Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2025-12-29 @ 10:21 AM
Study NCT ID:
NCT04108832
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2014-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis.
Sponsor:
Chung Shan Medical University
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: