Protocol summary
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Study aim
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Effect of fennel capsule and evening primrose oil on the symptoms of menopause and sex hormones in postmenopausal women
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Design
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Clinical trial with control group, simple sampling and sample size150, blind, randomized
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Settings and conduct
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The study population is all postmenopausal women aged 45-60 years referred to the clinics of Shiraz University of Medical Sciences and sampling will be done in an easy method based on purpose based on inclusion criteria and then divided into two intervention groups and a control group with a table of random numbers. it is going to happen. For people who have the criteria to enter the research and want to participate in the research, the questionnaire of demographic characteristics, the criterion of menopause will be completed and the research samples will be divided into two groups based on a random number table and a control group of 50 people. In this way, the intervention groups will take placebo capsules containing fennel and evening primrose oil and the control group will take placebo capsules. The contents of capsules A, B and C will be preserved for unknown samples and clinical caregivers, so the present study will be double-blind.
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Participants/Inclusion and exclusion criteria
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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 and evening primrose oil has manifested itself
5- Examples that can cause menstrual disorder for any reason
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Intervention groups
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The intervention groups uses fennel capsules and evening primrose oil and a control group of placebo capsules
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Main outcome variables
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Menopause symptoms
General information
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Reason for update
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At the time of the project, the conditions for using another herbal medicine, namely evening primrose oil, were available, so a trial was conducted in three groups.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160404027207N2
Registration date:
2018-04-24, 1397/02/04
Registration timing:
prospective
Last update:
2022-05-30, 1401/03/09
Update count:
1
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Registration date
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2018-04-24, 1397/02/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-05-02, 1399/02/13
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Expected recruitment end date
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2020-11-18, 1399/08/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Of fennel capsule and evening primrose oil on the symptoms of menopause and sex hormones in postmenopausal women who referred to clinics of Shiraz University of Medical Sciences
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Public title
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Effect of Of fennel capsule and evening primrose oil on the symptoms of menopause and sex hormones in postmenopausal women
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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 and evening primrose oil has manifested itself
Examples that can cause menstrual disorder for any reason
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Age
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From 45 years old to 60 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
150
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Sampling was performed by easy method based on purpose based on inclusion criteria and then divided into two groups of intervention and a control group using a table of random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The intervention groups use capsules containing fennel and evening primrose oil and the control group used placebo capsules. All capsules will be in similar packages with codes A, B and C. The contents of capsules A, B, and C will be preserved for unknown samples and clinical caregivers. Therefore, the present study will be two blinds.
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Placebo
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Used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-12-09, 1396/09/18
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Ethics committee reference number
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IR. SUMS. REC. 1396. 136
Health conditions studied
1
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Description of health condition studied
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Menopausal and female climacteric states
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Menopause symptoms
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Timepoint
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Before intervention, two months after the intervention
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Method of measurement
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Hormones, SF36 General Measurement of Quality of Life, MRS A tool for assessing the severity of postmenopausal women's symptoms
Secondary outcomes
1
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Description
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Hormonal changes
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Timepoint
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Before intervention, two months after the intervention
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Method of measurement
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Elisa Methode
2
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Description
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Evaluation of the quality of life of postmenopausal women
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Timepoint
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Before intervention, two months after the intervention
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Method of measurement
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A general tool for assessing the quality of life SF36
3
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Description
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Evaluation of severity of symptoms of postmenopausal women
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Timepoint
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Before intervention, two months after the intervention
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Method of measurement
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A special tool for assessing the severity of symptoms of postmenopausal women MRS
Intervention groups
1
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Description
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Intervention groups one: The first group of 30 mg capsules of fennel extract for two months and orally twice a day.
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Category
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Prevention
2
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Description
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Intervention group two: 1000 mg capsules of evening primrose oil for two months and orally twice a day.
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Category
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Prevention
3
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Description
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Control group: Oral capsules of 100 mg placebo for 2 months twice a day.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable