Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis.

Phase 2

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: TCM OA2; Drug: PLACEBO

• Registration Number: NCT04108832
• Lead Sponsor: Chung Shan Medical University

Brief Summary

Through an eight-week randomized, double-blind, placebo-controlled clinical trials formula to evaluate Chinese herbal compound OA2 improve osteoarthritis of efficacy and safety.

Detailed Description

This trial was a 8 weeks' randomized, double-blind, placebo-controlled study. The study was approved by the Institutional Review Board of Chung Shan Medical University hospital, and signed informed consent was obtained from each patient. Eighty-one patients of osteoarthritis of knees or hips were enrolled in this study. Inclusion criteria were: age 20 to 80 years; primary osteoarthritis in at least 1 knee, verified radiologically and scored (as normal, minimal, moderate or marked) for joint-space narrowing and marginal osteophytes in the medial, lateral and patellofemoral compartments; at least moderate pain during the 2 weeks before random assignment to treatment, as identified with the Western Ontario and McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale.

Primary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 4.

Secondary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 2; Visual analogue scale (VAS), Quality of life by SF-36, patient global assessment (PGA), at week 2 and 4; The PGA was scored from 0 to 4 (0 representing very good); Biomarkers: Hs-CRP, ESR.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2014-09-17
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-26
• Last Update Submitted: 2019-09-26
• Study First Posted: 2019-09-30
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Age ≥20 years old
• Written informed consent obtained
• Been diagnosed with knee or hip osteoarthritis
• The physician interpretation of X-ray identification and joint space narrowing or bone spurs confirmed
• In randomized trials before entering if used steroids or non-steroid medications osteoarthritis stable doses required at least one week
• The WOMAC osteoarthritis index of the degree of pain assessment in the past two weeks at least> 4ppm pain

Exclusion Criteria

• Pregnant or breast-feeding women.
• Chemotherapy or radiation therapy in cancer patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCM OA2	TCM OA2	TCM OA2 3G BID FOR 8 WEEKS
PLACEBO	PLACEBO	PLACEBO

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities (WOMAC)	week 0, week 4, week 8	The investigators use WOMAC to compared the difference between the week 8 and week 0

Secondary Outcome Measures

Name	Time	Method
Quality of life by SF-36	week0, week 2 and week 4	The investigators use SF-36 to compared the difference between the week 4 and week 0, week 2 and week 0
Erythrocyte sedimentation rate (ESR)	week0, week 8	The investigators use ESR to compared the difference between the week 8 and week 0
High sensitivity C-reactive protein (Hs-CRP)	week0, week 8	The investigators use Hs-CRP to compared the difference between the week 8 and week 0
Visual Analog Scale for pain (VAS)	week0, week 4 and 8	The investigators use VAS to compared the difference between the week 4 and week 0, week 8 and week 0
Physicians Global Assessment to measure quality of life (PGA)	week0, week 4 and week 8	The investigators use PGA to compared the difference between the week 4 and week 0, week 8 and week 0

Trial Locations

Locations (1)

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan