Menopause Clinical Trial
Official title:
A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women
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.
- 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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