Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 10, 2014
First Posted Date  ICMJE July 11, 2014
Last Update Posted Date February 15, 2019
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
Quality of life in menopausal women [ Time Frame: 3 months after start sampling ]
Quality of life using MENQOL questionnaire
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
Quality of life [ Time Frame: 3 months after start sampling ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women
Official Title  ICMJE Comparison of the Effects of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women
Brief Summary The purpose of this study is to comparison the effect of acupuncture and Fluoxetine on improvement quality of life among menopausal women.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Hot Flash
  • Quality of Life
Intervention  ICMJE
  • Procedure: acupuncture
    12 sessions acupuncture during 12 weeks (3 sessions weekly), each session lasting 20 minutes
    Other Name: Manual acupuncture
  • Drug: fluoxetine
    10 mg/ daily
    Other Name: flouxetine
Study Arms  ICMJE
  • Experimental: Acupuncture
    12 sessions of acupuncture / 3 sessions weekly/ 20 minutes each session
    Intervention: Procedure: acupuncture
  • Active Comparator: fluoxetine
    10 mg daily
    Intervention: Drug: fluoxetine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 10, 2014)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188225
Other Study ID Numbers  ICMJE GMU.REC.1393.56
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Narjes Bahri, Gonabad University of Medical Sciences
Study Sponsor  ICMJE Gonabad University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Narjes Bahri, PhD Student Gonabad University of Medical Sciences
PRS Account Gonabad University of Medical Sciences
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP