Status:
UNKNOWN
A Trial for Evaluation of Clinical Efficacy and Safety of Healing Stone Navel Belt in Patients With Primary Dysmenorrhea
Lead Sponsor:
Healingstone Co., Ltd.
Conditions:
Primary Dysmenorrhea
Eligibility:
FEMALE
15-45 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00842881
Start Date
August 1 2008
End Date
September 1 2009
Last Update
September 24 2009
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