Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Joint Support Product (GP/PROD/2021/002): 2 tablets twice a day after meals for 3 months.
Control Intervention1: Placebo tablets: 2 tablets twice a day after meals for 3 months.
Sponsors
Mr Kamlesh Thummar
Mr Pritesh Shah
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in levels of inflammatory mediators CRP, IL-6 Assessment of performance of patient on pain VAS scale. Local examination, clinical signs Assessment of WOMACTimepoint: Screening Day , Baseline Day, Day 30 , Day 60, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom improvement like morning sickness, tiredness, tenderness, and muscle spasms Assessment in Improvement in quality of life score Reduction in requirement of rescue analgesicsTimepoint: Screening Day , Baseline Day, Day 30 , Day 60, Day 90 | — |
Countries
India
Contacts
Public ContactMr Chetan savaliya
Gplife Healthcare Pvt Ltd
Outcome results
None listed