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The effect of oral capsule of curcumin and vitamin E on the hot flush and anxiety in postmenopausal women: a triple blind randomised controlled trial

Protocol summary

Study aim
To determine the effect of oral curcumin and vitamin E capsules on hot flush and anxiety in postmenopausal Women
Design
Randomized controlled clinical trial with three parallel arms.
Settings and conduct
This study will be performed on 93 menopausal women in Ahar city. The researcher will go to the health centers and will provide a list of women around menopausal age along with their phone number, then will call them and they will be invited to participate in the study. In face to face session, eligibility criteria will be assessed and the Green Scale, the Spielberger State-Trait Anxiety Inventory and Female Sexual Function Index will be completed through interview with eligible participants. Participants will be randomly assigned into three groups (two intervention groups and one control group) through block randomization.
Participants/Inclusion and exclusion criteria
Participants will be menopausal women with hot flush at least twice a week.
Intervention groups
The first intervention group will receive oral curcumin capsule, the second intervention group will receive the oral vitamin E capsule and the control group will receive the placebo.
Main outcome variables
The main outcome variables include hot flash and anxiety, which will be assessed by the Green scale and the Spielberger State-Trait Anxiety Inventory, respectively.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120718010324N44
Registration date: 2018-06-23, 1397/04/02
Registration timing: prospective

Last update: 2018-06-23, 1397/04/02
Update count: 0
Registration date
2018-06-23, 1397/04/02
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-04, 1397/04/13
Expected recruitment end date
2018-10-05, 1397/07/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral capsule of curcumin and vitamin E on the hot flush and anxiety in postmenopausal women: a triple blind randomised controlled trial
Public title
The effect of curcumin and vitamin E on hot flush and anxiety in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Having sufficient literacy to complete the questionnaire or the presence of a literate person in the family Normal menopause Being married Women who have been under 6 years old since their menopause. Having at least 40 years and a maximum of 60 Having hot flush at least twice a week
Exclusion criteria:
Use of tobacco and alcoholic beverages and herbal medicines Stressful factors such as the death of relatives in the first six months of the past and loss of occupation Known psychiatric or systemic problems including cardiovascular, digestive, liver, endocrine, etc. Use of any effective medicines for hot flashes (Clonidine, Methyl dopa, Gabapentin, Selective Serotonin Reuptake Inhibitors (SSRIs), Norepinephrine inhibitors (SNRI), and Soy isoflavone Factors that cause vasomotor disorder, such as thyroid disease, according to the person expression Use of any effective medication to treat a person's sexual response (Antihypertensive, Thiazide diuretics, Antidepressant drugs such as Serotonin and Noradrenaline and Reuptake, Antihistamines, Barbiturates, Narcotics, Diazepam, Amphetamines, Cocaine History of allergy to turmeric or other drugs, food and color Taking anticoagulant drugs (Hyarin, Warfarin, Enoxaparin)
Age
From 40 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned by block randomization method with a 1: 1: 1 assignment ratio to three groups (two intervention groups and one control group).
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, researcher and analyst will be completely blind in this study. The drug and the placebo will be the same in appearance (shape, color and odor), and the packaging of drugs will be done by someone who is not involved in the research
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2018-05-27, 1397/03/06
Ethics committee reference number
IR.TBZMED.REC.1397.208

Health conditions studied

1

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

2

Description of health condition studied
anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
hot flush
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
Hot flush checklist

2

Description
Anxiety
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
State- Trait Anxiety Inventory

Secondary outcomes

1

Description
Sexual function
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
FSFI= Female Sexual Function Inventory

Intervention groups

1

Description
The first Intervention group will receive oral capsules of curcumin twice a day at a dose of 500 milligrams for eight weeks
Category
Treatment - Drugs

2

Description
The second intervention group will receive oral Capsule Vitamin E 200 IU twice a day for eight weeks.
Category
Treatment - Drugs

3

Description
The control group will receive placebo capsules twice a day for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Centers in Ahar city
Full name of responsible person
Khatereh Ataei
Street address
Ahar city, East Azarbaijan county, Iran
City
Ahar
Province
East Azarbaijan
Postal code
5143814998
Phone
+98 41 4438 8341
Email
iro@tbzmed.ac.ir
Web page address
http://tabriz-phc.tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 1334 4280
Email
iro@tbzmed.ac.ir
Web page address
http://researchvice.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khatereh Ataei
Position
MSc Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5155884818
Phone
+98 41 4438 8341
Email
khaterehatayi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghorvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
aculty of Nursing Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
mirghafourvandm@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirgharvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
mirghafourvandm@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of the clinical study will be published as a paper.
When the data will become available and for how long
Immediately after publishing the results.
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article.
From where data/document is obtainable
mirghafourvandm@tbzmed.ac.ir
What processes are involved for a request to access data/document
Maximum one week after the communication by email.
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