Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea

Not Applicable

Completed

• Conditions: Dysmenorrhea
• Interventions: Device: Nanoone Woman Underwear

• Registration Number: NCT01449305
• Lead Sponsor: Chen Yi Enterprise, Co., Ltd.

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 Timeline

• Status Verified: 2011-08
• Study Start: 2011-10
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-10
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2012-12-28
• Results First Submitted QC: 2012-12-28
• Results First Posted: 2013-02-01
• Last Update Submitted: 2013-02-01
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nanoone Woman Underwear	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.

Primary Outcome Measures

Name	Time	Method
The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline	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).

Trial Locations

Locations (1)

PingTung Christian Hospital; 🇨🇳 Pingtung, Taiwan