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The Comparison of the Effect of Omega3 and Folic Acid Oral Tablet on Hot Flashes in Menopausal Women

Protocol summary

Summary
Objective: The Comparison of the Effect of Omega3 and Folic Acid Oral Tablet on Hot Flashes in Menopausal Women(2) Study design: The sampling will be random and triple blind. This study will be placebo-controlled and single center. The study population : Iranian origin of all menopausal women with hot flashes,Sample size: 120 (3): In this semi-experimental study will participate 120 menopausal women with hot flashes (4): Inclusion criteria : Iranian, age 45-60 years, menopause is the normal type have,reporting at least two times hot flashes per day , with literacy being studied components or a family member, body mass index 20 to 30, non receiving hormone therapy , anti-depressants or tranquilizers, supplements and herbal medicines, no known underlying disease (hypertension, diabetes, epilepsy, etc.), the lack of experience of such as relatives died in the last 6 months of stress, separation of spouses and absence of estrogen-dependent cancer, non consumption of more than 2 servings of fish per weeks, insensitivity to fish or fish oil, seafood, avoiding the use of any drugs to improve the symptoms of hot flashes, at least one year and a maximum of three years have menstruation, exercise not more than 2 times a week for 20-30Dqyqh,Exclusion criteria: the other drug use during the study, in case of complications or allergic drugs (omega-3 or folic acid), identifying any physical or mental illness during the study, lack of proper use of drugs or placebo over three days (5) Intervention: They are divided into three groups. Group 1: omega3 1 tablet 1000 mg daily, group 2: folic acid 1 tablet 1 mg daily, group 3: placebo 1tablet daily, for three months (6) Primary outcome measure:Intensity, duration and frequency of hot flashes

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011131880N1
Registration date: 2017-01-24, 1395/11/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-24, 1395/11/05
Registrant information
Name
masoumeh chamani
Name of organization / entity
دانشگاه علوم پزشکی ایران
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
chamani.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the Effect of Omega3 and Folic Acid Oral Tablet on Hot Flashes in Menopausal Women
Public title
The Comparison of the Effect of Omega3 and Folic Acid Oral Tablet on Hot Flashes in Menopausal Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Iranian, age 45-60 years, menopause is the normal type have,reporting at least two times hot flashes per day , with literacy being studied components or a family member, body mass index 20 to 30, non receiving hormone therapy , anti-depressants or tranquilizers, supplements and herbal medicines, no known underlying disease (hypertension, diabetes, epilepsy, etc.), the lack of experience of such as relatives died in the last 6 months of stress, separation of spouses and absence of estrogen-dependent cancer, non consumption of more than 2 servings of fish per weeks, insensitivity to fish or fish oil, seafood, avoiding the use of any drugs to improve the symptoms of hot flashes, at least one year and a maximum of three years have menstruation, exercise not more than 2 times a week for 20-30Dqyqh,Exclusion criteria: the other drug use during the study, in case of complications or allergic drugs (omega-3 or folic acid), identifying any physical or mental illness during the study, lack of proper use of drugs or placebo over three days
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: Sample allocation in the case and control group will be conducted randomly and using lottery through numbering 1, 2 and 3 on the cards. The samples will be asked to pick a card. By choosing a card, randomly the sample will be placed in one of the following groups: Group Evening omega3 (1 tablet 1000 mg daily), folic acid (1 tablet 1 mg daily) and placebo groups (1 capsules daily) Blinding:the medicine( omega3 and folic acid) and placebo in the form of similar tablet will be produced by pharmacology advisor. Also putting capsules in the same containers and coding them will be performed by him. And at the end of the study and after analyzing the results, the tablet containers will be decoded. Thus, the samples are not aware of the contents of the medicine containers. As well as researchers and statistical analysts are not aware of the contents of the medicine containers and each groups What medications are taking. So, the study is a triple-blind

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran
City
tehran
Postal code
1996713883
Approval date
2016-08-08, 1395/05/18
Ethics committee reference number
IR. IUMS. REC 1395 - 9311373012

Health conditions studied

1

Description of health condition studied
menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states

Primary outcomes

1

Description
The severity of hot flashes
Timepoint
Before the intervention, one month and two months and three months after intervention
Method of measurement
Daily hot flash diary form

Secondary outcomes

1

Description
duration of hot flashes
Timepoint
Before the intervention, one month and two months and three months after intervention
Method of measurement
Daily hot flash diary form

2

Description
Frequency hot flashes
Timepoint
Before the intervention, one month and two months and three months after intervention
Method of measurement
Daily hot flash diary form

Intervention groups

1

Description
Intervention group:omega3 1 tablet 1000 mg daily, group folic acid 1 tablet 1 mg daily،omega3 is made zahravi , folic acid made Shahid Beheshti University of Medical Science in the School of Pharmacy
Category
Placebo

2

Description
Control group: placebo 1 tablet daily for 3 months , made School of Pharmacy Shahid, Beheshti University of Medical Sciences
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
north west public health centers affliated Iran University of Medical Sciences
Full name of responsible person
Zahra Keshavarzian
Street address
60/5000 Ministers street, opposite the cinema release, North West of Tehran Health Center
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Morteza Naser Bakhat
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
masoumeh chamani
Position
Master student of midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran
City
tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
Email
m66.chamani@gmail.comchamani.m@tak.iums.ac.ir
Web page address
www.iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Medical Sciences Iran, School of Nursing and Midwifery
Full name of responsible person
Fereshteh Jahdi
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran
City
tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
+98 912 188 9185
Email
jahdi_fr@yahoo.com
Web page address
www.iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Medical Sciences Iran, School of Nursing and Midwifery
Full name of responsible person
masoumeh chamani
Position
Master Student Of Midwifery
Other areas of specialty/work
Street address
Rastvan Street, Pasdaran Street, Tehran
City
tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
Email
chamani.m@tak.iums.ac.ir
Web page address
www.iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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