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Completed

NCT Number: NCT01449305

Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea

To evaluate the mean change in menstrual pain intensity during menstrual cycles from baseline after wearing Nanoone Woman Underwear in women with primary dysmenorrhea

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Key information

Conditions

Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

13 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

PingTung Christian Hospital

Pingtung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nanoone Woman Underwear

Device

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chen Yi Enterprise, Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 10, 2011
Registry last updated
Feb 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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