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

Chung Shan Medical University81 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Osteoarthritis

Interventions

TCM OA2DRUG

Usage: 3g twice daily

PLACEBODRUG

Usage: 3g twice daily

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

Outcomes

Primary Outcomes

Western Ontario and McMaster Universities (WOMAC)

The investigators use WOMAC to compared the difference between the week 8 and week 0

Time frame: week 0, week 4, week 8

Secondary Outcomes

Visual Analog Scale for pain (VAS)

The investigators use VAS to compared the difference between the week 4 and week 0, week 8 and week 0

Time frame: week0, week 4 and 8

Physicians Global Assessment to measure quality of life (PGA)

The investigators use PGA to compared the difference between the week 4 and week 0, week 8 and week 0

Time frame: week0, week 4 and week 8

Quality of life by SF-36

The investigators use SF-36 to compared the difference between the week 4 and week 0, week 2 and week 0

Time frame: week0, week 2 and week 4

High sensitivity C-reactive protein (Hs-CRP)

The investigators use Hs-CRP to compared the difference between the week 8 and week 0

Time frame: week0, week 8

Erythrocyte sedimentation rate (ESR)

The investigators use ESR to compared the difference between the week 8 and week 0

Time frame: week0, week 8

Data from ClinicalTrials.gov

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