Clinical study on AQUA-TURM® in Knee arthritis patients

Phase 2

Completed

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

• Registration Number: CTRI/2021/08/035416
• Lead Sponsor: odaat Pharma

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: 0

Inclusion Criteria

1.History of knee pain due to osteoarthritis requiring use of NSAIDs, Acetaminophen, or another analgesic agent.

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

3.Knee joint(s) pain greater than or equal to 40 on Visual Analogue Scale (VAS).

Exclusion Criteria

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

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

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

4. 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

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

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

7. Subjects with uncontrolled diabetes mellitus and hypertension

8. Subjects with known tuberculosis, HIV, ischemic heart disease, cancer, kidney failure

9. Pregnant and lactating women

10. Subjects with significant abnormal laboratory parameters

11. Known hypersensitivity to any of the ingredients of AQUA-TURM

12. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrollment or could interfere with his/her participation in, and completion of the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1). Comparative change in knee Joint Pain on VAS between two groups <br/ ><br>2). Comparative change in WOMAC Index between two groups <br/ ><br>Timepoint: Day -3, Day 0, Day 30, Day 60, Day 90

Secondary Outcome Measures

Name	Time	Method
1). Comparative change in time to walk 50 feet while walking on even surface <br/ ><br>2). Comparative change in use of Paracetamol or NSAID as rescue medicine <br/ ><br>3). Comparative change in knee joint swelling <br/ ><br>4). Comparative Change in CRP level between two groups <br/ ><br>5). Comparative changes in the X Ray of Knee Joint <br/ ><br>6). Comparative change in global assessment for overall change by investigator and subject <br/ ><br>7). Comparative assessment of tolerability of study products by investigator and subject <br/ ><br>8). Adverse events assessment <br/ ><br>9). Comparative assessment of safety by assessing safety lab parameters <br/ ><br>Timepoint: Day -3, Day 0, Day 30, Day 60, Day 90