Dysmenorrhea
Conditions
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.
Interventions
DEVICENanoone 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.
Sponsors
Chen Yi Enterprise, Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medicine Administration for Pain Relief During Study Period | 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. |
Countries
Taiwan
Participant flow
Recruitment details
Forty-four (44) subjects enrolled into the study. Forty-two (42) subjects completed the study from 2011-10-11 to 2012-06-23 at the PingTung Christian Hospital (60, Dallan Road, Pingtung, Taiwan).
Pre-assignment details
This is an Open-label study design. The subject must be qualified for the study by fulfilling all of the inclusion and none of the exclusion criteria. Laboratory values which are out of reference range will not qualify unless the physician deems the deviation not clinically significant (NCS).
Participants by arm
| Arm | Count |
|---|---|
| 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. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Nanoone Woman Underwear |
|---|---|
| Age, Categorical <=18 years | 3 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| Age Continuous | 22.4 years STANDARD_DEVIATION 4.2 |
| Region of Enrollment Taiwan | 44 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
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).
Time frame: baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle
Population: Subjects were 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 in house. Primary objective was analyzed based on the Per-protocol (PP) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nanoone Woman Underwear | The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline | First menstrual cycle | -0.810 scores | Standard Deviation 2.04 |
| Nanoone Woman Underwear | The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline | Second menstrual cycle | -1.29 scores | Standard Deviation 1.81 |
| Nanoone Woman Underwear | The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline | Third menstrual cycle | -1.74 scores | Standard Deviation 2.24 |
Other Pre-specified
Medicine Administration for Pain Relief During Study Period
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
Population: It was analyzed based on the PP population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nanoone Woman Underwear | Medicine Administration for Pain Relief During Study Period | First menstrual cycle | 21.4 percentage of participants |
| Nanoone Woman Underwear | Medicine Administration for Pain Relief During Study Period | Second menstrual cycle | 9.52 percentage of participants |
| Nanoone Woman Underwear | Medicine Administration for Pain Relief During Study Period | Third menstrual cycle | 7.14 percentage of participants |