Comparison of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women

NCT ID: NCT02188225

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to comparison the effect of acupuncture and Fluoxetine on improvement quality of life among menopausal women.

Detailed Description

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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

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Hot Flash Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Acupuncture

12 sessions of acupuncture / 3 sessions weekly/ 20 minutes each session

Group Type EXPERIMENTAL

acupuncture

Intervention Type PROCEDURE

12 sessions acupuncture during 12 weeks (3 sessions weekly), each session lasting 20 minutes

fluoxetine

10 mg daily

Group Type ACTIVE_COMPARATOR

fluoxetine

Intervention Type DRUG

10 mg/ daily

Interventions

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acupuncture

12 sessions acupuncture during 12 weeks (3 sessions weekly), each session lasting 20 minutes

Intervention Type PROCEDURE

fluoxetine

10 mg/ daily

Intervention Type DRUG

Other Intervention Names

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Manual acupuncture flouxetine

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Not completing all acupuncture sessions
* Not completing fluoxetine admission
* Withdraw the study
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gonabad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Narjes Bahri

Instructor of midwifery education

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Narjes Bahri, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Gonabad University of Medical Sciences

Locations

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Gonabad University of Medical Sciences

Gonābād, Khorasan Razavi, Iran

Site Status

Narjes Bahri

Mashhad, Razavi Hkorasan Privience, Iran

Site Status

Countries

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Iran

Other Identifiers

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GMU.REC.1393.56

Identifier Type: -

Identifier Source: org_study_id

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