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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04108832
• Other study ID #: CS13048
• Status: Completed
• Phase: Phase 2
• Start date: January 2012
• Est. completion date: October 2013

Study information

• Verified date: September 2019
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• TCM OA2
Usage: 3g twice daily
• PLACEBO
Usage: 3g twice daily

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Erythrocyte sedimentation rate (ESR)	The investigators use ESR to compared the difference between the week 8 and week 0	week0, week 8