NCT02188225

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

4.6 years

First QC Date

July 10, 2014

Last Update Submit

February 13, 2019

Conditions

Hot FlashQuality of Life

Keywords

Hot flashAcupunctureFluoxetineQuality of life

Outcome Measures

Primary Outcomes (1)

  • Quality of life in menopausal women

    Quality of life using MENQOL questionnaire

    3 months after start sampling

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Procedure: acupuncture

fluoxetine

ACTIVE COMPARATOR

10 mg daily

Drug: fluoxetine

Interventions

acupuncturePROCEDURE

12 sessions acupuncture during 12 weeks (3 sessions weekly), each session lasting 20 minutes

Also known as: Manual acupuncture
Acupuncture
fluoxetineDRUG

10 mg/ daily

Also known as: flouxetine
fluoxetine

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Last menstrual cycle 12 months ago
  • natural menopause
  • 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

You may not qualify if:

  • Not completing all acupuncture sessions
  • Not completing fluoxetine admission
  • Withdraw the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gonabad University of Medical Sciences

Gonābād, Khorasan Razavi, Iran

Location

Narjes Bahri

Mashhad, Razavi Hkorasan Privience, Iran

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Acupuncture TherapyFluoxetine

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPropylaminesAminesOrganic Chemicals

Study Officials

  • Narjes Bahri, PhD Student

    Gonabad University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor of midwifery education

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 11, 2014

Study Start

July 1, 2014

Primary Completion

February 20, 2019

Study Completion

December 1, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

IR(2)