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
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Healingstone
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.
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
NCT ID
NCT00842881
First Posted
February 11, 2009
Last Updated
September 23, 2009
Sponsor
Healingstone Co., Ltd.
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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