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NCT02188225 Clinical Trial

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

Quality of Life Clinical Trial

Official title:
Comparison of the Effects of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02188225
Other study ID # GMU.REC.1393.56
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date December 2019

Study information
Verified date February 2019
Source Gonabad University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 140
Est. completion date December 2019
Est. primary completion date February 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Iran, Islamic Republic of Gonabad University of Medical Sciences Gonabad Khorasan Razavi
Iran, Islamic Republic of Narjes Bahri Mashhad Razavi Hkorasan Privience

Sponsors (1)
Lead Sponsor Collaborator
Gonabad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life in menopausal women Quality of life using MENQOL questionnaire 3 months after start sampling
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