Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea

• ClinicalTrials.gov Identifier: NCT01449305
• Recruitment Status: Completed
• First Posted: October 10, 2011
• Results First Posted: February 1, 2013
• Last Update Posted: February 4, 2013
• Sponsor: Chen Yi Enterprise, Co., Ltd.
• Information provided by (Responsible Party): Chen Yi Enterprise, Co., Ltd.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Dysmenorrhea	Device: Nanoone Woman Underwear	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Research on Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
• Study Start Date: October 2011
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm

Intervention/treatment

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.

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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain).

Other Outcome Measures:

1. Medicine Administration for Pain Relief During Study Period [ Time Frame: first menstrual cycle, second menstrual cycle and third menstrual cycle ]
   Continue taking pharmacological pain relief if required for subjects was allowed during study period, and it had been recorded.

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 40 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Taiwan

PingTung Christian Hospital

Pingtung, Taiwan

Sponsors and Collaborators

Chen Yi Enterprise, Co., Ltd.

More Information

• Responsible Party: Chen Yi Enterprise, Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01449305
• Other Study ID Numbers: Nanoone
• First Posted: October 10, 2011
• Results First Posted: February 1, 2013
• Last Update Posted: February 4, 2013
• Last Verified: August 2011

Additional relevant MeSH terms:

Dysmenorrhea; Menstruation Disturbances; Pathologic Processes; Pelvic Pain; Pain; Neurologic Manifestations