Comparison of Acupuncture and Fluoxetine on Quality of Li... | NCT02188225

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

NCT02188225

Sponsor

Gonabad University of Medical Sciences

Status

Unknown status

Last Update Posted

Feb 15, 2019Actual

Enrollment

140Estimated

Phase

Not Applicable

Conditions

Hot Flash
Quality of Life

Interventions

acupuncture
fluoxetine

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Feb 20, 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Jul 10, 2014

First Submission Date that Met QC Criteria

Jul 10, 2014

First Posted Date

Jul 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2019

Last Update Posted Date

Feb 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Narjes Bahri, Instructor of midwifery education, Gonabad University of Medical SciencesPrincipal Investigator

Lead Sponsor

Gonabad University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acupuncture	Experimental	12 sessions of acupuncture / 3 sessions weekly/ 20 minutes each session	Procedure: acupuncture
fluoxetine	Active Comparator	10 mg daily	Drug: fluoxetine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
acupuncture	Procedure	12 sessions acupuncture during 12 weeks (3 sessions weekly), each session lasting 20 minutes	Acupuncture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life in menopausal women	Quality of life using MENQOL questionnaire	3 months after start sampling

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Narjes Bahri, PhD Student	Gonabad University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Narjes Bahri		Mashhad	Razavi Hkorasan Privience		Iran
Gonabad University of Medical Sciences

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019584	Hot Flashes

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015670	Acupuncture Therapy
D005473	Fluoxetine

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics
D011437	Propylamines
D000588	Amines

Browse Leaves

Not provided

Browse Branches

Not provided