Investigating the effectiveness of fenelis syrup on hot flashes in postmenopausal women
Design
Clinical trial on 10 patients (pilot study)
Settings and conduct
Postmenopausal patients referred to Shariat Panahi Health Center, Shahid Beheshti School of Traditional Medicine after initial examinations and physician's opinion and if the patient wishes, were included in the study and treated with fenelis syrup for 1 month (twice a day, morning and night, each time 10 cc), the degree of hot flashes before the treatment, during treatment, and after treatment will be assessed by a questionnaire.
Participants/Inclusion and exclusion criteria
Menopausal women with hot flashes without a history of malignancy and removing the uterus and ovaries
Intervention groups
Postmenopausal women with a history of hot flashes without a history of malignancy and remove the uterus and ovaries referred to Shariat Panahi Health Center who wish to be treated with herbal medicines. Patients will be treated with fenelis syrup for 1 month (twice a day, morning and night, each time 10 cc)
Main outcome variables
"menopausal hot flashes"
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200112046087N4
Registration date:2020-09-28, 1399/07/07
Registration timing:registered_while_recruiting
Last update:2020-09-28, 1399/07/07
Update count:0
Registration date
2020-09-28, 1399/07/07
Registrant information
Name
Hanieh Babaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
haniehbabaei92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pilot study, the effect of fennelis syrup on hot flashes in postmenopausal women
Public title
Evaluation of the effectiveness of fennelis syrup on hot flashes in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Complaining of hot flashes
Menopause
Absence of menstruation during the last 12 months
without removing the uterus and ovaries
Exclusion criteria:
Malignancy
Taking anticoagulants drugs
History of any cardiovascular disease, diabetes, hypertension, neurological disease and cancer
Self-medication for hot flashes such as clonidine, methyl dopa, bellegal
Age
From 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical sciences, Daneshju Blv.
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2020-01-26, 1398/11/06
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.697
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 in postmenopausal women (severity and duration of hot flashes)
Timepoint
Prior to the intervention, during the intervention and 4 weeks after the intervention
Method of measurement
Hot flashes questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: women with hot flashes referred to the clinic. Patients consume 10 cc of syrup made twice a day, morning and night, each time, which has been formulated and quality controlled in the Research Center for Traditional Medicine and Medical Content. (Fenelis syrup contains one to one ratio of fennel seeds and chopped lemongrass leaves)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Faculty of Traditional Medicine (Shariat Panahi Health School)
Full name of responsible person
Mojgan Tansaz
Street address
No. 8, Shams Alley, Vali-e Asr Ave, The Faculty of Traditional Medicine of Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
tansaz_mojgan@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti Faculty of Traditional Medicine
Full name of responsible person
Somayeh Esmaeili
Street address
No. 8, Shams Alley, Vali-e Asr Ave, The Faculty of Traditional Medicine of Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
sesmaeili@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti Faculty of Traditional Medicine
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojgan Tansaz
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley, Vali-e Asr Ave, The Faculty of Traditional Medicine of Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
tansaz_mojgan@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojgan Tansaz
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley, Vali-e Asr Ave, The Faculty of Traditional Medicine of Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
tansaz_mojgan@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojgan Tansaz
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley, Vali-e Asr Ave, The Faculty of Traditional Medicine of Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
tansaz_mojgan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Data will be sent by researchers upon request.
When the data will become available and for how long
After printing the study results
To whom data/document is available
researchers
Under which criteria data/document could be used
For systematic review studies or meta-analysis
From where data/document is obtainable
Dr. Mojgan Tansaz
tansaz_mojgan@yahoo.com
What processes are involved for a request to access data/document