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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
JING CEIH SHERN YUAN EXTRACT PILL
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoarthritis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    TCM OA1

    Placebo

    Arm Description

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

    Placebo 3 TABLET For 2 Times per day

    Outcomes

    Primary Outcome Measures

    Western Ontario and McMaster Universities (WOMAC)
    The investigators use WOMAC to compared the difference between the week 12 and week 0

    Secondary Outcome Measures

    serum osteocalcin level
    The investigators use serum osteocalcin level to compared the difference between week 12 and week 0
    serum C-terminal telopeptide (CTX) level
    The investigators use serum CTX level to compared the difference between week 12 and week 0
    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
    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
    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
    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
    High sensitivity C-reactive protein (Hs-CRP)
    The investigators use Hs-CRP to compared the difference between the week 12 and week 0
    Erythrocyte sedimentation rate (ESR)
    The investigators use ESR to compared the difference between the week 12 and week 0

    Full Information

    First Posted
    September 30, 2019
    Last Updated
    September 30, 2019
    Sponsor
    Chung Shan Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04110847
    Brief Title
    Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips.
    Official Title
    Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips. A Randomized Double-Blind, Placebo-Controlled Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 22, 2010 (Actual)
    Primary Completion Date
    December 5, 2011 (Actual)
    Study Completion Date
    January 10, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chung Shan Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TCM OA1
    Arm Type
    Active Comparator
    Arm Description
    JING CEIH SHERN YUAN EXTRACT PILL "CHUANG SONG ZONG" 3 TABLET For 2 Times per day
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo 3 TABLET For 2 Times per day
    Intervention Type
    Drug
    Intervention Name(s)
    JING CEIH SHERN YUAN EXTRACT PILL
    Intervention Description
    Oral use, 3#BID
    Primary Outcome Measure Information:
    Title
    Western Ontario and McMaster Universities (WOMAC)
    Description
    The investigators use WOMAC to compared the difference between the week 12 and week 0
    Time Frame
    week 0, week 12
    Secondary Outcome Measure Information:
    Title
    serum osteocalcin level
    Description
    The investigators use serum osteocalcin level to compared the difference between week 12 and week 0
    Time Frame
    week 0, week 12
    Title
    serum C-terminal telopeptide (CTX) level
    Description
    The investigators use serum CTX level to compared the difference between week 12 and week 0
    Time Frame
    week 0, week 12
    Title
    Western Ontario and McMaster Universities (WOMAC)
    Description
    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
    Title
    Visual Analog Scale for pain (VAS)
    Description
    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
    Title
    Physicians Global Assessment to measure quality of life (PGA)
    Description
    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
    Title
    Quality of life by SF-36
    Description
    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
    Title
    High sensitivity C-reactive protein (Hs-CRP)
    Description
    The investigators use Hs-CRP to compared the difference between the week 12 and week 0
    Time Frame
    week 0, week 12
    Title
    Erythrocyte sedimentation rate (ESR)
    Description
    The investigators use ESR to compared the difference between the week 12 and week 0
    Time Frame
    week 0, week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cheng Ching Wei, Ph. D.
    Organizational Affiliation
    Chung Shan Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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