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CTRI Number  CTRI/2021/06/033930 [Registered on: 01/06/2021] Trial Registered Prospectively
Last Modified On: 01/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To evaluate the effect of Myostaal liniment local application for muscle strengthening in patients suffering from osteoarthritis of knee 
Scientific Title of Study   A prospective, randomized, observer blind, comparative, parallel, 2-arm study to evaluate the efficacy and safety of a Myostaal liniment application as addon therapy for muscle strengthening in participant suffering from osteoarthritis of knee 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Version 01 dated on 26.03.2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahesh Kumar Harit 
Designation  Dean and Professor 
Affiliation  D.Y. Patil Deemed to be University School of Ayurveda 
Address  D. Y. Patil Ayurvedic Hospital, Special OPD - for clinical trials, First Floor, D.Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai-400706
Dept of Sanskrit Samhita Siddhant, D.Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai-400706
Thane
MAHARASHTRA
400 706
India 
Phone  9322217607  
Fax    
Email  maheshkumar.harit@dypatil.edu  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Vedvati Ketan Bhapkar 
Designation  Assistant Professor 
Affiliation  D.Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai-400706 
Address  D. Y. Patil Ayurvedic Hospital, Special OPD - for Clinical Trials, First Floor, D.Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai-400706
D. Y. Patil Ayurvedic Hospital, Special OPD - for Clinical Trials, First Floor, D.Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai-400706
Thane
MAHARASHTRA
400 706
India 
Phone  9594830100  
Fax    
Email  drvedvati@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vinay Pawar 
Designation  Associate Professor 
Affiliation  D.Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai-400706 
Address  D. Y. Patil Ayurvedic Hospital, Special OPD - for Clinical Trials, First Floor, D.Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai-400706
1/3, Ganesh Kripa Sadan, Meghwadi, Jogeshwari (East), Mumbai - 400 060
Mumbai
MAHARASHTRA
400 706
India 
Phone  7506631982  
Fax    
Email  vinay.pawar@dypatil.edu  
 
Source of Monetary or Material Support  
Solumiks Herbaceuticals Limited, 135, Nanubhai Desai Road, Khetwadi, Girgaon, Mumbai- 400 004.  
 
Primary Sponsor  
Name  Solumiks Herbaceuticals Limited  
Address  135, Nanubhai Desai Road, Khetwadi, Girgaon, Mumbai- 400 004. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Mahesh Kumar Harit  D. Y. Patil Ayurvedic Hospital - Special OPD for Clinical Trials -   D. Y. Patil Ayurvedic Hospital, Special OPD - For Clinical Trials, First Floor, D. Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai
Thane
MAHARASHTRA 
9322217607

maheshkumar.harit@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, D. Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai  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  
Type  Name  Details 
Intervention  Myostaal Liniment  5 ml of Liniment twice a day along with physiotherapy twice a day for 90 days 
Comparator Agent  Physiotherapy  physiotherapy twice a day for 90 days 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Diagnosed case of Idiopathic knee osteoarthritis for minimum 1month and maximum 5 years according to clinical guidelines of
American college of Rheumatology. The guidelines include patient
currently experiencing pain in one or both the knees with at least 3
out of the following 6 features:
- Age 40 – 70 years
- Morning stiffness within 30 minutes of walking
- Crepitus
- Bony tenderness
- Bony enlargement
- No palpable warmth
3. Participant having baseline knee joint pain more than 40 mm on Visual Analogue Scale (VAS) either at rest or on weight bearing activities (e.g., walking, standing, climbing staircase) during the preceding 24 hours.
4.Participants willing to give written informed consent.
5. Participants willing to follow up. 
 
