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
  Purpose

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 Intervention
Dysmenorrhea
Device: Nanoone Woman Underwear

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Research on Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea

Resource links provided by NLM:


Further study details as provided by Chen Yi Enterprise, Co., Ltd.:

Primary Outcome Measures:
  • 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).


Other Outcome Measures:
  • 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.


Enrollment: 44
Study Start Date: October 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   13 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449305

Locations
Taiwan
PingTung Christian Hospital
Pingtung, Taiwan
Sponsors and Collaborators
Chen Yi Enterprise, Co., Ltd.
  More Information

No publications provided

Responsible Party: Chen Yi Enterprise, Co., Ltd.
ClinicalTrials.gov Identifier: NCT01449305     History of Changes
Other Study ID Numbers: Nanoone
Study First Received: October 6, 2011
Results First Received: December 28, 2012
Last Updated: February 1, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014