Back to resultsEffectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Nanoone Woman Underwear
Sponsored by
About this trial
This is an interventional health services research trial for Dysmenorrhea
Eligibility Criteria
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.
Sites / Locations
- PingTung Christian Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nanoone Woman Underwear
Arm Description
"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.
Outcomes
Primary Outcome Measures
The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline
The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain).
Secondary Outcome Measures
Full Information
NCT ID
NCT01449305
First Posted
October 6, 2011
Last Updated
February 1, 2013
Sponsor
Chen Yi Enterprise, Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01449305
Brief Title
Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
Official Title
Research on Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chen Yi Enterprise, Co., Ltd.
4. Oversight
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nanoone Woman Underwear
Arm Type
Experimental
Arm Description
"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 Type
Device
Intervention Name(s)
Nanoone Woman Underwear
Intervention Description
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 Outcome Measure Information:
Title
The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline
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).
Time Frame
baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle
Other Pre-specified Outcome Measures:
Title
Medicine Administration for Pain Relief During Study Period
Description
Continue taking pharmacological pain relief if required for subjects was allowed during study period, and it had been recorded.
Time Frame
first menstrual cycle, second menstrual cycle and third menstrual cycle
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
PingTung Christian Hospital
City
Pingtung
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
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