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

NCT ID: NCT04110847

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-22
• Study Completion Date: 2012-01-10

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

TCM OA1

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

Group Type: ACTIVE_COMPARATOR

JING CEIH SHERN YUAN EXTRACT PILL

Intervention Type: DRUG

Oral use, 3#BID

Placebo

Placebo 3 TABLET For 2 Times per day

Group Type: PLACEBO_COMPARATOR

JING CEIH SHERN YUAN EXTRACT PILL

Intervention Type: DRUG

Oral use, 3#BID

Interventions

JING CEIH SHERN YUAN EXTRACT PILL

Oral use, 3#BID

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

Cheng-Chung Wei

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheng Ching Wei, Ph. D.

Role: STUDY_DIRECTOR

Chung Shan Medical University

Other Identifiers

CS09165

Identifier Type: -

Identifier Source: org_study_id