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A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women (Flash)

Primary Purpose

Menopause

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Farabloc
Nylon Fabric
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause focused on measuring Hot flash, Farabloc, menopausal women

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr. Hsiang's office, 510-943 W. BroadwayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Farabloc

Nylon Fabric

Arm Description

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

The participants will sleep on Nylon fabric nightly for week.

Outcomes

Primary Outcome Measures

Frequency of hot flashes
The number of hot flashes subjects experienced in the past 24 hours

Secondary Outcome Measures

Severity of hot flash
An overall severity rating of hot flashes using a 10 point numeric scale 0 (not at all ) to 10 (extremely)

Full Information

First Posted
December 4, 2013
Last Updated
June 19, 2014
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02006238
Brief Title
A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women
Acronym
Flash
Official Title
A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: On a scale from 1 to 10, how much are you bothered by your hot flashes? Do these hot flashes wake you up at night? Around how many times do they occur at night? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause
Keywords
Hot flash, Farabloc, menopausal women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Farabloc
Arm Type
Experimental
Arm Description
The participants will sleep on Farabloc fabric nightly for a week.
Arm Title
Nylon Fabric
Arm Type
Placebo Comparator
Arm Description
The participants will sleep on Nylon fabric nightly for week.
Intervention Type
Device
Intervention Name(s)
Farabloc
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Nylon Fabric
Intervention Description
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 Information:
Title
Frequency of hot flashes
Description
The number of hot flashes subjects experienced in the past 24 hours
Time Frame
in the past 24 hours
Secondary Outcome Measure Information:
Title
Severity of hot flash
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
York N Hsiang, MB FRCSC
Phone
604.876.5882
Email
york.hsiang@vch.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Rollin Y Yu
Phone
778.321.7921
Email
rollinyu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
York N Hsiang, MB FRCSC
Organizational Affiliation
University of British Columbia, Division of Vascular Surgery and Vancouver General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Hsiang's office, 510-943 W. Broadway
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1K3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
York N Hsiang, MB FRCSC
Phone
604.876.5882
Email
york.hsiang@vch.ca
First Name & Middle Initial & Last Name & Degree
Rollin Y Yu

12. IPD Sharing Statement

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A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women

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