ExclusionCriteria 
Details  1. Participants with secondary arthritis related to systemic inflammatory
arthritis (including rheumatoid arthritis, psoriatic arthritis, postinfectious arthritis and metabolic arthritis, traumatic arthritis or
surgical joint replacement)
2. Participants on corticosteroid use: (a) oral corticosteroid within the
previous 14 days, or (b) intramuscular corticosteroid within 30 days,
or (c) intra-articular corticosteroid into the study knee within 90 days, or (d) intra-articular corticosteroid into any other joint within 30 days, or (e) topical corticosteroid at the site of application within 14 days; Or patient requiring systemic corticosteroids during the course of study.
3. Participants on NSAIDS use will be excluded.
4. Participants who has undergone or who is planning to undergo surgery in next 3 months will be excluded from the study
5. Participants who has underwent knee replacement surgery for the
affected knee and who have undergone a knee arthroscopy within
past 2 years. Also, Patient with intra-articular visco supplementation
(e.g., SynviscR) in the affected knee joint in the preceding 6 months
6. Participants with on-going use of medication including oral muscle
relaxants, or low-dose antidepressant for any chronic pain
management
7. Participants with auto-immune disease, uncontrolled hypertension,
Diabetes mellitus requiring insulin injections and chronic severe
respiratory disease.
8. Participants with history of clinically-active renal, hepatic or peptic ulcer disease
9. History of life threatening cardiovascular and /or neurological event in the past one year.
10. Participants with history of alcohol or drug abuse, bleeding disorder
11. Participants having any severe active infectious disease requiring
hospitalization.
12. Pregnancy or lactation.
13. Participants who has taken any herbal medication in the past 4 weeks.
14. Participants with history of severe allergy or anaphylactic reaction.
15. Participants participating in another investigational drug trial in the
previous 30 days.
16. Participants who cannot give valid consent such as mentally retarded, unconscious patients and psychiatric illness
17. Known history of positive screening result for hepatitis B and/or
Hepatitis C virus.
18. History of HIV or any immune deficient conditions
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy in terms of Force generation (strength of muscle) with the help of a push-pull dynamometer Baseline to day 90 with Myostaal liniment application along with physiotherapy in participants suffering from knee joint osteoarthritis incomparison to only physiotherapy given group  Day0 Day15 Day30 Day60 Day90 
 
Secondary Outcome  
Outcome  TimePoints 
A) Push-pull leg dynamometer
B) WOMAC functional subscale sore
C) Distance assessment in 6 Minutes’ Walk Test
D) Time assessment in Single Leg Stand Test
E) Pain intensity Visual Analogue Scale
F) Lequesne severity index score
G) Muscle strength assessment in 5 Times sit to stand test (FTSST 
Day0 Day15 Day30 Day60 Day90 
 
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 3 
Date of First Enrollment (India)   10/06/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

A prospective, active-controlled, randomized, observer blind,comparative, parallel, 2-arm study will be conducted on 60 participants suffering from osteoarthritis of knee evaluate the efficacy and safety of a Myostaal liniment application.

Participant attending Orthopaedics OPD with a history of osteoarthritis knee and referred to physiotherapy OPD for physiotherapy, satisfying the selection criteria will be selected. All participants who voluntarily agree to participate and provide written informed consent for participation will be recruited in the study. Detailed personal, present and past medical history will be taken. Thorough physical examination, which includes vital variables, systemic examination, weight and demographics will be recorded and this will be called as a screening visit. Once the laboratory blood investigational reports satisfying the inclusion criteria are met, then these participants will be randomized into 2 different groups on Day 0. Group 1, will be given Myostaal liniment application along with physiotherapy for 90 days and Group 2 will be given physiotherapy only for 90 days. On day 0, Baseline WOMAC index score and VAS score, Lequesne severity index score, 5 times sit to stand test, 6 minutes’ walk test and single leg stance test will be done and baseline values will be recorded. All the participants will be given Tab Paracetamol 650mg (Tab. Paracip 650 mg) to be taken as and when required in case of severe pain.  All the patients will be asked to follow up in physiotherapy OPD on day 15, day 30, day 60 and day 90. At each visit, a complete physical examination will be done by the physician. The participants will be assessed for the WOMAC index score, VAS score, Lequesne severity index score, 6 minutes’ walk test, 5 times sit to stand test, single leg stance test and participant’s global assessment score and will be documented in CRF.

 
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