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

Sponsor
Gonabad University of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT02188225
Collaborator
(none)
140
Enrollment
2
Locations
2
Arms
65
Duration (Months)
70
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparison of the Effects of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women
Study Start Date :
Jul 1, 2014
Anticipated Primary Completion Date :
Feb 20, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Quality of life in menopausal women [3 months after start sampling]

      Quality of life using MENQOL questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gonabad University of Medical Sciences Gonabad Khorasan Razavi Iran, Islamic Republic of
    2 Narjes Bahri Mashhad Razavi Hkorasan Privience Iran, Islamic Republic of

    Sponsors and Collaborators

    • Gonabad University of Medical Sciences

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Narjes Bahri, Instructor of midwifery education, Gonabad University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT02188225
    Other Study ID Numbers:
    • GMU.REC.1393.56
    First Posted:
    Jul 11, 2014
    Last Update Posted:
    Feb 15, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Narjes Bahri, Instructor of midwifery education, Gonabad University of Medical Sciences
    Hot flash
    Acupuncture
    Fluoxetine
    Quality of life
    Additional relevant MeSH terms:
    Hot Flashes
    Fluoxetine

    Study Results

    No Results Posted as of Feb 15, 2019