A comparison of clinical outcome among undenatured collagen type II, Glucosamine sulphate and Diacerein on osteoarthritic knee treatment :A randomized controlled trial

Phase 2

• Conditions: This research is designed to fulfill the understanding of the clinical outcome of osteoarthritic knee treatment by Undenatured collagen type II, Glucosamine sulphate and Diacerein.; osteoarthritic knee, undenatured collagen type II, Glucosamine sulphate ,Diacerein, WOMAC scores

• Registration Number: TCTR20210901003
• Lead Sponsor: Department Orthopaedic Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study Completion: 2023-10-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

Primary knee OA based on the clinical criteria of the American College of Rheumatology
-Had radiographic evidence of OA with a Kellgren and Lawrance grade of 2-3
-Had not received UC-II or pCGS or diacerein within previous 6 months
-Had pain score (NPRS) at knee more than 4

Exclusion Criteria

-Had undergone knee replacement surgery
-Previous intra-articular treatment of the knee joint with any product(corticosteroids in the previous 2 months or hyaluronic acid in the previous 6months)
-Gastrointestinal disease (gastroesophageal reflux disorder, inflammatory bowel syndrome, peptic ulcer, and duodenal ulcer)
-Chronic kidney disease (GFR < 30)
-Liver disease (Cirrhosis child B-C,Hepatic failure,HCC)
-Uncontrolled diabetes mellitus (HbA1C < 7.0)
-Allergy to Undenatured collagen type II, Glucosamine sulphate, Diacerein, Acetaminophen, Naproxen
-Immobilization
-Usage of warfarin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WOMAC scores 0, 12, 24, 36 wks 220 points

Secondary Outcome Measures

Name	Time	Method
umeric pain rating scale 0, 12, 24, 36 wks counts the point,rescue medication 4, 12, 24, 36 wks times, dose of usage,joint space width 36 wks measure in millimeters,complication 4, 12, 24, 36 wks record forms, and history taking,6 min walk test and Time to get up and go test 24, 36 wks meters and seconds