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CTRI Number  CTRI/2019/07/020058 [Registered on: 05/07/2019] Trial Registered Prospectively
Last Modified On: 26/06/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to evaluate the efficacy and safety of oral Myostaal forte a polyherbal formulation in preventing acute flares in patients suffering from osteoarthritis of knee 
Scientific Title of Study   A prospective, active-controlled, randomized, observer blind, comparative, parallel, 2-arm study to evaluate the efficacy and safety of oral Myostaal forte a polyherbal formulation in preventing acute flares 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 Raakhi Tripathi 
Designation  Associate Professor 
Affiliation  Seth GS Medical College & KEM Hospital  
Address  Dept. of Pharmacology and Therapeutics, Seth G.S. Medical College and KEM Hospital. Parel. Mumbai
Seth G.S. Medical College and KEM Hospital. Parel. Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  lookon@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Raakhi Tripathi 
Designation  Associate Professor 
Affiliation  Seth GS Medical College & KEM Hospital  
Address  Dept. of Pharmacology and Therapeutics, Seth G.S. Medical College and KEM Hospital. Parel. Mumbai
Seth G.S. Medical College and KEM Hospital. Parel. Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  lookon@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Raakhi Tripathi 
Designation  Associate Professor 
Affiliation  Seth GS Medical College & KEM Hospital  
Address  Dept. of Pharmacology and Therapeutics, Seth G.S. Medical College and KEM Hospital. Parel. Mumbai
Seth G.S. Medical College and KEM Hospital. Parel. Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  lookon@rediffmail.com  
 
Source of Monetary or Material Support  
Solumiks Herbaceuticals Ltd 135, Nanubhai Desai Road, Khetwadi, Near Wilson High School, Girgaon, Mumbai- 400 004. 
 
Primary Sponsor  
Name  Solumiks Herbaceuticals Ltd 
Address  135, Nanubhai Desai Road, Khetwadi, Near Wilson High School, 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 Mohan Desai  KEM Hospital   Orthopedics OPD no 404. Opp. Tata Hospital, Orthopaedic Centre Ground floor. KEM Hospital, Mumbai.400012
Mumbai
MAHARASHTRA 
9892275697

mohandesai@kem.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (II) Seth GS Medical College KEM Hospital,Mumbai, Maharashtra.  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tablet Glucosamine sulphate  One tablet of 500 mg three times daily for 6 months 
Intervention  Tablet Myostaal forte  One tablet three times daily for 6 months 
 
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 6 months 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
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 willing to give written informed consent.
4. Patients willing to follow up. 
 
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, 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. Patient who has undergone or who is planning to undergo 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. Also, Patient with intra-articular visco supplementation (e.g., Synvisc®) in the affected knee joint in the preceding 6 months
5. Patient with on-going use of medication including oral muscle relaxants, or low-dose antidepressant for any chronic pain management
6. Patients with on-going use of glucosamine or chondroitin sulphate or used continuously for 30 days prior to the study entry
7. Patients with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease.
8. Patient with abnormal Hb/CBC values, 10% beyond the normal range will lead to exclusion of the patient from the study.
9. Patient with laboratory parameters of Liver function test more than 1.5 times the upper limit of normal or detected any time during the study period will lead to exclusion of the patient from the study.
10. Patient with Serum Creatinine more than 1.5 mg/dl, detected any time during the study period will lead to exclusion of the patient from the study
11. Patient with history of clinically-active renal, hepatic or peptic ulcer disease
12. History of life threatening cardiovascular and /or neurological event in the past one year.
13. Patient with history of alcohol or drug abuse, bleeding disorder
14. Patient having any severe active infectious disease requiring hospitalization.
15. Pregnancy or lactation.
16. Patient who has taken study drug or any herbal medication in the past 4 weeks.
17. Patient with history of severe allergy or anaphylactic reaction.
18. Patient participating in another investigational drug trial in the previous 30 days.
19. Patients who cannot give valid consent such as mentally retarded, unconscious patients and psychiatric illness
20. Known history of positive screening result for hepatitis B and/or Hepatitis C virus.
21. History of HIV or any immune deficient conditions 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the significant reduction in the consumption of Tab Paracetamol per patient as an analgesic over a period of 6 months in both the groups  To compare the significant reduction in the consumption of Tab Paracetamol per patient as an analgesic over a period of 6 months in both the groups 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the number of patients showing a change in the WOMAC pain subscales score by at least 2 grades from To compare the number of patients showing a change in the WOMAC pain subscales score by at least 2 grades from baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups  Baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups 
To compare the number of patients showing a change in the WOMAC stiffness subscales score of 1 from baseline to day day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups  Baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups 
To compare the number of patients showing a change in the WOMAC physical function subscales score of 1 from baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups  Baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups 
To compare the number of patients achieving VAS score 3 from baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups  Baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups 
To compare the mean change in the Lequesne Impairment score from baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation visit in comparison to glucosamine group.  Baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation 
To compare the number of patients showing improvement (score 1) or complete resolution (score 0) in the Physician’s Global assessment score from baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups  Baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups 
To compare the mean change in Quality of life questionnaire score from baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups  Baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups 
To compare the mean change radiographic grading score of knee OA from baseline to day 180 or at the final visit at the time of subject discontinuation in both the groups  baseline to day 180 or at the final visit at the time of subject discontinuation in both the groups 
To compare the number of patients tolerating the drug and showing score 0 in the Patient’s Global safety assessment score from baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups.  baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups. 
To compare the number of patients showing adverse event from baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups  baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups. 
To compare the number of patients showing abnormal vital parameters from baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the group  baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the group 
To compare the number of patients showing abnormal systemic examination findings from baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups  baseline to day 45, day 90, day 135 and day 180 or at the final visit at the time of subject discontinuation in both the groups 
To compare the number of patients showing abnormal laboratory parameters from baseline to day 90 and day 180 at the final visit at the time of subject discontinuation in both the groups  baseline to day 90 and day 180 at the final visit at the time of subject discontinuation in both the groups 
 
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 2/ Phase 3 
Date of First Enrollment (India)   08/07/2019 
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="1" 
Recruitment Status of Trial (Global)   Not Applicable 
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)?  

