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IRCT20220926056043N1 IRCT 2022-09-30 Gonabad University of Medical Sciences The Effect of Cumin Vaginal Cream on Vaginal Atrophy, Sexual Function Index and Sexual Distress in Postmenopausal Women, Gonanbad –2022 The Effect of Cumin Vaginal Cream on Vaginal Atrophy, Sexual Function Index and Sexual Distress in Postmenopausal Women, Gonanbad –2022 2022-11-22 anticipated 84 Complete https://irct.ir/trial/66049 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After sampling by available method, randomization is done by block randomization method. The size of all blocks is equal (8 pieces). And in each block (one in the middle) 4 participants will receive vaginal cream with code A and 4 participants will receive vaginal cream with code B (researcher, participant and analyst are unaware of the contents of the creams), Blinding description: After making the cream and placebo by Mashhad pharmacology specialist, the creams are poured into the tubes coded A and B, and the researcher, participant, analyst will be unaware of the content of the creams. 3 Vaginal atrophy. Intervention 1: Control group: The control group used one-fifth of an applicator (one gram) of vaginal cream every night for six weeks and in the next two weeks every other night. At the end of the 4th and 8th week, follow-up will be done again, including clinical examination and filling in the questionnaires of women's sexual function index, the questionnaire of daily effects of vaginal atrophy and the questionnaire of women's sexual distress. Intervention 2: Intervention group: The intervention group used one-fifth of an applicator (one gram) of vaginal cream every night for six weeks and in the next two weeks every other night. At the end of the 4th and 8th week, follow-up will be done again, including clinical examination and filling in the questionnaires of women's sexual function index, the questionnaire of daily effects of vaginal atrophy and the questionnaire of women's sexual distress. Yes - There is a plan to make this available What will be shared: The participants are coded to increase access to them and their information, and at the time of publication, only the main result is published, and the information of the participants is not published in any way. When: Six months after the results are published To whom: Access is open to the public. Conditions: If a person has a request, without mentioning the coding of the information in a confidential manner, without the personal information of the person, only the main and secondary results will be provided to the requester. Where to obtain: Gmail How to obtain: First, the applicant should send a message to the e-mail and state the reason for using the data. And within a week, the information will be sent to the applicant with conditions and restrictions. Comments:
public Fatemeh kermani
Gonabad University of Medical Sciences, Imam Khomeini Street, Gonabad
Gonabad Iran (Islamic Republic of) 6535149413 +98 51 5722 5027 fatemekermani835@gmail.com Gonabad University of Medical Sciences scientific Narjes bahri
Gonabad University of Medical Sciences, Imam Khomeini Street, Gonabad
Gonabad Iran (Islamic Republic of) 6535149413 +98 51 5722 5027 nargesbahri@yahoo.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Age between 45 and 65 years 1 to 2 years have passed since menopause Having at least a degree with reading and writing literacy Having informed consent to participate in the research Married and monogamous No history of pelvic surgery (according to the participant's statement) Non-use of drugs and alcohol in the woman and her husband (according to the participant's statement) Not taking estrogenic drugs Absence of vaginal bleeding No history of radiation therapy or chemotherapy of the pelvis or the whole body No cancer No history of infertility (according to the participant's statement) Absence of spouse suffering from premature ejaculation or impotence (according to the participant's statement) Absence of vaginal infections (based on the participants' statements and questions about the clinical symptoms of vaginitis) Not suffering from psychological disorders such as: psychosis, schizophrenia, delusions, etc. (according to the participant himself) Having at least 2 symptoms from the descriptive evaluation table of the vaginal mucosa (color, roughness, petechiae, elasticity, dryness) Obtaining a score of 23 or less according to the Sexual Performance Index (FSFI) questionnaire Not having diabetes (according to the participant's statement) 45 years 65 years Female Allergy to cumin vaginal cream Taking any medication affecting sexual performance during the study Starting to take hormonal drugs during the study Experiencing unfortunate or stressful events in a woman or her husband Dissatisfaction to continue cooperation in research Absence of diseases in women or their spouses that affect sexual performance (such as premature ejaculation, cardiovascular, mental, thyroid and cancers) Getting stressed (such as divorce, infidelity of a spouse, death of loved ones in the last year, serious illnesses or imprisonment) N95.2 Postmenopausal atrophic vaginitis Placebo Treatment - Drugs Control group: The control group used one-fifth of an applicator (one gram) of vaginal cream every night for six weeks and in the next two weeks every other night. At the end of the 4th and 8th week, follow-up will be done again, including clinical examination and filling in the questionnaires of women's sexual function index, the questionnaire of daily effects of vaginal atrophy and the questionnaire of women's sexual distress. Intervention group: The intervention group used one-fifth of an applicator (one gram) of vaginal cream every night for six weeks and in the next two weeks every other night. At the end of the 4th and 8th week, follow-up will be done again, including clinical examination and filling in the questionnaires of women's sexual function index, the questionnaire of daily effects of vaginal atrophy and the questionnaire of women's sexual distress. Vaginal atrophy. Timepoint: Before, 4 and 8 weeks after the intervention. Method of measurement: Descriptive assessment of vaginal mucosa. Sexual function. Timepoint: Before, 4 and 8 weeks after the intervention. Method of measurement: Female Sexual Function Index. Women's sexual distress. Timepoint: Before, 4 and 8 weeks after the intervention. Method of measurement: Female Sexual Distress Scal. Vaginal atrophy daily effects. Timepoint: Before, 4 and 8 weeks after the intervention. Method of measurement: Vaginal atrophy daily effects questionnaire. Gonabad University of Medical Sciences Approved 2022-09-26 Ethics Committee of Gonabad University of Medical Sciences Gonabad University of Medical Sciences, Imam Khomeini, Gonabad Gonabad Razavi Khorasan Iran (Islamic Republic of)