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General information
2018-07-27, 1397/05/05
2018-08-23, 1397/06/01
2018-0708-2723 00:00:00
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Changed sampling date that was incorrectly recorded
Changed sampling date that was incorrectly recorded
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تغییر تاریخ نمونه گیری تحقق یافته که به اشتباه ثبت شده بود
تغییر تاریخ نمونه گیری تحقق یافته که به اشتباه ثبت شده بود
Protocol summary
Study aim
Determining the effect of violet syrup on hot flashes and sleep quality in postmenopausal women.
Design
Clinical trial with control group, with parallel groups, triple blind, randomized
Settings and conduct
Mashhad Health Centers
Participants/Inclusion and exclusion criteria
At least the reading and writing skills; postmenopausal patient; experience at least 3 hot flashes throughout the day; having a sleep quality score higher than 5; age 40 to 65 years old; no smoking and alcohol; lack of hormone therapy in the last 6 months; not having depression, stress, or severe anxiety; not having physical illness; lack of mental illness; non-infectious and febrile illness; lack of simultaneous use of hypnotic and herbal medicines affecting sleep and hot flashes; do not take medications that improve vasomotor symptoms; non-use of anti-coagulants, anxiolytic and non-steroidal drugs; not having a night shift; non-use of isoflavone absorption reducing agents during the study, such as antibiotics for 6 weeks, and proton pump inhibitor anti-acids.
Intervention groups
In the intervention group, vials of violet syrup were used and in the control group, placebo was used.
Main outcome variables
Flushing and sleep quality
General information
Reason for update
Changed sampling date that was incorrectly recorded
Acronym
IRCT registration information
IRCT registration number:IRCT20180514039660N1
Registration date:2018-08-07, 1397/05/16
Registration timing:prospective
Last update:2022-04-20, 1401/01/31
Update count:2
Registration date
2018-08-07, 1397/05/16
Registrant information
Name
Fatemeh Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 2696
Email address
lotfif951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
2018-08-23, 1397/06/01
Actual recruitment end date
2019-04-30, 1398/02/10
Trial completion date
2019-04-30, 1398/02/10
Scientific title
The effect of viola odorata syrup on hot flashes and sleep quality in postmenopausal women
Public title
The effect of viola odorata syrup on hot flashes and sleep quality in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least the reading and writing skills
Post-menopausal (at least 12 months of self-deprivation of menstruation, without contact with pregnancy and lactation, or other medical and pharmaceutical reasons or serum FSH> 40 IU / L).
Experience at least 3 hot flashes throughout the day
Having a sleep quality score higher than 5
Age 40 to 65 years old
Exclusion criteria:
Tobacco and alcohol consumption
Hormone therapy in the last 6 months
Having depression, stress or severe anxiety (score less than 19 below the stress scale, score less than 10 below the anxiety scale or score less than 14 below the depression scale of the DASS-21 questionnaire)
Having physical illnesses (such as diabetes, hypertension, pulmonary, heart, infectious diseases, cancers)
Mental illness
Infectious and febrile illnesses (such as respiratory, urinary and hepatitis infections, thyroid disease, and those with hot flush as one of their symptoms).
Concomitant use of hypnotic and herbal medicines affecting sleep and hot flashes (such as soy and herbs)
Taking medications that improve vasomotor symptoms (such as clonidine, antidepressants, tamoxifen, raloxifene, anticonvulsants like gabapentin)
Use of anti-coagulants, anti-anxiety and non-steroidal drugs
Having a night shift
The use of isoflavone absorption inhibitors during the study, such as antibiotics for 6 weeks, and proton pump inhibitors (omeprazole, lansoprazole, ropiperazole, pantoprazole, osomoperazole)
Age
From 40 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
94
Actual sample size reached:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Firstly, from the 5th and Samen areas of the city of Mashhad, the names of all these centers are written on paper and selected through the drawings of two centers, then from the sub-set of the two centers, each of which has two centers suitable for personnel cooperation and the presence of The menopause women will be selected and the researcher will be present at each of these centers and selected on the basis of the checklist for the selection of the research unit, eligible women to enter the study are available. Then the violet flower syrup from Barij and Placebo, the researcher will be provided by the pharmacist's consultant in similar glasses. Each glass has a code chosen by the random number table, and only the pharmacist's consultant knows. Individuals with entry requirements are assigned code numbers in groups respectively.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blind the violet flower syrup from Barij and Placebo, the researcher will be provided by the pharmacist's consultant in similar glasses. Each glass has a code chosen by the random number table, and only the pharmacist's consultant knows. Individuals with entry requirements are assigned code numbers in groups respectively. Therefore, until the end of the study, the research units, researcher and statistician will not be aware of the codes related to violet syrup and placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery, Mashhad University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Doctora Crossroads, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.005
Health conditions studied
1
Description of health condition studied
Hot flashes
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
2
Description of health condition studied
sleep disorders
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
Hot flashes
Timepoint
From a week before the study begins to immediately after the intervention
Method of measurement
Hot flashes daily registration form
2
Description
Sleep quality
Timepoint
Before starting the study until immediately after the intervention
Method of measurement
Pittsburg Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Violet Flower Syrup from Barís Essence, every 5 ml of flavonoid containing syrup is 16.25-9 mg. The units are taking 5 ml every other day forone month each two times a day.
Category
Treatment - Other
2
Description
Control group: Use of placebo in similar glasses of syrup; the units are taking 5 ml every other day forone month each two times a day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Samen Health Center
Full name of responsible person
Dr. Mohammad Mehdi Izadpanah
Street address
Akhund Khorasani 24, Gonbad Sabz Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9135963114
Phone
+98 51 3852 6761
Email
lotfif951@mums.ac.ir
2
Recruitment center
Name of recruitment center
Health center of Hazrat Zahra S.
Full name of responsible person
Brattali Arab Nejad
Street address
Hasheminejad 14, Hasheminejad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9185837715
Phone
+98 51 3222 9289
Email
lotfif951@mums.ac.ir
3
Recruitment center
Name of recruitment center
Shahid Ghodsi Health Center
Full name of responsible person
Brattali Arab Nejad
Street address
Next to the blood bank, The end of Sanabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9185837715
Phone
+98 51 3845 1552
Email
lotfif951@mums.ac.ir
4
Recruitment center
Name of recruitment center
Silo Health Center
Full name of responsible person
Brattali Arab Nejad
Street address
16th Resalat, Resalat Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9185837715
Phone
+98 51 3274 5585
Email
lotfif951@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Darabi Mahboob
Street address
Faculty of Nursing and Midwifery, Doctora Crossroads, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
lotfif951@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Lotfi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Doctora Crossroads, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
lotfif951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Zahra Karimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Doctora Crossroads, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Karimifz@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Lotfi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Doctora Crossroads, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
lotfif951@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available