Effect of Collashot C2 Plus inosteoarthritis patients

Completed

Brief Summary: The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study.30 Participants will be randomized into single group. Dosing will be done daily orally for 12 weeks. Subjects will be asked to visit clinical facility/institution for their followup at the end of week 4, week 8 and week 12 and any other additional visits if needed.

Primary and Secondary Outcome

1)McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale

2) Pain VAS Scale

3) Hs-C Reactive Protein

4) ESR and C Telopeptide

5) Patientâ€™s Global Assessment of Osteoarthritis

6) Number of Participants with a response rate measured by the Outome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI)

7) Quality Life Questionnaires

8) XRay-Pre and Post

Recruitment & Eligibility

Inclusion Criteria

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.
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.
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.
Participants, who are willing to give written, signed and dated informed consent to participate in the study.

Exclusion Criteria

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.
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.
Any condition decided as unfit for study by clinical investigator.

Primary Outcome Measures

Secondary Outcome Measures

Name	Time	Method
To demonstrate safety and tolerability of study product by clinical AEs,	including laboratory abnormalities (If any)

Locations (1): Thirumalai Medical Centre
🇮🇳
Pondicherry, PONDICHERRY, India
Thirumalai Medical Centre
🇮🇳Pondicherry, PONDICHERRY, India
Dr M Sakthi Balan
Principal investigator
9443627722
saheerose@gmail.com