Clinical trial NCT04110847: Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips.
Official title: Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips. A Randomized Double-Blind, Placebo-Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 60
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: To investigate the efficacy and safety of OA1 Extract capsules in the treatment of patients with knee or hip osteoarthritis (OA).

Detailed description: This trial was a 12 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. Sixty 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 or hip, verified; at least moderate pain during 2 weeks before random assignment to treatment, as identified by the Western Ontario and McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale for more than 4.

Primary outcome measures were WOMAC at week 12.

Secondary outcome measures were WOMAC at week 4 and 8; Visual analogue scale (VAS) , Quality of life by SF-36, patient global assessment (PGA), at week 4, 8 and 12; serum levels of osteocalcin, C-terminal telopeptide(CTX), Hs-CRP, and ESR.

Eligibility criteria: Inclusion Criteria:

* 1. Age ≥20 years old 2. Written informed consent obtained 3. Been diagnosed with knee or hip osteoarthritis 4. The physician interpretation of X-ray identification and joint space narrowing or bone spurs confirmed 5. In randomized trials before entering if used steroids or non-steroid medications osteoarthritis stable doses required at least one week 6. The WOMAC osteoarthritis index of the degree of pain assessment in the past two weeks at least\> 4ppm pain

Exclusion Criteria:

* 1. Pregnant or breast-feeding women. 2. Chemotherapy or radiation therapy in cancer patients

Primary outcomes:
measure: Western Ontario and McMaster Universities (WOMAC)
timeFrame: week 0, week 12
Secondary outcomes:
measure: serum osteocalcin level
timeFrame: week 0, week 12
measure: serum C-terminal telopeptide (CTX) level
timeFrame: week 0, week 12
measure: Western Ontario and McMaster Universities (WOMAC)
timeFrame: week 0, week 4, week 8
measure: Visual Analog Scale for pain (VAS)
timeFrame: week 0, week 4, week 8, week 12
measure: Physicians Global Assessment to measure quality of life (PGA)
timeFrame: week 0, week 4, week 8, week 12
measure: Quality of life by SF-36
timeFrame: week 0, week 4, week 8, week 12
measure: High sensitivity C-reactive protein (Hs-CRP)
timeFrame: week 0, week 12
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: week 0, week 12
Other outcomes:
Locations:
Study officials:
affiliation: Chung Shan Medical University
name: Cheng Ching Wei, Ph. D.
role: STUDY_DIRECTOR
References: