Protocol summary
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Study aim
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The effect of probiotic administration on severity of the menopausal symptoms and mental health of the menopausal women
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Design
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Clinical trial with control group, with parallel groups, triple blind, randomized
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Settings and conduct
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Participants are randomly assigned to the two groups of 45 recipients of Probiotic capsule and placebo group.This study will be conducted in Comprehensive Health Centers of Hamadan city. In this study, neither the researcher, nor the menopausal women and nor the analyzer knows the contents of the package and triple blinded will be performed. In intervention group, Probiotic capsule and in Control group, placebo will be prescribed Once a day for 6 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age between 45-55, having menopause symptoms; not using cigarette or alcohol, not having physical or mental diseases, not using of relaxation techniques, not using of hormonal or herbal therapies
Exclusion criteria: irregular use of the drug, refuse from continuing to participate in study
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Intervention groups
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Intervention group: Probiotic supplement will be prescribed in the form of Oral Capsule 200 mg, Once a day for 6 weeks. This drug Will be Producted by Hamadan University of Medical Sciences.
Control group: placebo will be prescribed in the form of Oral Capsule contain ُof Starch 200 mg Once a day for 6 weeks. The placebo is made in Hamadan University of Medical Sciences
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Main outcome variables
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Severity of menopause symptoms
Stress-anxiety-depression
General information
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Reason for update
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Having menopause symptoms
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180707040370N9
Registration date:
2023-01-19, 1401/10/29
Registration timing:
prospective
Last update:
2024-08-16, 1403/05/26
Update count:
2
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Registration date
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2023-01-19, 1401/10/29
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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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2023-02-20, 1401/12/01
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Expected recruitment end date
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2023-08-23, 1402/06/01
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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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The effect of probiotic administration on severity of the menopausal symptoms and mental health of the menopausal women
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Public title
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The effect of probiotic administration on severity of the menopausal symptoms and mental health
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
age between 45-55
not using cigarette or alcohol
not having physical or mental diseases
not using of relaxation techniques
not using of hormonal or herbal therapies
at least 1 to 5 years have passed since menopause
Having menopause symptoms
Exclusion criteria:
irregular use of the drug
refuse from continuing to participate in study
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Age
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From 45 years old to 55 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants are randomly selected by random.org computer program that are assigned to the two groups of 45 recipients of capsule Probiotic and placebo.
The allocation of the participants to the groups is performed by method of allocation concealment. In this way, using the random block 4, the allocation sequence is specified. Then, in the sealed envelopes, the intervention name is written in sequential order, and is numbered accordingly
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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The drug packages are similar and were given to menopausal women by other person. This person does not inform about the package contents.
Therefore, neither the researcher, nor the menopausal women and nor the analyzer knows the contents of the package and triple blinding will be performed.
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Placebo
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Used
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Assignment
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Parallel
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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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2023-01-18, 1401/10/28
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Ethics committee reference number
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IR.UMSHA.REC.1401.887
Health conditions studied
1
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Description of health condition studied
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Severity of the Menopausal Symptoms and Mental health
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ICD-10 code
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N95.1
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ICD-10 code description
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Menopausal and female climacteric states
Primary outcomes
1
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Description
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Severity of menopause symptoms
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Timepoint
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Before the intervention, 3 and 6 weeks after the intervention
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Method of measurement
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MRS scale
2
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Description
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Stress
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Timepoint
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Before the intervention, 3 and 6 weeks after the intervention
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Method of measurement
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Questionnaire DASS-21
3
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Description
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anxiety
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Timepoint
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Before the intervention, 3 and 6 weeks after the intervention
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Method of measurement
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Questionnaire DASS-21
4
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Description
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depression
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Timepoint
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Before the intervention, 3 and 6 weeks after the intervention
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Method of measurement
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Questionnaire DASS-21
Intervention groups
1
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Description
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Intervention group: Probiotic supplement will be prescribed in the form of Oral Capsule 200 mg, Once a day for 6 weeks. Including Lactobacillus plantarum, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium infantis, Bifidobacterium longum, Bifidobacterium breve and Streptococcus thermophilus.This drug Will be Producted by Hamadan University of Medical Sciences
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Category
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Treatment - Drugs
2
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Description
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Control group: placebo will be prescribed in the form of Oral Capsule contain ُof Starch 200 mg Once a day for 6 weeks. The placebo is made in Hamadan University of Medical Sciences
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Category
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Treatment - Drugs
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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No
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Title of funding source
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En Hamedan 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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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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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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A portion of the information, such as information on the main outcome or the like, can be shared
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When the data will become available and for how long
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6 months after publishing the results
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To whom data/document is available
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Researchers working in academia
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Under which criteria data/document could be used
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Data analysis is permitted with the author's permission.
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From where data/document is obtainable
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Hamadan ،Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
Responsible person: Ensiyeh Jenabi
Postal code: 6517838695
Phone number: +98 81 3838 0496
Email: en.jenabi@yahoo.com
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What processes are involved for a request to access data/document
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Requests should be submitted to the corresponding author via email. He will follow up with the inquiry
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Comments
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