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

Primary Purpose

Hot Flash, Quality of Life

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
acupuncture
fluoxetine
Sponsored by
Gonabad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hot Flash focused on measuring Hot flash, Acupuncture, Fluoxetine, Quality of life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Gonabad University of Medical Sciences
  • Narjes Bahri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture

fluoxetine

Arm Description

12 sessions of acupuncture / 3 sessions weekly/ 20 minutes each session

10 mg daily

Outcomes

Primary Outcome Measures

Quality of life in menopausal women
Quality of life using MENQOL questionnaire

Secondary Outcome Measures

Full Information

First Posted
July 10, 2014
Last Updated
February 13, 2019
Sponsor
Gonabad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02188225
Brief Title
Comparison of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women
Official Title
Comparison of the Effects of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 20, 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gonabad University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flash, Quality of Life
Keywords
Hot flash, Acupuncture, Fluoxetine, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
12 sessions of acupuncture / 3 sessions weekly/ 20 minutes each session
Arm Title
fluoxetine
Arm Type
Active Comparator
Arm Description
10 mg daily
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Other Intervention Name(s)
Manual acupuncture
Intervention Description
12 sessions acupuncture during 12 weeks (3 sessions weekly), each session lasting 20 minutes
Intervention Type
Drug
Intervention Name(s)
fluoxetine
Other Intervention Name(s)
flouxetine
Intervention Description
10 mg/ daily
Primary Outcome Measure Information:
Title
Quality of life in menopausal women
Description
Quality of life using MENQOL questionnaire
Time Frame
3 months after start sampling

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narjes Bahri, PhD Student
Organizational Affiliation
Gonabad University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gonabad University of Medical Sciences
City
Gonabad
State/Province
Khorasan Razavi
Country
Iran, Islamic Republic of
Facility Name
Narjes Bahri
City
Mashhad
State/Province
Razavi Hkorasan Privience
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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