Brief Summary  

Title: A prospective, active-controlled, randomized, observer blind, comparative, parallel, 2-arm study to evaluate the efficacy and safety of oral Myostaal forte, a polyherbal formulation as chondroprotective in patients suffering from osteoarthritis of knee

Study duration: 18 months

Primary Objective: To evaluate the efficacy of Myostaal forte in terms of significant reduction in use of analgesic medication (paracetamol) over a period of 6 months in comparison to glucosamine sulphate group.

Secondary Objective:
1. To evaluate the efficacy of Myostaal forte in patients suffering from knee joint osteoarthritis using the WOMAC pain subscale score, change by at least 2 grades from baseline to day 60, day 120 and day 180 or at the final visit at the time of subject discontinuation in comparison to glucosamine sulphate group
2. To evaluate efficacy of Myostaal forte in patients suffering from knee osteoarthritis using WOMAC stiffness sub-scale score, in terms of number of patients achieving score of <1 from baseline to day 60, day 120 and day 180 or at the final visit at the time of subject discontinuation visit in comparison to glucosamine sulphate group
3. To evaluate efficacy of Myostaal forte in patients suffering from knee osteoarthritis using WOMAC physical function sub-scale score, in terms of number of patients achieving score of <1 from baseline to day 60, day 120 and day 180 or at the final visit at the time of subject discontinuation visit in comparison to glucosamine sulphate group
4. To evaluate the efficacy of Myostaal forte in patients suffering from knee osteoarthritis by assessing the pain on a 100 mm Visual Analogue scale, in terms of number of patients achieving VAS score < 3 from baseline to day 60, day 120 and day 180 or at the final visit at the time of subject discontinuation visit in comparison to glucosamine sulphate group
5. To evaluate the efficacy of Myostaal forte in patients suffering from knee osteoarthritis by assessing the Lequesne severity index score from baseline to day 60, day 120 and day 180 or at the final visit at the time of subject discontinuation visit in comparison to glucosamine sulphate group.
6. To evaluate the overall improvement in patient by Patient’s Global assessment score.
7. To evaluate the overall improvement in patient by Physician’s Global assessment score.
8. To evaluate the quality of life of patients on SF-36 health questionnaire.
9. To assess the safety of drug on clinical and laboratory parameters (CBC, LFT and RFT).
10. To compare the radiographic grading of knee OA in patients at 6 months in comparison to baseline and with glucosamine sulphate group.

Inclusion criteria:
1. Patient of either sex in the age group of 40-70 years.
2. Diagnosed case of Idiopathic knee osteoarthritis for minimum 6 months 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. 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.
5. Patients willing to give written informed consent.
6. Patients willing to follow up.

Exclusion criteria:
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, 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. Patient 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., Synvisc®) in the affected knee joint in the preceding 6 months
4. Patient with on-going use of medication including oral muscle relaxants, or low-dose antidepressant for any chronic pain management
5. Patients with on-going use of glucosamine or chondroitin sulphate or used continuously for 30 days prior to the study entry
6. Patients with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease.
7. Patient with abnormal Hb/CBC values, 10% beyond the normal range will lead to exclusion of the patient from the study.
8. Patient with laboratory parameters of Liver function test more than 1.5 times the upper limit of normal or detected any time during the study period will lead to exclusion of the patient from the study.
9. Patient with Serum Creatinine more than 1.5 mg/dl, detected any time during the study period will lead to exclusion of the patient from the study
10. Patient with history of clinically-active renal, hepatic or peptic ulcer disease
11. History of life threatening cardiovascular and /or neurological event in the past one year.
12. Patient with history of alcohol or drug abuse, bleeding disorder
13. Patient having any severe active infectious disease requiring hospitalization.
14. Pregnancy or lactation.
15. Patient who has taken study drug or any herbal medication in the past 4 weeks.
16. Patient with history of severe allergy or anaphylactic reaction.
17. Patient participating in another investigational drug trial in the previous 30 days.
18. Patients who cannot give valid consent such as mentally retarded, unconscious patients and psychiatric illness
19. Known history of positive screening result for hepatitis B and/or Hepatitis C virus.
20. History of HIV or any immune deficient conditions

Efficacy parameters:
1. WOMAC INDEX
2. Visual Analogue Scale
3. Lequesne severity index score
4. Physician’s Global assessment score: 5. Quality of life – SF – 36 questionnaire
6. Radiographic grading of Knee OA – on X ray

Safety Parameters:
1. Patient’s Global assessment score:
2. Adverse events recording
3. Vital Parameters: Temperature, BP, HR, Respiratory rate
4. Systemic examination: CNS, CVS, RS, P/A
5. Blood Investigations: CBC, LFT, RFT
 
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