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

Menopause Clinical Trial

— Flash  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02006238
• Other study ID #: H13-03052
• Status: Recruiting
• Phase: N/A
• First received: December 4, 2013
• Last updated: June 19, 2014
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2014
• Source: University of British Columbia
• Contact: York N Hsiang, MB FRCSC
• Phone: 604.876.5882
• Email: york.hsiang[@]vch.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Dr. Hsiang's office, 510-943 W. Broadway	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of hot flashes	The number of hot flashes subjects experienced in the past 24 hours	in the past 24 hours	No
Secondary	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	No