Clinical trial of Re-Cart capsules in knee osteoarthritis

Not Applicable

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

• Registration Number: CTRI/2023/02/049625
• Lead Sponsor: Cachet Pharmaceuticals Pvt.Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Adults (age 18 to 60) both sex with BMI not more than 30.00 kg/m2;

2.Confirmed Diagnosis of knee osteoarthritis as per ACR (American College of Rheumatology)

3.Patient reported pain score between 5-15 (Both inclusive) on WOMAC-A scale at screening.

Exclusion Criteria

1.Conditions such as rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, pseudo gout or pain due to malignant disease as per clinical judgement or available evidences and laboratory findings with patients;

2.BMI >30 kg/m2;

3.Indication of surgery for OA knee;

4.Arthroscopy of either knee in the past year;

5.Use of systemic steroids or herbal medication for OA within 4 weeks of screening;

6.Use of Vit. D3 injections, Glucosamine sulphate, Chondroitin sulphate, Diacerin, Alendronate in the past 3 months;

7.Administration of intra-articular steroids in the past 3 month or hyaluronic acid in the last 9 months;

8.History of osteoporotic/ osteoarthritic fractures within the past 6 months;

9.Pregnant or lactating women or women with inadequate contraceptive measures;

10.Evidence or clinical suspicion of any major medical conditions (E.g. uncontrolled diabetes mellitus, uncontrolled hypertension, cardiovascular disease, thyroid, hepatic, renal dysfunction);

11.Presence of any clinically significant laboratory anomaly;

12.Moderate to severe peripheral neuropathy or other neurological disorders;

13.Alcohol abuse, medication or drug dependence.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.WOMAC A, B and C subscale scores for pain, stiffness and physical disability at baseline, day 30, 60 and end of the study. <br/ ><br>WOMAC-A is assessed by a Linkert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain, WOMAC- B for levels of stiffness and |WOMAC-C for levels of physical disability. <br/ ><br>2.Knee Range of Motion (ROM) results measured by goniometer at baseline and end of the study. <br/ ><br>3.Symptom grading on 4-point Linkert scale for joint swelling, tenderness, warmth at baseline to end of the study.Timepoint: Screening, Baseline, Day 30, Day 60 and Day 90

Secondary Outcome Measures

Name	Time	Method
1.Kellgren Lawrence radiological severity of Grade at baseline and end of the study. <br/ ><br>2.CRP and Il-6 levels at baseline and end of the study. <br/ ><br>3.Requirement of analgesic as a rescue medication at baseline, day 30, 60 and end of the study. <br/ ><br>4.Changes in gastrointestinal symptoms like heartburn, gastric discomfort, epigastric pain on 4 point Linkert scale. <br/ ><br>5.KOOS scoring for quality of life at baseline and end of the study. <br/ ><br>6.FACIT-F score at baseline and end of the study.Timepoint: Screening, Baseline, Day 30, Day 60 and Day 90