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IRCT20220516054881N1 IRCT 2022-05-25 Kashan University of Medical Sciences Comparison of the effect of vitamins D and E with conjugated estrogen vaginal cream on menopausal vulvovaginal symptoms Comparison of the effect of vitamins D and E with conjugated estrogen vaginal cream on menopausal vulvovaginal symptoms 2022-05-30 anticipated 66 Complete https://irct.ir/trial/63663 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method will be: first, the group receiving vitamin D with the letter A, the group receiving vitamin E with the letter B and the group receiving conjugated estrogen with the letter C, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists The randomization list will be prepared by selecting a sample size of 66 (3 groups of 22) and a balanced 6-part blocking method. Then, through the obtained randomization list, the enrolled people (in the order of enrollment time) will be assigned to one of the two groups A or B or C, Blinding description: All three groups receive the same drugs in the same package, size and box. The codes remain with one of the research project colleagues and will be decoded at the end of the study. None of the administrators and patients have any information about the type of codes of each patient after analyzing the data. Thus, this study is performed in two blinds. 3 Volvaginal symptoms of menopause. Intervention 1: Intervention group: Receiving pearl vitamin D with a dose of 50000 IU (Cholecalciferol) under the brand name D-vigel from Dana Pharma once a week for 8 weeks. Intervention 2: Intervention group: Receiving vitamin E capsule (d alpha tocopheryl acetate) with IU400 dose under the brand name of Hakim Vitamin E from Hakim Pharmaceutical Company daily for 8 weeks. Intervention 3: Control group: Apply conjugated estrogen vaginal cream 0.625 mg with the brand name Stromarin from Abu Reihan Pharmaceutical Company for one day daily for 14 days and then twice a week, deep inside the vagina before going to bed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Its release schedule is not yet known
public Sayad Nazari
Qutb Ravandi Boulevard, Kashan Medical Sciences Residential Complex
Kashan Iran (Islamic Republic of) 8715985131 +98 31 5510 3400 nazari-s@kaums.ac.ir Kashan University of Medical Sciences scientific Zohreh Tabasi
Qutb Ravandi Boulevard, Shahid Beheshti Hospital
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5500 9999 drtabasiz@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) The patient is menopausal Pap smears have been normal for the last 3 years She has symptoms of vaginal atrophy Vaginal maturity index should be less than or equal to 55 Vitamin D levels should be less than or equal to 30 The minimum entry age is 45 years and the maximum age is 65 years 45 years 65 years Female She has a vaginal infection She has genital abnormalities She has a history of taking sex hormones during the 8 weeks before the study She may have vaginal bleeding of unknown cause She has a history of consuming a lot of phytoestrogens such as soy, red clover, fenugreek and Vitex in the past month N95.2 Postmenopausal atrophic vaginitis Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Receiving pearl vitamin D with a dose of 50000 IU (Cholecalciferol) under the brand name D-vigel from Dana Pharma once a week for 8 weeks Intervention group: Receiving vitamin E capsule (d alpha tocopheryl acetate) with IU400 dose under the brand name of Hakim Vitamin E from Hakim Pharmaceutical Company daily for 8 weeks Control group: Apply conjugated estrogen vaginal cream 0.625 mg with the brand name Stromarin from Abu Reihan Pharmaceutical Company for one day daily for 14 days and then twice a week, deep inside the vagina before going to bed. Vaginal cell maturation index. Timepoint: At the beginning of the study, 8 weeks after taking the drug. Method of measurement: Vaginal cytology. Vitamin D levels. Timepoint: The beginning of the study. Method of measurement: Blood test. Vaginal dryness. Timepoint: The beginning of the study, day 28 and day 56. Method of measurement: Questionnaire and Likert scale. Vaginal burning. Timepoint: The beginning of the study, day 28 and day 56. Method of measurement: Questionnaire and Likert scale. Vaginal itching. Timepoint: The beginning of the study, day 28 and day 56. Method of measurement: Questionnaire and Likert scale. Disparony. Timepoint: The beginning of the study, day 28 and day 56. Method of measurement: Questionnaire and Likert scale. Abnormal vaginal discharge. Timepoint: The beginning of the study, day 28 and day 56. Method of measurement: Questionnaire and Likert scale. Kashan University of Medical Sciences Approved 2022-04-16 Ethics Committee in Research, School of Medicine and Dentistry, Kashan University of Medical Science Qutb Ravandi Boulevard - Kashan University of Medical Sciences Kashan Isfehan Iran (Islamic Republic of)