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Clinical Study of Efficacy and Safety of Chung A Won in Women's Patients With Osteoporosis

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Experimental
Sponsored by
Korea Health Industry Development Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

1)Female more than 50 years old in osteoporosis

Exclusion Criteria:

  1. Wash out peroid: using agents more than 3 months against osteoporosis
  2. Subject who takes drugs that may affect the clinical trials (Corticosteroids, anticonvulsants, tranquilizers, antidepressants, hypnotic, diuretic)
  3. Subject who has a chronic liver disease, thyroid disease and chronic renal disease
  4. Subject who is chronic alcoholics and undernourished
  5. Other conditions were not suitable in study : Severe physical defects mental defects
  6. Pregnant woman
  7. Subject who is not calibrated hypercalcemia/hypocalcemia
  8. Secondary osteoporosis : Subject who takes drugs(Glucocorticoid, Diabetes Medications)
  9. Subject who has 60% more fracture risk in FRAX(WHO fracture risk assessment tool)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental

    Placebo comparator

    Arm Description

    Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks

    Reference drug : Granules, Placebo 3g (Lactose hydrate, Corn starch, Caramel pigment) Three times a day, oral administration for 24weeks

    Outcomes

    Primary Outcome Measures

    The change of T-score of bone mineral density(QCT)

    Secondary Outcome Measures

    The change of T-score
    The change of osteoporosis-related indicators of blood tests
    The change of ODI(Oswestry Disability Index)
    The change of QVAS(Quardruple Visual Analog Scale)
    The change of kupperman index
    The change of shin-huh symptoms
    The change of quality of life using SF-36

    Full Information

    First Posted
    October 29, 2015
    Last Updated
    October 29, 2015
    Sponsor
    Korea Health Industry Development Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02592161
    Brief Title
    Clinical Study of Efficacy and Safety of Chung A Won in Women's Patients With Osteoporosis
    Official Title
    A Randomized, Single Center, Double Blind, Parallel, Placebo-controlled Clinical Study of Efficacy and Safety of Chung A Won in Women's Patients With Osteoporosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    November 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Korea Health Industry Development Institute

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A randomized, single center, double blind, parallel, placebo-controlled, clinical study of efficacy and safety of Chung A Won and placebo for 24 weeks three times a day on the improvement of osteoporosis and symptoms in Women's older than 50 patients with osteoporosis.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    166 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks
    Arm Title
    Placebo comparator
    Arm Type
    Placebo Comparator
    Arm Description
    Reference drug : Granules, Placebo 3g (Lactose hydrate, Corn starch, Caramel pigment) Three times a day, oral administration for 24weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Experimental
    Other Intervention Name(s)
    Chung A Won
    Intervention Description
    Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks Reference drug : Granules, Placebo 3g (Lactose hydrate, Corn starch, Caramel pigment) Three times a day, oral administration for 24weeks
    Primary Outcome Measure Information:
    Title
    The change of T-score of bone mineral density(QCT)
    Time Frame
    baseline, After 24 weeks(± 3 days) from the baseline of the trial
    Secondary Outcome Measure Information:
    Title
    The change of T-score
    Time Frame
    baseline, After 4 weeks, 12 weeks from the baseline of the trial
    Title
    The change of osteoporosis-related indicators of blood tests
    Time Frame
    baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial
    Title
    The change of ODI(Oswestry Disability Index)
    Time Frame
    baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial
    Title
    The change of QVAS(Quardruple Visual Analog Scale)
    Time Frame
    baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial
    Title
    The change of kupperman index
    Time Frame
    baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial
    Title
    The change of shin-huh symptoms
    Time Frame
    baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial
    Title
    The change of quality of life using SF-36
    Time Frame
    baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1)Female more than 50 years old in osteoporosis Exclusion Criteria: Wash out peroid: using agents more than 3 months against osteoporosis Subject who takes drugs that may affect the clinical trials (Corticosteroids, anticonvulsants, tranquilizers, antidepressants, hypnotic, diuretic) Subject who has a chronic liver disease, thyroid disease and chronic renal disease Subject who is chronic alcoholics and undernourished Other conditions were not suitable in study : Severe physical defects mental defects Pregnant woman Subject who is not calibrated hypercalcemia/hypocalcemia Secondary osteoporosis : Subject who takes drugs(Glucocorticoid, Diabetes Medications) Subject who has 60% more fracture risk in FRAX(WHO fracture risk assessment tool)

    12. IPD Sharing Statement

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    Clinical Study of Efficacy and Safety of Chung A Won in Women's Patients With Osteoporosis

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