Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea

Chen Yi Enterprise

Status: Completed

Conditions: Dysmenorrhea

Treatments: Device: Nanoone Woman Underwear

Study type: Interventional

Funder types: Industry

Identifiers

NCT01449305

Nanoone

Details and patient eligibility

About

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

Full description

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.

Enrollment: 44 patients

Sex: Female

Ages: 13 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Females aged below 40 years old.

2. Screened by inquiry and diagnosed as primary dysmenorrhea by gynaecologist with pelvic ultrasonography.

3. 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.

4. Informed consent form signed.

Exclusion criteria

1. Sensitivity to study product.
2. Patient has been diagnosed with secondary dysmenorrhea (defined as identifiable pelvic pathology).
3. Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co-investigator.
4. Participation of any clinical investigation during the last 30 days.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Nanoone Woman Underwear

Experimental group

Description:

"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.

Treatment:

Device: Nanoone Woman Underwear