Clinical trial for safety and efficacy of grassroots leads in the management of Osteoarthritis of knee joints.

Phase 2

Completed

• Conditions: Health Condition 1: M171- Unilateral primary osteoarthritisof knee

• Registration Number: CTRI/2019/06/019881
• Lead Sponsor: ational innovation foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-04-25
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1.Patients with Primary Osteoarthritis â?? knee joints (single or both knees)

2.Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of OA and supported by radiological evidence (Kellgren Lawrence Grade II to IV) that is not older than 6 months prior to the date of screening

3.Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the WOMAC Index 5-point Likert Pain Subscale) assessed at screening

4.Moderate to moderately-severe OA pain in the index knee (even if chronic doses of nonsteroidal anti-inflammatory drug (NSAID), which have not changed in the 4 weeks prior to screening, have been/are being used)

5.No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an efficacy measure

6. No known clinically significant liver abnormality (e.g. cirrhosis, transplant, etc.).

Exclusion Criteria

1. Patient with history of hypersensitivity to any drugs.

2. Presence of tense effusions

3. Patients with Pottâ??s spine/infections/other systemic diseases

4. Patients with systemic conditions such as Gouty Arthritis, Rheumatoid Arthritis Psoriatic Arthritis, SLE.

5. Patients with Diabetes/Hypertension

6. Bed ridden patients

7. Chondromalacia

8. Any other disease or condition interfering with the free use and evaluation of the index

knee for the duration of the trial (e.g. cancer, congenital defects, spine osteoarthritis)

9. Major injury to the index knee within the 12 months prior to screening

10. Severe hip osteoarthritis ipsilateral to the index knee.

11. Any pain that could interfere with the assessment of index knee pain (e.g. pain in any

other part of the lower extremities, pain radiating to the knee)

12. Any pharmacological or non-pharmacological treatment targeting OA started or changed

during the 4 weeks prior to randomization or likely to be changed during the duration of the study

13. Patients with metallic implants.

14. History of bony or soft tissue injury to knee joint.

15. No human albumin treatment in the 3 months before randomization or throughout the

duration of the study.

16.Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified