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

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ClinicalTrials.gov Identifier: NCT02188225
Recruitment Status : Unknown
Verified February 2019 by Narjes Bahri, Gonabad University of Medical Sciences.
Recruitment status was:  Enrolling by invitation
First Posted : July 11, 2014
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Narjes Bahri, Gonabad University of Medical Sciences

Study Description
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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
Hot Flash Quality of Life Procedure: acupuncture Drug: fluoxetine Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2014
Estimated Primary Completion Date : February 20, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arms and Interventions
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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 Name: Manual acupuncture
Active Comparator: fluoxetine
10 mg daily
 Drug: fluoxetine
10 mg/ daily
Other Name: flouxetine


Outcome Measures
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Primary Outcome Measures :
  1. Quality of life in menopausal women [ Time Frame: 3 months after start sampling ]
    Quality of life using MENQOL questionnaire


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188225


Locations
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Iran, Islamic Republic of
Gonabad University of Medical Sciences
Gonabad, Khorasan Razavi, Iran, Islamic Republic of
Narjes Bahri
Mashhad, Razavi Hkorasan Privience, Iran, Islamic Republic of
Sponsors and Collaborators
Gonabad University of Medical Sciences
Investigators
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Principal Investigator: Narjes Bahri, PhD Student Gonabad University of Medical Sciences
More Information
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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: July 11, 2014    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Narjes Bahri, Gonabad University of Medical Sciences:
Hot flash
Acupuncture
Fluoxetine
Quality of life
Additional relevant MeSH terms:
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Hot Flashes
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
 Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors