Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea

Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449305
• Other study ID #: Nanoone
• Status: Completed
• Phase: N/A
• First received: October 6, 2011
• Last updated: February 1, 2013
• Start date: October 2011
• Est. completion date: June 2012

Study information

• Verified date: August 2011
• Source: Chen Yi Enterprise, Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 40 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Taiwan	PingTung Christian Hospital	Pingtung

Sponsors (1)

Lead Sponsor	Collaborator
Chen Yi Enterprise, Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medicine Administration for Pain Relief During Study Period	Continue taking pharmacological pain relief if required for subjects was allowed during study period, and it had been recorded.	first menstrual cycle, second menstrual cycle and third menstrual cycle	No
Primary	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	No