ClinicalTrials.gg
Status unknownNCT02188225Updated Feb 15, 2019

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

An interventional study of acupuncture and fluoxetine in Hot Flash and Quality of Life, sponsored by Gonabad University of Medical Sciences. Status unknown at 2 sites in Iran, Islamic Republic of. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Gonabad University of Medical Sciences · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hot Flash
  • Quality of Life

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Keywords

  • Hot flash
  • Acupuncture
  • Fluoxetine
  • Quality of life
03

In context

Hot Flashes

339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.

This study's planned enrollment of 140 is above the median of 90 across 306 interventional studies indexed under Hot Flashes.

Browse Hot Flashes studies →

Lead sponsor

Gonabad University of Medical Sciences is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Not completing all acupuncture sessions
  • Not completing fluoxetine admission
  • Withdraw the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Acupuncture

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

    Procedure: acupuncture

  • Active comparator
    fluoxetine

    10 mg daily

    Drug: fluoxetine

Interventions

  • Procedureacupuncture

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

    Also known as: Manual acupuncture

  • 10 mg/ daily

    Also known as: flouxetine

06

What researchers measure

Primary outcomes

  1. Quality of life in menopausal women

    Quality of life using MENQOL questionnaire

    Time frame: 3 months after start sampling

07

Study locations

2 sites
  • Gonabad University of Medical Sciences
    Gonabad, Khorasan Razavi, Iran, Islamic Republic of
  • Narjes Bahri
    Mashhad, Razavi Hkorasan Privience, Iran, Islamic Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2014, a primary completion of Feb 2019 and a completion of Dec 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 10, 2014
First posted
Jul 11, 2014
Start
Jul 2014
Primary completionEst.
Feb 20, 2019
CompletionEst.
Dec 2019
Last update
Feb 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02188225
Lead sponsor
Gonabad University of Medical Sciences
Responsible party
Narjes Bahri (Instructor of midwifery education, Gonabad University of Medical Sciences) — Principal investigator
First posted
Jul 11, 2014
Start date
Jul 2014
Primary completion
Feb 20, 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Feb 15, 2019

Study contacts

Narjes Bahri, PhD Student
principal investigator · Gonabad University of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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