of no treatment or only conservative treatment.
3. Patient having baseline knee joint pain more than 4 on NPRS Scale either at rest or on weightbearing activities (e.g., walking, standing, climbing staircase) during the preceding 24 hours.
4. Patient who have Grades 1 and 2 in radiological findings based on Kellgren and Lawrence system for classification of osteoarthritis.
5. Patient willing to give written informed consent and willing to come for follow-up visits. |
|
| ExclusionCriteria |
| Details |
1. Participant with secondary arthritis or systemic inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, postinfection arthritis, metabolic arthritis, traumatic arthritis, or surgical joint replacement)
2. Participants on NSAIDs and Corticosteroids (Topical corticosteroid application in last 14 days, Oral corticosteroid in last 14 days, intramuscular corticosteroid in last 30 days, intraarticular corticosteroid into the knee in last 90 days, intraarticular corticosteroid in any other joints in last 30 days); or participant requiring systemic corticosteroid during the study course.
3. Participant with a history of surgery or planning for surgery in the next 3 months.
4. Participant with knee replacement surgery and knee arthroscopy in the past 2 years.
5. Participant with intra-articular viscosupplementation (e.g., SynviscR) in affected knee joint in the past 6 months.
6. The participant with ongoing use of oral muscle relaxant or low-dose antidepressant medication for chronic pain management.
7. Participants with auto-immune disease, uncontrolled hypertension, uncontrolled diabetes mellitus (requiring a change in antidiabetic therapy or insulin injections), and chronic severe respiratory disease.
8. The participant with a history of clinically active renal, hepatic, and peptic ulcer disease.
9. Participant with a history of life-threatening cardiovascular and/or neurological events in the past 1 year.
10. The participant with a history of alcohol or drug abuse, or bleeding disorder.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in knee muscle strength by Push-pull Dynamometer |
at baseline and at the end of 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the change in WOMAC Index on WOMAC (Modified-CRD Pune version) from baseline to Day 60 with Myostaal Liniment application as an add-on to physiotherapy as compared to physiotherapy alone in participants suffering from Knee Osteoarthritis.
2. To evaluate the change in distance covered in Six-Minute Walk Test (6MWT)
3. To evaluate the change in Single Leg Stance Test
4. To compare the number of participants showing adverse events if any.
|
at baseline and at the end of 60 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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="6"
Days="11" |
|
Recruitment Status of Trial (Global)
|
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
|
Knee Osteoarthritis (OA) contributes to nearly 80 % of Global OA burden. Knee OA is estimated to affect 3.9% of rural Indians and 5.5% of urban Indians. The initiation , progression and severity of Knee OA have been associated with decreased muscular strength and alteration in joint biomechanics. excercises to strengthen the knee are a crucial part of the treatment to avoid surgery and maintain joint mobility. This present study is designed to evaluate the muscle stengthening effect of Myostaal Liniment application as an add on physiotherapy as compared to physiotherapy alone in patients suffering from Knee Osteoarthritis. |