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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Farabloc | Experimental | The participants will sleep on Farabloc fabric nightly for a week. |
|
| Nylon Fabric | Placebo Comparator | The participants will sleep on Nylon fabric nightly for week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Farabloc | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of hot flashes | The number of hot flashes subjects experienced in the past 24 hours | in the past 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of hot flash | An overall severity rating of hot flashes using a 10 point numeric scale 0 (not at all ) to 10 (extremely) | In the past 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| York N Hsiang, MB FRCSC | Contact | 604.876.5882 | york.hsiang@vch.ca | |
| Rollin Y Yu | Contact | 778.321.7921 | rollinyu@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| York N Hsiang, MB FRCSC | University of British Columbia, Division of Vascular Surgery and Vancouver General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Hsiang's office, 510-943 W. Broadway | Recruiting | Vancouver | British Columbia | V5Z 1K3 | Canada |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Nylon Fabric | Device | 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. |
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