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To evaluate the mean change in menstrual pain intensity during menstrual cycles from baseline after wearing Nanoone Woman Underwear in women with primary dysmenorrhea
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nanoone Woman Underwear | Experimental | "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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | first menstrual cycle, second menstrual cycle and third menstrual cycle |
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:
Informed consent form signed.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PingTung Christian Hospital | Pingtung City | Taiwan |
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).
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Mean | Standard Deviation | scores | baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle |
|
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mirror Hsieh | isRed Pharma & Biotech Research Corporation | 886-8-7628188 | mingrong@bioisred.com |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | It was analyzed based on the PP population. | Posted | Number | percentage of participants | first menstrual cycle, second menstrual cycle and third menstrual cycle |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Title | Measurements |
|---|---|
|