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Effects of herbal product of chicory and fumitory on hot flashes in postmenopausal women

Protocol summary

Study aim
Effects of herbal product of chicory and fumitory on hot flashes in postmenopausal women
Design
Before and after pilot clinical trial, Phase 3, on 45 patients, without blinding and control group
Settings and conduct
After recording the information of patients admitting to Shohadaye Tajrish Hospital, they complete the form of the number and severity of hot flashes episodes on a daily basis for a week, and at the end of the week, the number and severity of hot flashes episodes as well as the number of days without hot flashes episodes are calculated and considered as baseline values ​​before the intervention. Then, patients use 5 cc of chicory and fumitory herbal products daily, fasting in the morning and at night for 4 weeks, and also complete the the form. After 4 weeks, the effect of the herbal product on the number and severity of hot flashes is analyzed.
Participants/Inclusion and exclusion criteria
Menopause (absence of menstruation during the last 12 months); Complaints of hot flashes; No use of anticoagulant medications; No history of any cardiovascular disease, diabetes, hypertension, neurological disease or cancer; Do not use cupping, acupuncture, medication, especially hormonal drugs, and not treating hot flashes with other methods during the last month; Do not use antidepressants in the last 4 weeks (venlafaxine, bupropion, fluoxetine, paroxetine, citalopram, sertraline); FSH > 40 IU/L; Having the consent to start and continue the study
Intervention groups
A group of chicory and fumitory product consumer
Main outcome variables
Improvement of hot flashes severity in postmenopausal women

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160722029027N13
Registration date: 2022-07-05, 1401/04/14
Registration timing: retrospective

Last update: 2022-07-05, 1401/04/14
Update count: 0
Registration date
2022-07-05, 1401/04/14
Registrant information
Name
Leila Nazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
nazari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of herbal product of chicory and fumitory on hot flashes in postmenopausal women
Public title
Effects of herbal product of chicory and fumitory on hot flashes in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Menopause (absence of menstruation during the last 12 months) Complaints of hot flashes FSH > 40 IU/L Having the consent to start and continue the study
Exclusion criteria:
History of any cardiovascular disease, diabetes, hypertension, neurological disease, cancer of the breast, ovary, uterus, or hormone-sensitive diseases such as endometriosis or uterine fibroids Use antidepressants in the last 4 weeks (venlafaxine, bupropion, fluoxetine, paroxetine, citalopram, sertraline) Use of anti-anxiety drugs, gabapentin, pregabalin, clonidine, aspirin, vitamin E, omega 3, phytoestrogen supplements and high phytoestrogen diet during the intervention Use of acupuncture and complementary medicine (hypnosis, psychosomatic therapies) during the intervention Use cupping, acupuncture, medication, especially hormonal drugs, and not treating hot flashes with other methods during the last month Use of anticoagulant medications Taking herbal medicine or special diet to treat hot flashes Drug allergy to chicory and fumitory products
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 45
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
School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Yaman St, Chamran highway, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2019-07-30, 1398/05/08
Ethics committee reference number
IR.SBMU.MSP.REC.1398.460

Health conditions studied

1

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

Primary outcomes

1

Description
Number and severity of hot flashes episode
Timepoint
Daily
Method of measurement
Recording the number and severity of hot flashes episodes (Green Climactric Scale) by patient

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Use of 5 cc of chicory and fumitory products, in the morning and at night, for 4 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Tajrish hospital
Full name of responsible person
Dr. Leila Nazari
Street address
Tajrish square
City
Teharn
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
nazari@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Yaman st, Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 31 5533 4611
Email
nazari@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Nazari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Velenjak, Yaman st, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2271 8000
Fax
+98 21 2274 1171
Email
nazari@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Nazari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani hospital, Yaman st, Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 2558
Fax
Email
nazari@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Nazari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani hospital, Yaman st, Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 2558
Fax
Email
nazari@sbmu.ac.ir
Web page address

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
General patient data
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
Undecided - It is not yet known if there will be 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
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