The Efficacy of TGF for Treating Osteoarthritis of the Knee

• Status: Not yet recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the efficacy of herbal formula TGF treating knee joint osteoarthritis(KOA) and its biochemical mechanism. The study design is a parallel randomized, placebo-controlled, double-blind clinical trial includes 180 patients with KOA. The patients are random allocated into study group(taking TGF) and control group(taking 1/20 TGF). After the 12 weeks treatment course, another 4 weeks is to follow-up the condition without medication. Assessments will be performed before and after treatment and the end of follow-up period.

The inclusion criteria are (1) age between 50~75 years old, (2) diagnosis of osteoarthritis:

The Clinical/Radiographic classification criteria of American College of Rheumatology, American College of Rheumatology, (3) chronic knee pain over 3 months. The exclusion criteria are (1) the past history with systemic joint disease, such as autoimmune disease, (2) the patient with history of knee surgery or waiting for the total knee replacement, (3) any disease that affect the function of lower extremities, such as trauma, tumor or compensation of abnormal posture, (4) the condition that cannot participate this study, (5) the subjects non-compliance with the protocol.

The Assessments including primarily the WOMAC (VAS version, 3.1), VAS and the used dosage of Celebrex before and after treatment. The secondary assessments are (1) X ray, (2) Constitution in Chinese Medicine Questionnaire, (3) Short From-36, (4) erythrocyte sedimentation rate and C reactive protein, (5) Biomarkers: C-telopeptide of type II collagen, cartilage oligomeric matrix protein, Osteocalcin, Leptin, Interleukin-1, Interleukin-6, matrix metalloproteinase-3, matrix metalloproteinase-13, ADAMTS-4, transglutaminase-2, and (6) metabolomics.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University Hospital

Criteria

Inclusion Criteria:

1. age between 50~75 years old

2. diagnosis of osteoarthritis: The Clinical/Radiographic classification criteria of American College of Rheumatology, ACR

3. chronic knee pain over 3 months.

Exclusion Criteria:

1. the past history with systemic joint disease, such as autoimmune disease

2. the patient with history of knee surgery or waiting for the total knee replacement

3. any disease that affect the function of lower extremities, such as trauma, tumor or compensation of abnormal posture

4. the condition that cannot participate this study

5. the subjects non-compliance with the protocol