Primary Dysmenorrhea
Conditions
Keywords
Healingstone
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.
Interventions
DEVICEHealingstone navel belt
6\ 8hours/day for 3months
Sponsors
Healingstone Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 10cm VAS of pain(Dysmenorrhea) | 5months |
Secondary
| Measure | Time frame |
|---|---|
| quality of life (SF-36) | 7months |
Outcome results
None listed