A clinical trial to assess the efficacy and safety of polyherbal supplement Osteolyn for control of pain in the patients with recent onset primary knee osteoarthritis

Not Applicable

Completed

• Conditions: Health Condition 1: M179- Osteoarthritis of knee, unspecified

• Registration Number: CTRI/2021/12/038379
• Lead Sponsor: Herbalyn Lifesciences Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-04-11
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

a. Male or female Subjects 18 to 60 years, both inclusive

b. Subject with diagnosis of primary OA Knees and not due to other local anatomical conditions such as bursitis, tendonitis, etc.,

c. Symptoms for at least 3 months prior to screening

d. The pain in the knees requires the use of pharmacological treatment

e. After discontinuing all pain medications for at least 2 days, had at least moderate pain on movement (POM) for knee, defined as a baseline score of � 50 mm on a 0-100 mm Visual Analog Scale (VAS) immediately prior to randomization, and a baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of at least 9 immediately prior to randomization.

f. Subject is willing to replace all current pain medications with rescue medication for use if needed during the duration of the study [subjects should be able to withhold all rescue medication (to be confirmed) use for at least 24 hours prior to all WOMAC pain score assessments at study visits].

g. Subject is well-motivated, capable, and willing to: a) willing to replace all current medications a) learn how to self-administer study treatment (Etodolac 200 mg Tablet, Osteolyn�® or placebo) and b) maintain a study diary

Exclusion Criteria

a. Pregnant or lactating or planning to become pregnant and women with reproductive potential unwilling to follow standard contraception methods.

b. History of any form of secondary arthritis and complication of osteoarthritis

c. History of rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.

d. History of established ischemic heart disease, peripheral arterial disease, cerebrovascular disease, congestive heart failure

e. History of asthma, hypertension, thrombotic events, stroke, impaired cognitive function, impaired renal function and impaired hepatic function.

f. History of gastrointestinal bleeding or peptic ulcer disease.

g. Known hypersensitivity to Aspirin and/or NSAID.

h. History of tobacco, drug and alcohol abuse

i. History of use of systemic and topical pain medications (to knees) in the four weeks prior to randomization.

j. Application of moisturizers, sunscreen, creams, lotions, powders or any topical (medicated or cosmetic) product the treatment knee area for duration of study.

k. History of major knee surgery or injury of knee or any form of inflammatory arthritis.

l. Subject with hypersensitivity to any of the study products.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline to 90 days Treatment period (Day 0 and Day 90) in: Mean improvement of pain (pain in VAS Scale as the main parameter of comparison) as per Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in PP and comparison between the study armsTimepoint: day 0 to day 90

Secondary Outcome Measures

Name	Time	Method
1 WOMAC subscales with patient assessment of primary OA. <br/ ><br>2 Questionnaire ââ?¬â?? VAS (Visual Analogue Scale) ââ?¬â?? QOL (Quality of Life) <br/ ><br>3 Treatment-emergent adverse events (TEAEs) with respect to Test IP/ Active comparator/Placebo products collected throughout the study. <br/ ><br>4 Gender and Age-related comparisons of symptoms of primary OA. <br/ ><br>Timepoint: day 0 to day 90