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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01449305
Other study ID # Nanoone
Secondary ID
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


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
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