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

Chung Shan Medical University60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Osteoarthritis

Interventions

JING CEIH SHERN YUAN EXTRACT PILLDRUG

Oral use, 3#BID

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Western Ontario and McMaster Universities (WOMAC)

The investigators use WOMAC to compared the difference between the week 12 and week 0

Time frame: week 0, week 12

Secondary Outcomes

serum osteocalcin level

The investigators use serum osteocalcin level to compared the difference between week 12 and week 0

Time frame: week 0, week 12

serum C-terminal telopeptide (CTX) level

The investigators use serum CTX level to compared the difference between week 12 and week 0

Time frame: week 0, week 12

Western Ontario and McMaster Universities (WOMAC)

The investigators use WOMAC to compared the difference between the week 4 and week 0, week 8 and week 0

Time frame: week 0, week 4, week 8

Visual Analog Scale for pain (VAS)

The investigators use VAS to compared the difference between the week 4 and week 0, week 8 and week 0, week 12 and week 0

Time frame: week 0, week 4, week 8, week 12

Physicians Global Assessment to measure quality of life (PGA)

The investigators use PGA to compared the difference between the week 4 and week 0, week 8 and week 0, week 12 and week 0

Time frame: week 0, week 4, week 8, week 12

Quality of life by SF-36

The investigators use SF-36 to compared the difference between the week 4 and week 0, week 8 and week 0, week 12 and week 0

Time frame: week 0, week 4, week 8, week 12

Data from ClinicalTrials.gov

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