Safety of Joint Support Product in knee osteoarthritis
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2022/01/039176
- Lead Sponsor
- Mr Kamlesh Thummar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Male and/or female volunteers aged between 40 to 80 years both inclusive.
BMI ( �) greater than or equal to 24 Kg/m2 and less than or equal to (�) 38 Kg/m2
Willing to follow the diet advised by investigator
Willing to come for regular follow-up visits.
Patients diagnosed clinically with osteoarthritis of the knee based on the American College of Rheumatology (ACR) criteria.
Patients with congenital arthropathy, rheumatoid arthritis, active gout, other type of arthritis with/without inflammation e.g. septic, fibromyalgia or collagen vascular disease
Patients with known history of coagulopathies
Osteoarthritis of any other joint except knee
Patients with history of major trauma or surgery in the knee joint
Patients with uncontrolled diabetes and hypertension
Body mass index (BMI) >38 kg/m2.
Patients with any severe cardiac, renal and hepatic disease
Pregnant and lactating women
Patients who participated in any clinical trial within 30 days
before enrollment into the study
Any other condition which the Principal Investigator thinks
may jeopardize the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in levels of inflammatory mediators CRP, IL-6 <br/ ><br>Assessment of performance of patient on pain VAS scale. <br/ ><br>Local examination, clinical signs Assessment of WOMACTimepoint: Screening Day , Baseline Day, Day 30 , Day 60, Day 90
- Secondary Outcome Measures
Name Time Method Symptom improvement like morning sickness, tiredness, <br/ ><br>tenderness, and muscle spasms <br/ ><br>Assessment in Improvement in quality of life score <br/ ><br>Reduction in requirement of rescue analgesicsTimepoint: Screening Day , Baseline Day, Day 30 , Day 60, Day 90