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

Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis. An Eight-Weeks Double Blind Randomized Placebo-Controlled Clinical Trial.

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: TCM OA2; Drug: PLACEBO

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 402
    • Chung Shan Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: PLACEBO	Drug: PLACEBO; Usage: 3g twice daily
Experimental: TCM OA2; TCM OA2 3G BID FOR 8 WEEKS	Drug: TCM OA2; Usage: 3g twice daily; Other Names: LIOW WEY DIH HUANG WAN EXTRACT PILL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities (WOMAC)	The investigators use WOMAC to compared the difference between the week 8 and week 0	week 0, week 4, week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	week0, week 8
Erythrocyte sedimentation rate (ESR)	The investigators use ESR to compared the difference between the week 8 and week 0	week0, week 8

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Investigators: Study Director: Wei C- C, M.D., Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; Herbs; Liu-wei-die-Huang-Wan
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CS13048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO