Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110847
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Cheng-Chung Wei, Chung Shan Medical University

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: JING CEIH SHERN YUAN EXTRACT PILL Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips. A Randomized Double-Blind, Placebo-Controlled Clinical Trial.
Actual Study Start Date : March 22, 2010
Actual Primary Completion Date : December 5, 2011
Actual Study Completion Date : January 10, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  1. Western Ontario and McMaster Universities (WOMAC) [ Time Frame: week 0, week 12 ]
    The investigators use WOMAC to compared the difference between the week 12 and week 0


Secondary Outcome Measures :
  1. serum osteocalcin level [ Time Frame: week 0, week 12 ]
    The investigators use serum osteocalcin level to compared the difference between week 12 and week 0

  2. serum C-terminal telopeptide (CTX) level [ Time Frame: week 0, week 12 ]
    The investigators use serum CTX level to compared the difference between week 12 and week 0

  3. Western Ontario and McMaster Universities (WOMAC) [ Time Frame: week 0, week 4, week 8 ]
    The investigators use WOMAC to compared the difference between the week 4 and week 0, week 8 and week 0

  4. Visual Analog Scale for pain (VAS) [ Time Frame: week 0, week 4, week 8, week 12 ]
    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

  5. Physicians Global Assessment to measure quality of life (PGA) [ Time Frame: week 0, week 4, week 8, week 12 ]
    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

  6. Quality of life by SF-36 [ Time Frame: week 0, week 4, week 8, week 12 ]
    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

  7. High sensitivity C-reactive protein (Hs-CRP) [ Time Frame: week 0, week 12 ]
    The investigators use Hs-CRP to compared the difference between the week 12 and week 0

  8. Erythrocyte sedimentation rate (ESR) [ Time Frame: week 0, week 12 ]
    The investigators use ESR to compared the difference between the week 12 and week 0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110847


Sponsors and Collaborators
Chung Shan Medical University
Investigators
Layout table for investigator information
Study Director: Cheng Ching Wei, Ph. D. Chung Shan Medical University
Layout table for additonal information
Responsible Party: Cheng-Chung Wei, Professor, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT04110847    
Other Study ID Numbers: CS09165
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases