Clinical trial of NRL/2019/JC capsules in knee osteoarthritis

Phase 1

• Conditions: Health Condition 1: M179- Osteoarthritis of knee, unspecified

• Registration Number: CTRI/2020/02/023199
• Lead Sponsor: etsurf Communications Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-07-10
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 108

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/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
Pain, stiffness and difficulty in movement by WOMAC score between the groups. <br/ ><br> <br/ ><br>Physicians global Assessment of performance of patient on pain VAS scale <br/ ><br> <br/ ><br>Improvement in SF-36 Health Survey score <br/ ><br> <br/ ><br>Levels of inflammatory mediators CRP, IL-6, TNF-alpha <br/ ><br> <br/ ><br>Symptom improvement like morning stiffness, tiredness, tenderness, and muscle spasms <br/ ><br>Timepoint: Screening day, Baseline Day, Day 30, 60 and 90.

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with reduced doses of NSAID <br/ ><br> <br/ ><br>Drug compliance <br/ ><br> <br/ ><br>Global assessment for overall improvement <br/ ><br> <br/ ><br>Tolerability of study drugs <br/ ><br> <br/ ><br>Adverse events/ Adverse drug reactions <br/ ><br> <br/ ><br>Vitals like pulse, body temperature, rate of respiration. <br/ ><br> <br/ ><br>Changes in biochemical parameters like, CBC, KFT, LFT and Urine routine etc. <br/ ><br>Timepoint: Screening day, Baseline Day, Day 30, 60 and 90.