CClinicalTrials.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this record recently (last verified Feb 2019), so the status shown — last known as Enrolling by invitation — may be out of date.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

Browse trials for

Keywords

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

Who can participate

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

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
04

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

  • Drugfluoxetine

    10 mg/ daily

    Also known as: flouxetine

05

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

06

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
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion