Recruiting

Farabloc Fabric

Sponsor:

University of British Columbia

Code:

NCT02006238

Conditions

Menopause

Eligibility Criteria

Sex: Female

Age: 45 - 60

Healthy Volunteers: Not accepted

Interventions

Farabloc

Nylon Fabric

Study Details

Brief summary:

This is a prospective, randomized, double-blind, crossover study. The purpose of this study is to determine whether Farabloc fabric is effective in alleviation of hot flash symptoms in menopausal women. This study will require all prospective participants to fill out a week of Hot Flash Diary to determine eligibility before beginning the study. All prospective participants will be assessed for hot flash frequency, hot flash distress and hot flash severity according to their perception in the Hot Flash Diary during the experimental period.

Conditions

Menopause

Study ID

NCT02006238

Start date

Feb, 2014

Status verified date

Jun, 2014

Completion date

Dec, 2014

Anticipated

Primary completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women with 12 months amenorrhea
  • Experiencing more than 2 nocturnal hot flashes nightly.

Exclusion Criteria:

  • Other medical conditions associated with night sweats
  • Currently on medication associated with night sweats
  • Less than 2 nocturnal hot flashes per night
  • Allergies to metals
  • Abnormal mental status
  • MRS scale rating of mild or above
  • Currently on hormone replacement therapy or herbal supplements and cannot safety discontinue these for the duration of the study.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Farabloc

The participants will sleep on Farabloc fabric nightly for a week.

placebo comparator: Nylon Fabric

The participants will sleep on Nylon fabric nightly for week.

Interventions

Farabloc

The participants will be randomly received Farabloc (experimental) for one week, followed by a 7 day washout and then crossed over to received the Nylon fabric (placebo) for one week.

Nylon Fabric

The participants will be randomly received Nylon fabric (placebo) for one week, followed by a 7 day washout and then crossed over to receive Farabloc (experimental) for one week.

Primary outcome measure

  • Frequency of hot flashes [ Time Frame: in the past 24 hours ]

Central Contacts and Locations

Central contacts

York N Hsiang, MB FRCSC

604.876.5882york.hsiang@vch.ca

Rollin Y Yu

778.321.7921rollinyu@hotmail.com

Locations

Dr. Hsiang's office, 510-943 W. Broadway

Recruiting

Vancouver, British Columbia, Canada, V5Z 1K3

Contacts

York N Hsiang, MB FRCSC

604.876.5882york.hsiang@vch.ca

More Information

Sponsor

University of British Columbia

Last update posted

Jun 23, 2014

Last verified

Jun, 2014

Keywords

  • Hot flash
  • Farabloc
  • menopausal women

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2014-06-23.