Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: NRL/2019/JC: NRL/2019/JC capsule
1 BD after meals for 90 days
Control Intervention1: Placebo: Placebo capsules
1 BD after meals for 90 days
Sponsors
Netsurf Communications Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male and/or female volunteers aged between 40 to 60 years both inclusive. BMI greater than or equal to 24 Kg/m2 and less than or equal to 38 Kg/m2 Willing to come for regular follow-up visits. Patients diagnosed 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 |
|---|---|
| Pain, stiffness and difficulty in movement by WOMAC score between the groups. Physicians global Assessment of performance of patient on pain VAS scale Improvement in SF-36 Health Survey score Levels of inflammatory mediators CRP, IL-6, TNF-alpha Symptom improvement like morning stiffness, tiredness, tenderness, and muscle spasms Timepoint: Screening day, Baseline Day, Day 30, 60 and 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with reduced doses of NSAID Drug compliance Global assessment for overall improvement Tolerability of study drugs Adverse events/ Adverse drug reactions Vitals like pulse, body temperature, rate of respiration. Changes in biochemical parameters like, CBC, KFT, LFT and Urine routine etc. Timepoint: Screening day, Baseline Day, Day 30, 60 and 90. | — |
Countries
India
Contacts
Public ContactDr Omkar Kulkarni
Netsurf Research Labs Pvt Ltd
Outcome results
None listed