Double-blind clinical trial in postmenopausal women aged 40 to 60 with hot flushes. Patients are randomly selected on the basis of quadruple blocks for the use of one form of drug. Total volume: 80 in intervention and control groups
Settings and conduct
Participants are selected from 40 to 60 years old postmenopausal women with hot flashes referred to the Iranian Healthcare Center of Babol University of Medical Sciences. After completing the demographic data and personal consent, the GREEN and HFRDIS questionnaires were completed to determine the severity of the symptoms of the patients at the start, the 4th and 8th weeks during the treatment, and the 4th week after the completion of the treatment, and a questionnaire on the frequency of symptoms at the time of treatment was provided to patients delivered at the end of 8 weeks of treatment
Participants/Inclusion and exclusion criteria
Inclusion criteria
1: Patients aged 40 to 60 years.
2: Those who have had 3 times daily intake from the previous month.
3: People at least 12 and up to 60 months past the last month.
4: FSH> 40
Exit criteria:
1: People with underlying illness (liver, kidney, coagulation and metabolic disorders, such as thyroid problems).
2: People with a history of allergy to herbal medicines.
3: People who have a history of using anti-anxiety drugs,estrogen and progesterone hormones in the last 6 months, and other medicines that may affect hot flashes.
4: People with a history of asthma and allergies.
5. Pap smear and uterine ultrasonography are reported to be pathologic.
6. Mass or malignancy in the breast, ovary
Intervention groups
Patients were randomly divided into two groups the control group (Placebo capsule, 250 mg, twice daily) and the treatment group ("Silybum marianum" capsule, 250 mg, twice daily).
Main outcome variables
Severity and frequency of hot flashes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190223042811N1
Registration date:2019-06-03, 1398/03/13
Registration timing:registered_while_recruiting
Last update:2019-06-03, 1398/03/13
Update count:0
Registration date
2019-06-03, 1398/03/13
Registrant information
Name
zohreh saberi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7795 0522
Email address
z.saberi@mubabul.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2020-01-05, 1398/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of a preparation from of Silybum marianum on hot flashes in postmenopausal women
Public title
Effect of Silybum marianum extract on hot flash symptoms in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 40 to 60 years old. 3 times daily from a previous month.
Individuals who have been treated at least
People who are at least 12 and at most 60 months have passed since the last month. (Menopause)
FSH>40
Exclusion criteria:
Use smoking, Valkel cigarettes.
People with underlying diseases (liver, kidney, metabolic disorders such as thyroid problems) are.
They have a history of sensitivity to herbal medicines.
People who have a history of using anxiolytics, antidepressant, estrogen and progesterone hormones in the last 6 months, use anticoagulant and anti-inflammatory drugs like ibuprofen and other drugs affecting hot flashes.
People who have a history of asthma and allergies.
Pathologic and ultrasonography have been reported in the uterus.
Have a history of mass or malignancy in the breast, ovary or uterus.
Do not have natural blood pressure.
Have a history of thromboembolism.
Age
From 40 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization in this study is quadruple blocking method and the randomization unit is individual and tool is statistical software. The sequencing will be done by quadruple blocking. Concealing done by using similar capsule box form for both groups, and the data analyzer knows how to allocate the intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and the intervening person are completely unaware of which drug they received and delivered.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Research Ethics Committee, Health Research Institute, Babol University of Medical Scie
Street address
University of Medical Sciences, Babol University of Medical Sciences, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4615973899
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.231
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
Primary outcomes
1
Description
Hot flashes
Timepoint
At the beginning of treatment, weeks 4 and 8 during treatment and 4 weeks after treatment
Method of measurement
The standard GREEN questionnaire, HFRDIS
2
Description
The frequency of hot flashes
Timepoint
At the beginning of treatment, weeks 4 and 8 during treatment and 4 weeks after treatment
Method of measurement
Daily Inventory of Hot flashes
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: capsules containing 250 mg of fruit extract "silybum marianum" twice a day for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: capsules containing 250 mg of starch powder twice a day for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Persian Medicine clinic, Babol university of medical sciences
Full name of responsible person
Zohreh Saberi
Street address
Babol, Ganjafrooz Street , Persian Medicine clinic
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3225 3526
Email
zohrehsaberi90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol University of Medical Sciences, Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Zohreh Saberi
Position
Ph.D. student of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Babol University of Medical Sciences, Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
7615973899
Phone
+98 11 3219 4728
Email
Zohrehsaberi90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Narjes Gorji
Position
Assistant Professor, Babol University of medical sciences
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Babol University of Medical Sciences, Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4728
Email
nargess_gorji@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zohreh Saberi
Position
Ph.D. Student of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Babol University of Medical Sciences, Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3225 3526
Email
ZOHREHSABERI90@GMAIL.COM
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
Undecided - It is not yet known if there will be a plan to make this available
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