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

Chung Shan Medical University

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: TCM OA2; Drug: PLACEBO

Study type: Interventional

Funder types: Other

Identifiers

NCT04108832

CS13048

Details and patient eligibility

About

Through an eight-week randomized, double-blind, placebo-controlled clinical trials formula to evaluate Chinese herbal compound OA2 improve osteoarthritis of efficacy and safety.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 2 patient groups, including a placebo group

TCM OA2

Experimental group

Description:

TCM OA2 3G BID FOR 8 WEEKS

Treatment:

Drug: TCM OA2

PLACEBO

Placebo Comparator group

Description:

PLACEBO

Treatment:

Drug: PLACEBO