A clinical trial to study the effect of AHPL/AYTAB/0313 in patients suffering from arthritis of knee(s)

Phase 2

Completed

• Conditions: Health Condition 1: null- Osteoarthritis of Knee(s)

• Registration Number: CTRI/2015/09/006177
• Lead Sponsor: Ari Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

1.Subject willing to participate, who have read, understood and signed informed consent form

2.Subject with history of knee pain due to osteoarthritis requiring use of NSAIDs acetaminophen, or another analgesic agent on a regular basis (greater than or equal to 3 days per week) for at least 6 months before the screening visit.

3.OA confirmed by radiographs and diagnosed according to ACR diagnostic criteria (clinical and radiological) for the OA of the knee.

4.Subjects are willing to make all required study visits

5.Subjects are willing to follow study instructions given by the investigator

Exclusion Criteria

1.Subjects refused to give their informed consent

2.Subjects with rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease

3.Subjects with history of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit

4.Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study

5.Subjects with signs of clinically important active inflammation of the study knee joint including redness, warmth and or a large, bulging effusion with the loss of normal contour at the screening and or baseline visits

6.Subjects using systemic corticosteroids within 2 months of screening, or intraarticular visco-supplementation within the past 3 months

7.Subjects with any other investigational drug within 1 month prior to randomization;

8.Subjects having diabetes mellitus, tuberculosis, HIV, ischemic heart disease

9.Subjects with known major medical or surgical disease

10.Pregnant and lactating women

11.Subjects with known hypersensitivity to ingredients used in study drug.

12.Subjects with significant abnormal laboratory parameters

13.ECG demonstrating any signs of uncontrolled arrhythmia and or acute ischemia

Study & Design

• Study Type: Interventional
• Study Design: Not specified