Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea

NCT01449305 | Completed Results

• 1 other identifier: Nanoone
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Medicine Administration for Pain Relief During Study Period

  first menstrual cycle, second menstrual cycle and third menstrual cycle

Study Arms (1)

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.

Device: Nanoone Woman Underwear

Interventions

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.

Nanoone Woman Underwear

Eligibility Criteria

• Age: 13 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chen Yi Enterprise, Co., Ltd.: lead

Study Sites (1)

PingTung Christian Hospital

Pingtung City, Taiwan

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Mirror Hsieh
• Organization: isRed Pharma & Biotech Research Corporation

mingrong@bioisred.com

886-8-7628188

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 10, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 4, 2013
• Results First Posted: February 1, 2013

Record last verified: 2011-08

Locations

TW (1)