Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis.
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
TCM OA2
PLACEBO
Sponsored by
About this trial
This is an interventional basic science trial for Osteoarthritis focused on measuring Traditional Chinese Medicine, Herbs, Liu-wei-die-Huang-Wan
Eligibility 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
Sites / Locations
- Chung Shan Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TCM OA2
PLACEBO
Arm Description
TCM OA2 3G BID FOR 8 WEEKS
PLACEBO
Outcomes
Primary Outcome Measures
Western Ontario and McMaster Universities (WOMAC)
The investigators use WOMAC to compared the difference between the week 8 and week 0
Secondary Outcome Measures
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
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
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
High sensitivity C-reactive protein (Hs-CRP)
The investigators use Hs-CRP to compared the difference between the week 8 and week 0
Erythrocyte sedimentation rate (ESR)
The investigators use ESR to compared the difference between the week 8 and week 0
Full Information
NCT ID
NCT04108832
First Posted
September 17, 2014
Last Updated
September 26, 2019
Sponsor
Chung Shan Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04108832
Brief Title
Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis.
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 Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Traditional Chinese Medicine, Herbs, Liu-wei-die-Huang-Wan
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TCM OA2
Arm Type
Experimental
Arm Description
TCM OA2 3G BID FOR 8 WEEKS
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
PLACEBO
Intervention Type
Drug
Intervention Name(s)
TCM OA2
Other Intervention Name(s)
LIOW WEY DIH HUANG WAN EXTRACT PILL
Intervention Description
Usage: 3g twice daily
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Intervention Description
Usage: 3g twice daily
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities (WOMAC)
Description
The investigators use WOMAC to compared the difference between the week 8 and week 0
Time Frame
week 0, week 4, week 8
Secondary Outcome Measure Information:
Title
Visual Analog Scale for pain (VAS)
Description
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
Title
Physicians Global Assessment to measure quality of life (PGA)
Description
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
Title
Quality of life by SF-36
Description
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
Title
High sensitivity C-reactive protein (Hs-CRP)
Description
The investigators use Hs-CRP to compared the difference between the week 8 and week 0
Time Frame
week0, week 8
Title
Erythrocyte sedimentation rate (ESR)
Description
The investigators use ESR to compared the difference between the week 8 and week 0
Time Frame
week0, week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei C- C, M.D.
Organizational Affiliation
Chung Shan Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis.
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