Evaluation of the efficacy and safety of NRL/2019/JC capsules in knee osteoarthritis: A randomized, double-blind, placebo controlled crossover clinical study.
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Symptom improvement like morning stiffness, tiredness, tenderness, and muscle spasms
Study Overview
Brief Summary
Osteoarthritis (OA) is a long-term chronicdisease characterized by the deterioration of cartilage in joints which resultsin bones rubbing together and creating stiffness, pain, and impaired movement.The disease most commonly affects the joints in the knees, hands, feet, andspine and is relatively common in shoulder and hip joints. While OA is relatedto ageing, it is also associated with a variety of both modifiable and nomodifiable risk factors, including: obesity, lack of exercise, geneticpredisposition, bone density, occupational injury, trauma, and gender. Theprevalence of OA is increasing due to population ageing and an increase inrelated factors such as obesity.
In this study clinical crossover study of NRL/2019/JC capsules with placebo is planned to validate polyherbal formulation in management of knee osteoarthritis.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Double Blind Double Dummy
Eligibility Criteria
- Ages
- 40.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
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
- •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/m
- •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.
Outcomes
Primary Outcomes
Symptom improvement like morning stiffness, tiredness, tenderness, and muscle spasms
Time Frame: Screening day, Baseline Day, Day 30, 60 and 90.
Pain, stiffness and difficulty in movement by WOMAC score between the groups.
Time Frame: Screening day, Baseline Day, Day 30, 60 and 90.
Physicians global Assessment of performance of patient on pain VAS scale
Time Frame: Screening day, Baseline Day, Day 30, 60 and 90.
Improvement in SF-36 Health Survey score
Time Frame: Screening day, Baseline Day, Day 30, 60 and 90.
Levels of inflammatory mediators CRP, IL-6, TNF-alpha
Time Frame: Screening day, Baseline Day, Day 30, 60 and 90.
Secondary Outcomes
- Proportion of subjects with reduced doses of NSAID(Drug compliance)