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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
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
1
-
Sponsor
-
-
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
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