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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04108832
Recruitment Status : Completed
First Posted : September 30, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Cheng-Chung Wei, 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: TCM OA2 Drug: PLACEBO Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
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.
Study Start Date : January 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: TCM OA2
TCM OA2 3G BID FOR 8 WEEKS
Drug: TCM OA2
Usage: 3g twice daily
Other Name: LIOW WEY DIH HUANG WAN EXTRACT PILL

Placebo Comparator: PLACEBO
PLACEBO
Drug: PLACEBO
Usage: 3g twice daily




Primary Outcome Measures :
  1. Western Ontario and McMaster Universities (WOMAC) [ Time Frame: week 0, week 4, week 8 ]
    The investigators use WOMAC to compared the difference between the week 8 and week 0


Secondary Outcome Measures :
  1. Visual Analog Scale for pain (VAS) [ Time Frame: 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

  2. Physicians Global Assessment to measure quality of life (PGA) [ Time Frame: 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

  3. Quality of life by SF-36 [ Time Frame: 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

  4. High sensitivity C-reactive protein (Hs-CRP) [ Time Frame: week0, week 8 ]
    The investigators use Hs-CRP to compared the difference between the week 8 and week 0

  5. Erythrocyte sedimentation rate (ESR) [ Time Frame: week0, week 8 ]
    The investigators use ESR to compared the difference between the week 8 and week 0



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108832


Locations
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Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan, 402
Sponsors and Collaborators
Chung Shan Medical University
Investigators
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Study Director: Wei C- C, M.D. Chung Shan Medical University
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Responsible Party: Cheng-Chung Wei, Professor, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT04108832    
Other Study ID Numbers: CS13048
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cheng-Chung Wei, Chung Shan Medical University:
Traditional Chinese Medicine
Herbs
Liu-wei-die-Huang-Wan
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases