Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Chen Yi Enterprise, Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01449305

First received: October 6, 2011

Last updated: February 1, 2013

Last verified: August 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 6, 2011
Last Updated Date	February 1, 2013
Start Date ^ICMJE	October 2011
Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 28, 2012)	The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline [ Time Frame: baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle ] [ Designated as safety issue: No ] The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain).
Original Primary Outcome Measures ^ICMJE (submitted: October 7, 2011)	The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain) [ Time Frame: At least 70 days ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01449305 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE (submitted: December 28, 2012)	Medicine Administration for Pain Relief During Study Period [ Time Frame: first menstrual cycle, second menstrual cycle and third menstrual cycle ] [ Designated as safety issue: No ] Continue taking pharmacological pain relief if required for subjects was allowed during study period, and it had been recorded.
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
Official Title ^ICMJE	Research on Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research
Condition ^ICMJE	Dysmenorrhea
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: 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. Intervention: Device: Nanoone Woman Underwear
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	44
Completion Date	June 2012
Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	13 Years to 40 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Taiwan

Administrative Information
NCT Number ^ICMJE	NCT01449305
Other Study ID Numbers ^ICMJE	Nanoone
Has Data Monitoring Committee	Not Provided
Responsible Party	Chen Yi Enterprise, Co., Ltd.
Study Sponsor ^ICMJE	Chen Yi Enterprise, Co., Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Chen Yi Enterprise, Co., Ltd.
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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