Clinical trial NCT02006238: A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women
Official title: A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Menopause
Keywords: Hot flash
Farabloc
menopausal women
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: Fifty menopausal volunteers will be randomly assigned to two groups, one receiving Farabloc fabric containing Farabloc (experimental), and the other a similar-appearing fabric made of Nylon (placebo).

All eligible participants will be selected by the initial interview. The following information will be collected during interview process.

* Address
* Medical history
* Concomitant medication
* Allergies

Participants will be asked the following:

1. On a scale from 1 to 10, how much are you bothered by your hot flashes?
2. Do these hot flashes wake you up at night? Around how many times do they occur at night?
3. What are you expectations about this study?

A Menopause Rating Scale questionnaire will be completed by the potential participant to assess symptoms Eligible patients from each group will initially undergo a 7 day washout period before intervention in order to eliminate any effects of hormone replacement therapies (HRT) or herbal supplements that subjects may be using prior to participation in the study. Subjects will be randomized to receive a Farabloc fabric or placebo fabric for one week. After this, the two groups will undergo a second 7 day washout period before crossing over to the other fabric. Once crossed over, participants will use the allocated fabrics for another week.

Participants will be asked not to take their usual HRT or herbal supplements for the entire experimental duration in this study in order to produce impartial, precise and reliable results.

The manufacturer will assign codes for placebo fabric or experimental Farabloc. The randomization code will be broken at the completion of the study for data analysis.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of hot flashes
timeFrame: in the past 24 hours
Secondary outcomes:
measure: Severity of hot flash
timeFrame: In the past 24 hours
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Dr. Hsiang's office, 510-943 W. Broadway
state: British Columbia
Study officials:
affiliation: University of British Columbia, Division of Vascular Surgery and Vancouver General Hospital
name: York N Hsiang, MB FRCSC
role: PRINCIPAL_INVESTIGATOR
References: