Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Collashot C2 Plus capsule.
Commiphora myrrha extract 4% (MyrLiq) 100 mg
Choline (as ch-OSA) 60 mg
Curcuma longa extract (CurQlife) 50 mg
Boswellia serrata extract (60%) 50 mg
Native (U
Sponsors
Innovcare LifeSciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. VAS pain score 2. WOMAC scoring 3. ESR, CRP and C-telopepetide 4. OMERACT-OARSI 5. Quality of lifeTimepoint: Day 0 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate safety and tolerability of study product by clinical AEs, including laboratory abnormalities (If any) Safety and tolerability evaluation criteria: Adverse events and serious adverse events during the study periodTimepoint: Day 0, Week 4, Week 8, Week 12 | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
KI3
Outcome results
None listed