The Efficacy of TGF for Treating Osteoarthritis of the Knee
Status:
Not yet recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.