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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02006238
First received: December 4, 2013
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Menopause
Device: Farabloc
Device: Nylon Fabric

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Frequency of hot flashes [ Time Frame: in the past 24 hours ] [ Designated as safety issue: No ]
    The number of hot flashes subjects experienced in the past 24 hours


Secondary Outcome Measures:
  • Severity of hot flash [ Time Frame: In the past 24 hours ] [ Designated as safety issue: No ]
    An overall severity rating of hot flashes using a 10 point numeric scale 0 (not at all ) to 10 (extremely)


Estimated Enrollment: 50
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Farabloc
The participants will sleep on Farabloc fabric nightly for a week.
Device: Farabloc
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.
Device: Nylon Fabric
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.
Placebo Comparator: Nylon Fabric
The participants will sleep on Nylon fabric nightly for week.
Device: Farabloc
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.
Device: Nylon Fabric
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.

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

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006238

Contacts
Contact: York N Hsiang, MB FRCSC 604.876.5882 york.hsiang@vch.ca
Contact: Rollin Y Yu 778.321.7921 rollinyu@hotmail.com

Locations
Canada, British Columbia
Dr. Hsiang's office, 510-943 W. Broadway Recruiting
Vancouver, British Columbia, Canada, V5Z 1K3
Contact: York N Hsiang, MB FRCSC    604.876.5882    york.hsiang@vch.ca   
Sub-Investigator: Rollin Y Yu         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: York N Hsiang, MB FRCSC University of British Columbia, Division of Vascular Surgery and Vancouver General Hospital
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02006238     History of Changes
Other Study ID Numbers: H13-03052
Study First Received: December 4, 2013
Last Updated: June 19, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Hot flash
Farabloc
menopausal women

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014