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

Overview

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

Full Title of Study: “Comparison of the Effects of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 20, 2019

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.

Interventions

  • Procedure: acupuncture
    • 12 sessions acupuncture during 12 weeks (3 sessions weekly), each session lasting 20 minutes
  • Drug: fluoxetine
    • 10 mg/ daily

Arms, Groups and Cohorts

  • Experimental: Acupuncture
    • 12 sessions of acupuncture / 3 sessions weekly/ 20 minutes each session
  • Active Comparator: fluoxetine
    • 10 mg daily

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Gonabad University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Narjes Bahri, Instructor of midwifery education – Gonabad University of Medical Sciences
  • Overall Official(s)
    • Narjes Bahri, PhD Student, Principal Investigator, Gonabad University of Medical Sciences

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