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

February 13, 2019 updated by: Narjes Bahri, Gonabad University of Medical Sciences

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Khorasan Razavi
      • Gonabad, Khorasan Razavi, Iran, Islamic Republic of
        • Gonabad University of Medical Sciences
    • Razavi Hkorasan Privience
      • Mashhad, Razavi Hkorasan Privience, Iran, Islamic Republic of
        • Narjes Bahri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
12 sessions of acupuncture / 3 sessions weekly/ 20 minutes each session
Procedure: acupuncture
12 sessions acupuncture during 12 weeks (3 sessions weekly), each session lasting 20 minutes
Other Names:
  • Manual acupuncture
Active Comparator: fluoxetine
10 mg daily
Drug: fluoxetine
10 mg/ daily
Other Names:
  • flouxetine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life in menopausal women
Time Frame: 3 months after start sampling
Quality of life using MENQOL questionnaire
3 months after start sampling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gonabad University of Medical Sciences

Investigators

  • Principal Investigator: Narjes Bahri, PhD Student, Gonabad University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

February 20, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

July 10, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMU.REC.1393.56

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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