Effect of Collashot C2 Plus inosteoarthritis patients
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2023/09/057515
- Lead Sponsor
- Innovcare LifeSciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology (ACR)
criteria and confirmed with X-rays and ACR functional class of III and with grade 3 or 4 as per
Kellgren and Lawrence classification system.
2. Have been on stable dose of prescription Nonsteroidal Anti- Inflammatory Drugs (NSAIDS), or
acetaminophen of at least 2000 mg per day for at least 20 days in the past month.
3. Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale
(VAS)
4. Patient should have not participated in any other clinical trial during the past 3 months.
5. Participants, who are willing to give written, signed and dated informed consent to participate in
the study.
1. Arthritis of the knee from other causes
2. Uncontrolled hypertension or diabetes
3. Have OA pain that requires treatment with potent opioids, systemic corticosteroids, intra-
articular injections, duloxetine, or venlafaxine
4. Moderate to severe renal impairment
5. Pregnant or lactating
6. Received any other investigational medicine within 7 days prior to screening which can
interfere with investigational product activity
7. Suffering from any illness which will interfere with present study as decided by clinical
investigator
8. History of hypersensitivity to any of the test products.
9. Any condition decided as unfit for study by clinical investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method