Effect of Of fennel capsule on the symptoms of menopause and sex hormones in postmenopausal women who referred to clinics of Shiraz University of Medical Sciences
Effect of fennel capsule on the symptoms of menopause and sex hormones in postmenopausal women
Design
Clinical trial with control group, simple sampling and sample size 100, blind, randomized
Settings and conduct
The research population of all postmenopausal women aged 45-60 years old who referred to the clinics of Shiraz University of Medical Sciences were selected and the sampling would be based on the objective based on the criteria of entry and then divided into two groups of intervention and control with a random number table. Took For people with entry criteria and willingness to participate in the research, the demographic questionnaire will be completed, the menopause measurement criteria will be completed and the research samples will be divided into two intervention and control groups of 50 people according to the random numbers table. The intervention group uses fennel capsules and control groups of placebo capsules. All capsules will be placed in the same packages with codes A and B. The contents of capsules A and B will be retained for samples and unidentified clinical caregivers. Therefore, the present study is two-blind
Participants/Inclusion and exclusion criteria
Entry requirements:
1-Failure to receive HRT
2- Not getting breast cancer treatment (hormone therapy)
3-Lack of surgery in ovarian tumors
Non-arrival conditions:
1- Sudden increase or decrease of weight in the sample
2- Any reason that increases or decreases the level of estrogen in the body
3- For any reason, a person has to have hormone therapy
4- Any sign indicating that allergy to fennel has manifested itself
5- Examples that can cause menstrual disorder for any reason
Intervention groups
The intervention group uses fennel capsules and a control group of placebo capsules
Main outcome variables
Menopause symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160404027207N2
Registration date:2018-04-24, 1397/02/04
Registration timing:registered_while_recruiting
Last update:2018-04-24, 1397/02/04
Update count:1
Registration date
2018-04-24, 1397/02/04
Registrant information
Name
Fatemeh Ghavi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71543404059
Email address
ghavi.fatemeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-03, 1397/01/14
Expected recruitment end date
2018-07-20, 1397/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Of fennel capsule on the symptoms of menopause and sex hormones in postmenopausal women who referred to clinics of Shiraz University of Medical Sciences
Public title
Effect of Of fennel capsule on the symptoms of menopause and sex hormones in postmenopausal women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of surgery in ovarian tumors
Not getting breast cancer treatment (hormone therapy)
Failure to receive HRT
Women aged 45 to 60 years
Exclusion criteria:
Sudden increase or decrease of weight in the sample
Any reason that increases or decreases the level of estrogen in the body
For any reason, a person has to have hormone therapy
Any sign indicating that allergy to fennel has manifested itself
Examples that can cause menstrual disorder for any reason
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was done in a simple method based on purpose based on entry criteria and then divided into two groups: intervention and control using random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The intervention group uses fennel capsules and a control group of placebo capsules. All capsules will be placed in the same packages with codes A and B. The contents of capsules A and B will be retained for samples and unidentified clinical caregivers. Therefore, the present study will be two-blind
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical sciences
Street address
Faculty of Nursing and MidwiferyShiraz., Namazi Sqaure
City
shiraz
Province
Fars
Postal code
71944
Approval date
2017-12-09, 1396/09/18
Ethics committee reference number
IR. SUMS. REC. 1396. 136
Health conditions studied
1
Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Menopause symptoms
Timepoint
Before intervention, two months after the intervention
Method of measurement
Hormones, SF36 General Measurement of Quality of Life, MRS A tool for assessing the severity of postmenopausal women's symptoms
Secondary outcomes
1
Description
Hormonal changes
Timepoint
Before intervention, two months after the intervention
Method of measurement
Elisa Methode
2
Description
Evaluation of the quality of life of postmenopausal women
Timepoint
Before intervention, two months after the intervention
Method of measurement
A general tool for assessing the quality of life SF36
3
Description
Evaluation of severity of symptoms of postmenopausal women
Timepoint
Before intervention, two months after the intervention
Method of measurement
A special tool for assessing the severity of symptoms of postmenopausal women MRS
Intervention groups
1
Description
Intervention group: Oral capsules of 100 mg Fennle for 2 months twice a day
Category
Prevention
2
Description
Control group: Oral capsules of 100 mg placebo for 2 months twice a day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences clinics
Full name of responsible person
Ghavi Fatemeh
Street address
Faculty of Nursing and Midwifery., Namazi Square
City
Shiraz
Province
Fars
Postal code
71944
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
ghavi.fatemeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr janghorban Roxana
Street address
Shiraz University of Medical Sciences, Setad Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
71944
Phone
+98 71 3230 5410
Fax
+98 71 3647 4252
Email
researchnu@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Ghavi Fatemeh
Position
Instructor of Faculty Member of Nursing and Midwifery School
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery., Namazi Square
City
Shiraz
Province
Fars
Postal code
7414846199
Phone
+98 71 3734 0106
Email
ghavi.fatemeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ghavi Fatemeh
Position
Instructor of Faculty Member of Nursing and Midwifery School
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery., Namazi Square
City
Shiraz
Province
Fars
Postal code
7414846199
Phone
+98 71 3734 0106
Email
ghavi.fatemeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ghavi Fatemeh
Position
Instructor of Faculty Member of Nursing and Midwifery School
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery., Namazi Square
City
Shiraz
Province
Fars
Postal code
7414846199
Phone
+98 71 3734 0106
Email
ghavi.fateameh@yahoo.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
Not applicable
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