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

NCT ID: NCT04108832

Last Updated: 2019-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Keywords

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Traditional Chinese Medicine Herbs Liu-wei-die-Huang-Wan

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TCM OA2

TCM OA2 3G BID FOR 8 WEEKS

Group Type EXPERIMENTAL

TCM OA2

Intervention Type DRUG

Usage: 3g twice daily

PLACEBO

PLACEBO

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DRUG

Usage: 3g twice daily

Interventions

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TCM OA2

Usage: 3g twice daily

Intervention Type DRUG

PLACEBO

Usage: 3g twice daily

Intervention Type DRUG

Other Intervention Names

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LIOW WEY DIH HUANG WAN EXTRACT PILL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Cheng-Chung Wei

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei C- C, M.D.

Role: STUDY_DIRECTOR

Chung Shan Medical University

Locations

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Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CS13048

Identifier Type: -

Identifier Source: org_study_id