An interventional study of Farabloc and Nylon Fabric in Menopause, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to female participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-06-23.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
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.
Participants will be asked the following:
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.
285 studies on the registry are indexed under Hot Flashes; 50 are open to participants now.
This study's planned enrollment of 50 is below the median of 90 across 255 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The participants will sleep on Farabloc fabric nightly for a week.
Device: Farabloc · Device: Nylon Fabric
The participants will sleep on Nylon fabric nightly for week.
Device: Farabloc · Device: Nylon Fabric
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.
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.
Frequency of hot flashes
The number of hot flashes subjects experienced in the past 24 hours
Time frame: in the past 24 hours
Severity of hot flash
An overall severity rating of hot flashes using a 10 point numeric scale 0 (not at all ) to 10 (extremely)
Time frame: In the past 24 hours
This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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University of British Columbia