Trial Outcomes & Findings for Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea (NCT NCT01449305)

Results Overview

The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle

Results posted on

2013-02-04

Participant Flow

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).

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).

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	44
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nanoone Woman Underwear n=44 Participants "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.
Age, Categorical <=18 years	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	22.4 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Taiwan	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain).

Outcome measures

Outcome measures
Measure	Nanoone Woman Underwear n=42 Participants "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.
The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline First menstrual cycle	-0.810 scores Standard Deviation 2.04
The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline Second menstrual cycle	-1.29 scores Standard Deviation 1.81
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 outcome

Timeframe: first menstrual cycle, second menstrual cycle and third menstrual cycle

Population: It was analyzed based on the PP population.

Continue taking pharmacological pain relief if required for subjects was allowed during study period, and it had been recorded.

Outcome measures

Outcome measures
Measure	Nanoone Woman Underwear n=42 Participants "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.
Medicine Administration for Pain Relief During Study Period First menstrual cycle	21.4 percentage of participants
Medicine Administration for Pain Relief During Study Period Second menstrual cycle	9.52 percentage of participants
Medicine Administration for Pain Relief During Study Period Third menstrual cycle	7.14 percentage of participants

Adverse Events

Nanoone Woman Underwear

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mirror Hsieh

isRed Pharma & Biotech Research Corporation

Phone: 886-8-7628188

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place