Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea

Study Overview
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Brief Summary
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To evaluate the mean change in menstrual pain intensity during menstrual cycles from baseline after wearing Nanoone Woman Underwear in women with primary dysmenorrhea

Detailed Description
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The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain). Subjects will be asked to use the VAS scoring system to record, on a provided sheet, their experienced menstrual pain level daily during menstrual bleeding for a total of three consecutive menstrual cycles.

Official Title
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Research on Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea

Conditions
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Dysmenorrhea

Intervention / Treatment
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* Device: Nanoone Woman Underwear


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females aged below 40 years old. Screened by inquiry and diagnosed as primary dysmenorrhea by gynaecologist with pelvic ultrasonography. Female subject who is: using adequate contraception since last menstruation and no plan for conception during the study. non-lactating. has negative pregnancy test (urine) within 14 days prior to the study. Informed consent form signed. Exclusion Criteria: Sensitivity to study product. Patient has been diagnosed with secondary dysmenorrhea (defined as identifiable pelvic pathology). Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co-investigator. Participation of any clinical investigation during the last 30 days.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nanoone Woman Underwear<br>Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. | Device: Nanoone Woman Underwear<br>* Chen Yi Enterprise, Co., Ltd. design a kind of negative ion materials can supply delocalized electron, and add fiber inside, make clothes to wear in the body, no external power or battery, only depend on infrared body photon hit of thermoelectric effect or heart compression pulse, blood flow of piezoelectric, therefore can sustained sufficient amount of effective negative ion, to eliminate positive ions in vivo, or make oxygen free radical to obtain the lack electrons. Decrease active free radical and get non toxic effect in short time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline | The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain). | baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle |