Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips.

Chung Shan Medical University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: JING CEIH SHERN YUAN EXTRACT PILL

Study type: Interventional

Funder types: Other

Identifiers

NCT04110847

CS09165

Details and patient eligibility

About

To investigate the efficacy and safety of OA1 Extract capsules in the treatment of patients with knee or hip osteoarthritis (OA).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

TCM OA1

Active Comparator group

Description:

JING CEIH SHERN YUAN EXTRACT PILL "CHUANG SONG ZONG" 3 TABLET For 2 Times per day

Treatment:

Drug: JING CEIH SHERN YUAN EXTRACT PILL

Placebo

Placebo Comparator group

Description:

Placebo 3 TABLET For 2 Times per day

Treatment:

Drug: JING CEIH SHERN YUAN EXTRACT PILL