Clinical Study to evaluate the Efficacy and Safety of EASY CLIMB CAPSULES in Patients with Painful knee Osteoarthritisâ??

Not Applicable

Completed

• Conditions: Health Condition 1: M15-M19- Osteoarthritis

• Registration Number: CTRI/2014/11/005205
• Lead Sponsor: atsyn Catalysts

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-05-11
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

•Men and women with age of 40 â?? 65 with a diagnosis of arthritis.

•Obtaining written Inform consent along with audio, video visual.

•Patients with mild to moderate arthritis

•Participants who are able to visit the medical institutions throughout the study period

Exclusion Criteria

•Patients with Uncontrolled hypertension or diabetes.

•Patients with Hepatic or renal impairment

•Patients with Current or expected use of anticoagulant

•Candidates for imminent joint replacement

•Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months

•Participation within 30 days prior to screening in another investigational study

•Conditions in the opinion of the investigator make the patient unsuitable to participate in the study.

•Any contraindication to blood sampling.

•HIV Positive serology

•Pregnant (or) Lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢Patients Assessment of Osteoarthritis Pain by VAS [Osteoarthritis- Pain Visual analog scale (VAS)] <br/ ><br>â?¢Change from Baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index-pain subscale score <br/ ><br>â?¢WOMAC Osteoarthritis Composite Index & QOL <br/ ><br>â?¢Changes in the arthritis impact measurement scale (AIMS 2) <br/ ><br>â?¢Change from Baseline in the CGI (Clinical Global Impression) scale score <br/ ><br>â?¢Changes in Comprehensive Metabolic Panel (CMP), &Synovial Fluid analysis. <br/ ><br>Timepoint: â?¢Screening to EOT (Day 120)

Secondary Outcome Measures

Name	Time	Method
Safety assessed by Adverse EventsTimepoint: Screening to EOT (Day 120)