Real world evidence study to assess effectiveness & safety of HAPID® in the management of patients with Knee Osteoarthritis

Active, not recruiting

• Conditions: Osteoarthritis of knee, unspecified,

• Registration Number: CTRI/2021/07/034559
• Lead Sponsor: Wockhardt Ltd

Brief Summary

This is a prospective, observational, real world evidence study toassess effectiveness and safety of HAPID® (Un-denatured Type II Collagen and Aflapin) of Wockhardt Limited inthe management of patients with Knee Osteoarthritis.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-07
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Ambulatory adult patient, clinically or radiologically confirmed diagnosis of Knee Osteoarthritis newly prescribed with HAPID® (Un-denatured Type II Collagen and Aflapin), willing to provide written informed consent and comply to the study as per protocol.

Exclusion Criteria

1.History or evidence of hypersensitivity to any component of study medication 2.History of viscosupplementation within 9 months prior to date of screening 3.History of allergy to eggs or chicken 4.Pregnant or lactating women 5.Any other reason which in opinion of investigator preludes participation in study.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in Mean overall WOMAC score	Day 1, Day 5, Day 30, Day 60 and Day 90.
2. Change in Mean VAS score	Day 1, Day 5, Day 30, Day 60 and Day 90.
3. Change in Mean WOMAC subscales	Day 1, Day 5, Day 30, Day 60 and Day 90.

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events, during treatment with HAPID®	Day 1, Day 5, Day 30, Day 60 and Day 90.

Trial Locations

Locations (1)

Criticare Multispeciality Hospital and Research Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Criticare Multispeciality Hospital and Research Centre

🇮🇳Mumbai, MAHARASHTRA, India

Dr Atul Panghate

Principal investigator

02230103020

atulpanghate@gmail.com