Clinical trial on AHPL/AYTOP/0314 liniment in arthritis patients
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2021/11/038235
- Lead Sponsor
- Ari Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 67
1) OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria (clinical and radiological) for the osteoarthritis of the knee(s)
2) Subjects with knee joint pain greater than 40 mm (VAS) on weight bearing activities
3) Subjects willing to participate in clinical trial and who have read understood and signed informed consent form
4) Subjects willing to make all required study visits.
1) Subjects diagnosed with or suffering from rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or any other major joint disorder.
2) Subjects with the history of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit.
3) Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study. 4) Subjects with signs of clinically important active inflammation of the study knee joint including redness, warmth and/or a large, bulging effusion with the loss of normal contour at the screening and or baseline visits.
5) Subject who used systemic corticosteroids within 2 months of screening, or intra-articular visco-supplementation within the past 3 months.
6) Subject with the use of any other investigational drug within 1 month prior to randomization.
7) Subjects having history of uncontrolled diabetes mellitus, uncontrolled hypertension, tuberculosis, cancer, HIV or ischemic heart diseases.
8) Subjects with known active and serious medical or surgical diseases
9) Pregnant or lactating women, or women of childbearing age not using a reliable method of contraception, or women of not child-bearing potential if not permanently sterilized or if not in post-menopausal status from at least two years.
10) Subjects with known hypersensitivity to ingredients used in study drugs.
11) Subjects with significant abnormal laboratory parameters
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparative assessment of knee joint pain on VAS within and between two groupsTimepoint: Day 0, Day 7, Day 14, Day 21 and Day 28
- Secondary Outcome Measures
Name Time Method 1) Comparative change in time required for onset of counter irritant action and pain reliever action after first application of investigational products <br/ ><br>2) Comparative change in duration of action with respect to counter irritant effect and pain reliever effect <br/ ><br>3) Comparative change in overall cooling effect and warmness effect of investigational products <br/ ><br>4) Comparative change in joint swelling <br/ ><br>5) Comparative change in time required to walk 50 feet distance on even surface <br/ ><br>6) Comparative change in WOMAC index <br/ ><br>7) Comparative change in use of rescue medications <br/ ><br>8) Comparative change in global assessment for overall change by physician and by patient. <br/ ><br>9) Assessment of Adverse Events <br/ ><br>10) Assessment of drug compliance. <br/ ><br>Timepoint: Day 0, Day 7, Day 14, Day 21 and Day 28