Hot FlashNCT02188225
Comparison of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women
A study testing acupuncture and fluoxetine in people with Hot Flash and Quality of Life, run by Gonabad University of Medical Sciences at 2 sites in Iran.
Trial summary
The purpose of this study is to comparison the effect of acupuncture and Fluoxetine on improvement quality of life among menopausal women. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flash, Quality of Life
- What is being tested?
- acupuncture and fluoxetine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesIran
- Study dates
- Jul 2014to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Last menstrual cycle 12 months ago
- natural menopause
- 4 episodes of hot flash daily
- follicle stimulating hormone (FSH)= 30-110 IU/L , E2<18pg/ml
- thyroid-stimulating hormone(TSH)= 0.4-4/0 IU/ml
- No using of herbal agent for treatment of hot flash
- having score in Beck depression Inventory<10
- No existence of any medical problems and using drugs
Who cannot join
- Not completing all acupuncture sessions
- Not completing fluoxetine admission
- Withdraw the study
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Gonabad University of Medical Sciences
Gonābād, Razavi Khorasan Province
Narjes Bahri
Mashhad, Razavi Hkorasan Privience
About this study
Official title: Comparison of the Effects of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women
The purpose of this study is to comparison the effect of acupuncture and Fluoxetine on improvement quality of life among menopausal women.
Read the detailed description
This clinical trial is designed in two arm include acupuncture and fluoxetine group to evaluate the effect of these intervention on improvement quality of life among menopausal women.
- Conditions
- Hot Flash, Quality of Life
- Being tested
- acupuncture, fluoxetine
- Keywords
- Hot flash, Acupuncture, Fluoxetine, Quality of life
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Also called Manual acupuncture
12 sessions acupuncture during 12 weeks (3 sessions weekly), each session lasting 20 minutes
fluoxetineDrug
Also called flouxetine
10 mg/ daily
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | 12 sessions of acupuncture / 3 sessions weekly/ 20 minutes each session Receives: Procedure: acupuncture |
| fluoxetine | Active comparator | 10 mg daily Receives: Drug: fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life in menopausal women
Quality of life using MENQOL questionnaire
Measured: 3 months after start sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJul 2014
- Primary completion20 Feb 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gonabad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narjes Bahri, Gonabad University of Medical Sciences
- Investigators
- Narjes Bahri, PhD Student, Principal investigator, Gonabad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188225
- Sponsor's protocol ID
- GMU.REC.1393.56
- Status last verified
- Feb 2019
- First submitted
- 10 Jul 2014
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women
- ClinicalTrials.gov ID
- NCT02188225
- Acronym / sponsor ID
- GMU.REC.1393.56
- Conditions
- Hot Flash, Quality of Life
- Keywords
- Hot flash, Acupuncture, Fluoxetine, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Gonabad University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 20 Feb 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to comparison the effect of acupuncture and Fluoxetine on improvement quality of life among menopausal women.
Detailed description
This clinical trial is designed in two arm include acupuncture and fluoxetine group to evaluate the effect of these intervention on improvement quality of life among menopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: acupuncture12 sessions of acupuncture / 3 sessions weekly/ 20 minutes each session |
| fluoxetine | Active comparator | Drug: fluoxetine10 mg daily |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Last menstrual cycle 12 months ago
- natural menopause
- 4 episodes of hot flash daily
- follicle stimulating hormone (FSH)= 30-110 IU/L , E2<18pg/ml
- thyroid-stimulating hormone(TSH)= 0.4-4/0 IU/ml
Key exclusion criteria (3 listed)
- Not completing all acupuncture sessions
- Not completing fluoxetine admission
- Withdraw the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureAlso: Manual acupuncture12 sessions acupuncture during 12 weeks (3 sessions weekly), each session lasting 20 minutes | Procedure or surgery | Acupuncture |
| fluoxetineAlso: flouxetine10 mg/ daily | Drug | fluoxetine |
Primary outcome
Quality of life in menopausal women
Time frame: 3 months after start sampling
Quality of life using MENQOL questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Narjes Bahri, PhD Student principal investigator
Gonabad University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and fluoxetine in people with Hot Flash and Quality of Life, run by Gonabad University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life in menopausal women (time frame: 3 months after start sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.