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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04110847
• Other study ID #: CS09165
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 22, 2010
• Est. completion date: January 10, 2012

Study information

• Verified date: September 2019
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 10, 2012
• Est. primary completion date: December 5, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• JING CEIH SHERN YUAN EXTRACT PILL
Oral use, 3#BID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	serum osteocalcin level	The investigators use serum osteocalcin level to compared the difference between week 12 and week 0	week 0, week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Erythrocyte sedimentation rate (ESR)	The investigators use ESR to compared the difference between the week 12 and week 0	week 0, week 12