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IRCT20180707040370N9 IRCT 2023-01-19 Hamedan University of Medical Sciences The effect of probiotic administration on severity of the menopausal symptoms and mental health The effect of probiotic administration on severity of the menopausal symptoms and mental health of the menopausal women 2023-02-20 anticipated 90 Complete https://irct.ir/trial/67628 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2 Severity of the Menopausal Symptoms and Mental health. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: A portion of the information, such as information on the main outcome or the like, can be shared When: 6 months after publishing the results To whom: Researchers working in academia Conditions: Data analysis is permitted with the author's permission. Where to obtain: 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 How to obtain: Requests should be submitted to the corresponding author via email. He will follow up with the inquiry Comments:
public Ensiyeh Jenabi
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0496 en.jenabi@yahoo.com Hamedan University of Medical Sciences scientific Ensiyeh Jenabi
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0496 en.jenabi@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 45 years 55 years Female irregular use of the drug refuse from continuing to participate in study N95.1 Menopausal and female climacteric states Treatment - Drugs Treatment - Drugs 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 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 Severity of menopause symptoms. Timepoint: Before the intervention, 3 and 6 weeks after the intervention. Method of measurement: MRS scale. Stress. Timepoint: Before the intervention, 3 and 6 weeks after the intervention. Method of measurement: Questionnaire DASS-21. Anxiety. Timepoint: Before the intervention, 3 and 6 weeks after the intervention. Method of measurement: Questionnaire DASS-21. Depression. Timepoint: Before the intervention, 3 and 6 weeks after the intervention. Method of measurement: Questionnaire DASS-21. En Hamedan University of Medical Sciences Approved 2023-01-18 Ethics Committee of Hamadan University of Medical Sciences Hamadan University of Medical Sciences, Fahmiheh Street, Hamadan Hamadan Hamadan Iran (Islamic Republic of)