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IRCT20180707040370N11 IRCT 2024-08-16 Hamedan University of Medical Sciences The effect of probiotic consumption on fatigue and sexual function in postmenopausal women The effect of probiotic consumption on fatigue and sexual function in postmenopausal women 2024-09-05 anticipated 80 Complete https://irct.ir/trial/77152 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 40 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 the analyzer knows the contents of the package and double triple blinding will be performed. 2 fatigue severity and sexual function in postmenopausal women. 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 casei, Lactobacillus acidophilus, Lactobacillus rhamnusos,Bifidobacterium Lactis, Bifidobacterium longum, Bifidobacterium breve and with dose CFU 3×109.This drug Will be Producted by Company of Zist Takhmir. Intervention 2: Control group: 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 38381938 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 1938 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 1938 en.jenabi@yahoo.cim Hamedan University of Medical Sciences 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 45 years 55 years Female N95.1 Menopausal and female climacteric states Treatment - Drugs Placebo Intervention group: Probiotic supplement will be prescribed in the form of Oral Capsule 200 mg, Once a day for 6 weeks. Including Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnusos,Bifidobacterium Lactis, Bifidobacterium longum, Bifidobacterium breve and with dose CFU 3×109.This drug Will be Producted by Company of Zist Takhmir. Control group: 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. Fatigue severity. Timepoint: Before the intervention, 3 and 6 weeks after the intervention. Method of measurement: Fatigue Severity Scale (ّFFS). Sexual function. Timepoint: Before the intervention, 3 and 6 weeks after the intervention. Method of measurement: Female Sexual Function Index. Menopausal quality of life. Timepoint: Before the intervention, 3 and 6 weeks after the intervention. Method of measurement: Menopause-Specific Quality of Life (MENQOL). Hamedan University of Medical Sciences Approved 2024-08-03 کمیته اخلاق دانشگاه علوم پزشکی همدان Hamadan University of Medical Sciences, Fahmiheh Street, Hamadan همدان Hamadan Iran (Islamic Republic of)