Clinical trial NCT04108832: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Traditional Chinese Medicine
Herbs
Liu-wei-die-Huang-Wan
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 81
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Western Ontario and McMaster Universities (WOMAC)
timeFrame: week 0, week 4, week 8
Secondary outcomes:
measure: Visual Analog Scale for pain (VAS)
timeFrame: week0, week 4 and 8
measure: Physicians Global Assessment to measure quality of life (PGA)
timeFrame: week0, week 4 and week 8
measure: Quality of life by SF-36
timeFrame: week0, week 2 and week 4
measure: High sensitivity C-reactive protein (Hs-CRP)
timeFrame: week0, week 8
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: week0, week 8
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: Wei C- C, M.D.
role: STUDY_DIRECTOR
References: