Real world evidence study to assess effectiveness & safety of HAPID�® in the management of patients with Knee Osteoarthritis
Not Applicable
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2021/07/034559
- Lead Sponsor
- Wockhardt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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 <br/ ><br>2. Change in Mean VAS score <br/ ><br>3. Change in Mean WOMAC subscalesTimepoint: 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�®Timepoint: Day 1, Day 5, Day 30, Day 60 and Day 90.