| CTRI Number |
CTRI/2020/11/029031 [Registered on: 10/11/2020] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of local application of Myostaal liniment in strengthening muscles in knee arthritis |
|
Scientific Title of Study
|
A prospective, randomized, comparative, parallel, 2-arm study to evaluate the efficacy and safety of a Myostaal liniment application as add on therapy for muscle strengthening in patients suffering from 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 Vaishali Shailesh Deshpande |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Kayachikitsa, Parul Institute of Ayurved and Research, AP Ishwarpura, Tal Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9096082950 |
| Fax |
|
| Email |
dr.vaishalid@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Vinayak Deshpande |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Kayachikitsa, Parul Institute of Ayurved, Parul University, AP Limda, Tal Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9763104451 |
| Fax |
|
| Email |
dr.shaileshd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Teja Devendra Naik |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Kayachikitsa, Parul Institute of Ayurved and Research, AP Ishwarpura, Tal Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8310167196 |
| Fax |
|
| Email |
teja.d.naik13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Solumiks Herbaceuticals Limited, 135, Nanubhai Desai Rd, Charni Road East, Khetwadi, Girgaon, Mumbai, Maharashtra 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
|
| Name |
Address |
| Superintendent |
Khemdas Ayurved Hospital, Parul University, AP Ishwarpura, Tal Waghodia, Vadodara, Gujarat 391760 |
| Superintendent |
Parul Ayurved Hospital, Parul University, AP Limda, Tal Waghodia, Vadodara, Gujarat 391760 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaishali S Deshpande |
Khemdas Ayurved Hospital |
OPD No 8, Khemdas Ayurved Hospital, Parul Institute of Ayurved and Research,Parul University, P.O. Limda, Tal. Waghodia,
Vadodara 391760
Vadodara
GUJARAT |
9096082950
dr.vaishalid@gmail.com |
| Dr Shailesh V Deshpande |
Parul Ayurved Hospital |
OPD 106, Parul Ayurved Hospital, Parul Institute of Ayurved, Parul University, AP Limda, Tal Waghodia, Vadodara 391760
Vadodara
GUJARAT |
9763104451
dr.shaileshd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research |
Approved |
| PIAR - Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Myostaal liniment application and Physiotherapy exercises for knee |
Local application of Myostaal liniment twice daily and standard physiotherapy exrecises for knee once daily
|
| Comparator Agent |
Physiotherapy exercises for knee |
Standard physiotherapy exercises for knee once daily |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed case of Idiopathic knee osteoarthritis for minimum 1month and maximum 5 years according to clinical guidelines of American college of Rheumatology.
2.Patient 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.
3. Patients who have Grades 1 and 2 in radiological findings.
4.Patients willing to give written informed consent.
5. |
|
| ExclusionCriteria |
| Details |
1. Patient with secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, post infectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement)
2. Patient on corticosteroid use:
(a) oral corticosteroid within the previous 14 days.
(b) intramuscular corticosteroid within 30 days.
(c) intra-articular corticosteroid into the study knee within 90 days.
(d) intra-articular corticosteroid into any other joint within 30 days.
(e) topical corticosteroid at the site of application within 14 days; Or patient requiring systemic corticosteroids during the course of study.
3. Patient who has undergone or who is planning to undergo knee replacement surgery in next 3 months will be excluded from the study.
4. Patient who has underwent knee replacement surgery for the affected knee and who have undergone a knee arthroscopy within past 2 years. Patient with intra-articular visco supplementation (e.g., SynviscR) in the affected knee joint in the preceding 6 months.
5. Patients with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease.
6. Patient with history of clinically-active renal, hepatic or peptic ulcer disease.
7. History of life threatening cardiovascular and /or neurological event in the past one year.
8. Patient with history of alcohol or drug abuse, bleeding disorder.
9. Patient having any severe active infectious disease requiring hospitalization.
10. Pregnancy or lactation.
11. Patient known to have allergy for any of ingredients of study medicine. |
|
|
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 on basis of dynamometer readings |
at baseline and at the end of 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in symptoms of osteoarthritis of knee (pain, stiffness and physical function) on basis of WOMAC score |
at baseline, 15 days, 30 days, 45 days, 60 days, 75 days, 90 days |
Improvement in
1. 6 Minutes’ walk test,
2. Single leg stance test,
3. 5 times sit to stand test,
4. VAS score,
5.Lequesne severity index score |
at baseline, 15 days, 30 days, 45 days, 60 days, 75 days, 90 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/11/2020 |
| Date of Study Completion (India) |
27/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteoarthritis
(OA) is the most prevalent form of arthritis in India and it is estimated to
affects over 15 million adults every year. Osteoarthritis continues to have
serious impact on the lives of elderly people but in the last few decades,
Indians in the age-group of 30 to 50 years are falling prey to this disease. By
2025, India is estimated to be the Chronic Disease Capital with 60 million
people suffering from arthritis.
Conventional
treatments for OA include pain medication (nonsteroidal anti-inflammatory drugs
and cyclooxygenase-2 inhibitors), exercises, hot and cold therapy,
corticosteroid injections and eventually, surgery to repair the joint. Despite
conventional treatment, OA is often progressive and frequently leads to chronic
pain and disability.3
In
osteoarthritis, NICE (National Institute of Health and Care Excellence)
Guidelines, United Kingdom, recommends exercise as a core treatment,
irrespective of age, comorbidity, pain severity or disability. Exercise should
include local muscle strengthening and general aerobic fitness.
In Ayurved
Massage is done with medicated oils like Mahanarayan Tel are widely used by
Ayurved practitioners to improve the tone of periarticular muscles. |