A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women
NCT ID: NCT02006238
Last Updated: 2014-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2014-02-28
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Stellate Ganglion Nerve Block in Treating Women With Hot Flashes
NCT00879164
FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms
NCT05312567
Studying the Impact of Exercise on Hot Flashes
NCT03236896
A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause
NCT05033886
Venlafaxine and Hypnosis or Focused Attention in Treating Patients with Hot Flashes
NCT01000623
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Farabloc
The participants will sleep on Farabloc fabric nightly for a week.
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.
Nylon Fabric
The participants will sleep on Nylon fabric nightly for week.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Experiencing more than 2 nocturnal hot flashes nightly.
Exclusion Criteria
* 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.
45 Years
60 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
York N Hsiang, MB FRCSC
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia, Division of Vascular Surgery and Vancouver General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dr. Hsiang's office, 510-943 W. Broadway
Vancouver, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H13-03052
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.