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

Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips. A Randomized Double-Blind, Placebo-Controlled Clinical Trial.

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: JING CEIH SHERN YUAN EXTRACT PILL

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: TCM OA1; JING CEIH SHERN YUAN EXTRACT PILL "CHUANG SONG ZONG" 3 TABLET For 2 Times per day	Drug: JING CEIH SHERN YUAN EXTRACT PILL; Oral use, 3#BID
PLACEBO_COMPARATOR: Placebo; Placebo 3 TABLET For 2 Times per day	Drug: JING CEIH SHERN YUAN EXTRACT PILL; Oral use, 3#BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities (WOMAC)	The investigators use WOMAC to compared the difference between the week 12 and week 0	week 0, week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum osteocalcin level	The investigators use serum osteocalcin level to compared the difference between week 12 and week 0	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	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	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	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	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	week 0, week 4, week 8, week 12
High sensitivity C-reactive protein (Hs-CRP)	The investigators use Hs-CRP to compared the difference between the week 12 and week 0	week 0, week 12
Erythrocyte sedimentation rate (ESR)	The investigators use ESR to compared the difference between the week 12 and week 0	week 0, week 12

Collaborators and Investigators

• Sponsor: Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 22, 2010
• Primary Completion (ACTUAL): December 5, 2011
• Study Completion (ACTUAL): January 10, 2012

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CS09165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No