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A Trial for Evaluation of Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea (Healingstone)

Primary Purpose

Primary Dysmenorrhea

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Healingstone navel belt
Sponsored by
Healingstone Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Healingstone

Eligibility Criteria

15 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age : female adults aged 15~45 years
  • Subjects should diagnosed as primary dysmenorrhea, should have a primary dysmenorrhea at least a 1-day during menstrual.
  • Subjects should have 21~42 days menstrual cycle.
  • menstrual pain : primary dysmenorrhea at least a 1-day during menstruation is over 5 VAS(Visual Analogue Scale) without drug.
  • Subjects must have no Serious internal medicine.
  • Subjects must provide signed informed consent prior to participation in any study-related procedures

Exclusion Criteria:

  • Subject that oral contraceptive taken within 3 months
  • Pregnancy or lactation.
  • Subject have contraceptive that secrete hormone.
  • Secondary dysmenorrhea
  • pelvis inflammatory disease patient
  • Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    No Intervention

    Arm Label

    a

    b

    Arm Description

    healingstone

    stone powder

    Outcomes

    Primary Outcome Measures

    10cm VAS of pain(Dysmenorrhea)

    Secondary Outcome Measures

    quality of life (SF-36)

    Full Information

    First Posted
    February 11, 2009
    Last Updated
    September 23, 2009
    Sponsor
    Healingstone Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00842881
    Brief Title
    A Trial for Evaluation of Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea
    Acronym
    Healingstone
    Official Title
    Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2008 (undefined)
    Primary Completion Date
    March 2009 (Anticipated)
    Study Completion Date
    September 2009 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Healingstone Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether Healing stone navel belt is safe and effective in the treatment of Primary Dysmenorrhea.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Dysmenorrhea
    Keywords
    Healingstone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    102 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    a
    Arm Type
    No Intervention
    Arm Description
    healingstone
    Arm Title
    b
    Arm Type
    No Intervention
    Arm Description
    stone powder
    Intervention Type
    Device
    Intervention Name(s)
    Healingstone navel belt
    Other Intervention Name(s)
    Serial Number : HS-402
    Intervention Description
    6~8hours/day for 3months
    Primary Outcome Measure Information:
    Title
    10cm VAS of pain(Dysmenorrhea)
    Time Frame
    5months
    Secondary Outcome Measure Information:
    Title
    quality of life (SF-36)
    Time Frame
    7months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age : female adults aged 15~45 years Subjects should diagnosed as primary dysmenorrhea, should have a primary dysmenorrhea at least a 1-day during menstrual. Subjects should have 21~42 days menstrual cycle. menstrual pain : primary dysmenorrhea at least a 1-day during menstruation is over 5 VAS(Visual Analogue Scale) without drug. Subjects must have no Serious internal medicine. Subjects must provide signed informed consent prior to participation in any study-related procedures Exclusion Criteria: Subject that oral contraceptive taken within 3 months Pregnancy or lactation. Subject have contraceptive that secrete hormone. Secondary dysmenorrhea pelvis inflammatory disease patient Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    EungGi Min, MD
    Organizational Affiliation
    DongGuk University Hosipital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Trial for Evaluation of Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea

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