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

Phase 2/3

Not yet recruiting

• Conditions: Osteoarthritis of knee, unspecified,

• Registration Number: CTRI/2019/07/020058
• Lead Sponsor: Solumiks Herbaceuticals Ltd

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-06-26
• Study Start: 2019-08-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.
• 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.

Exclusion Criteria

• 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.
• 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.
• 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.
• 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.
• Patient with history of alcohol or drug abuse, bleeding disorder 14.
• Patient having any severe active infectious disease requiring hospitalization.
• Pregnancy or lactation.
• Patient with history of severe allergy or anaphylactic reaction.
• Patient participating in another investigational drug trial in the previous 30 days.
• 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.
• History of HIV or any immune deficient conditions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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 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
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

Trial Locations

Locations (1)

KEM Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

KEM Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Mohan Desai

Principal investigator

9892275697

mohandesai@kem.edu