Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea

NCT ID: NCT01449305

Last Updated: 2013-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-06-30

Brief Summary

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

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.

Conditions

Dysmenorrhea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Nanoone Woman Underwear

"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.

Group Type: EXPERIMENTAL

Nanoone Woman Underwear

Intervention Type: DEVICE

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.

Interventions

Nanoone Woman Underwear

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chen Yi Enterprise, Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PingTung Christian Hospital

Pingtung City, , Taiwan

Countries

Taiwan

Other Identifiers

Nanoone

Identifier Type: -

Identifier Source: org_study_id