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The Efficacy of TGF for Treating Osteoarthritis of the Knee

NCT03562429 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2018-06-21

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

TGF

TGF is a powder formulation of Hu-Qian Wan (HQW). HQW is composited of 10 herbs, Chinemys reevesii (Gray), Phellodendron chinense Schneid., Achyranthes bidentata Blume, Anemarrhena asphodeloides Bunge, Rehmannia glutinosa Libosch., Paeonia lactiflora Pall., Cynomorium songaricum Rupr., Angelica sinensis (Oliv.) Diels, Citrus reticulata Blanco and Zingiber officinale Rosc..

DRUG

TGFP

TGFP is 1/20 concentration of Hu-Qian Wan (HQW). HQW is composited of 10 herbs, Chinemys reevesii (Gray), Phellodendron chinense Schneid., Achyranthes bidentata Blume, Anemarrhena asphodeloides Bunge, Rehmannia glutinosa Libosch., Paeonia lactiflora Pall., Cynomorium songaricum Rupr., Angelica sinensis (Oliv.) Diels, Citrus reticulata Blanco and Zingiber officinale Rosc..

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Hen-Hong Chang · Dean of Chinese medicine, China Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2021-12-31
Completion
2021-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03562429 on ClinicalTrials.gov