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
|
|
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
|
|
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. |