]>
IRCT20240214061006N1 IRCT 2024-02-29 Shahid Beheshti University of Medical Sciences A study on the effect of vaginal aloe vera cream on the sexual function and sexual satisfaction of Post- menopausal women A study on the effect of vaginal aloe vera cream on the sexual function and sexual satisfaction of Post- menopausal women 2024-04-02 anticipated 100 Complete https://irct.ir/trial/75570 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Other design features: Research units will be divided into intervention and control groups. The intervention group will use aloe vera vaginal cream and the control group will use placebo for 2 months, Randomization description: The research units will be divided into two intervention and control groups in a simple random manner using Excel software and random number function. The list of people will be determined before the start of the study and people will be placed in each of the groups in order of entry. In this way, the researcher will be unaware of the type of group of each person before starting the intervention, Blinding description: In this research, the researcher, the participants and the data analyst will not know which group (intervention or control) each participant is in (at the beginning of the research, the participant will be informed that he may be in any of the intervention or control groups). be controlled), so that with simple random method and random number function, it will be determined that according to the participant number (which will be assigned according to the order of entry into the research) that participant will be placed in which group A or B, but Until the end of the research, it will not be clear which group A or B is intervention or control. 3 Condition 1: sexual function. Condition 2: sexual satisfaction. Intervention 1: Intervention group: In this research, aloe vera plant will be prepared from the greenhouse around Tehran and after confirming the scientific name, at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences and Health Services, its leaves will be separated and extracted with ethanol. It is inserted into the base of the vaginal cream and it will be prepared in the form of aloe vera vaginal cream, and it will be autoclaved after preparation. which will be consumed vaginally by the research samples for 2 weeks, every night and then for the next 6 weeks, three nights a week and during sexual intercourse, 7 grams each time with an applicator. Intervention 2: Control group: In this research, the vaginal cream placebo will be based on vaginal cream without any effective ingredients (including cetostearyl alcohol, petroleum gel, glycerin, water, mineral oil, protective and antioxidant substances, etc.) Shahid Beheshti's health care services have been prepared and after preparation, it will be autoclaved, which in terms of shape, smell, color, size and amount is completely similar to vaginal aloe vera cream, which is applied every night for 2 weeks and then three nights a week for the next 6 weeks. And during sexual intercourse, 7 grams will be taken vaginally with an applicator. 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 There is no further information.
public Neda Khalaji
Gohardasht, moazen blvd, north pirozi ave, bostan19, number15
Karaj Iran (Islamic Republic of) 3147834579 +98 26 3431 8371 khalajineda3@gmail.com Shahid Beheshti University of Medical Sciences scientific dr.Masoumeh simbar
Vali Asr St., intersection of Ayat A... Hashemi Rafsanjani Highway, in front of Shahid Rajaee Heart Hospital, Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5376 msimar@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 45-65 years Experience of at least 12 months of amenorrhea Natural menopause (absence of menopause following surgery, absence of premature menopause (at the age of less than 40)) Postmenopausal women who are in their first 10 years of menopause. Having a husband and having sex with her Lack of sexual impotence in the husband (according to the woman) Having symptoms of vaginal dryness, dyspareunia and itching Not taking herbal hormonal drugs containing phytoestrogens or hormonal supplements in any form Being literate in reading and writing Not using herbal or chemical drugs affecting sexual function No history of hysterectomy and mastectomy A maximum of five natural births Not having genital infections (according to the woman) BMI less than 30 No stressful event has occurred in the last 6 months (death or illness of close relatives, major change in living situation) in any of the couples. According to the wife, there are no mental problems (illness under observation or treatment by a doctor) in any of the couples. Absence of disease affecting sexual function 45 years 65 years Female Treatment - Drugs Treatment - Drugs Intervention group: In this research, aloe vera plant will be prepared from the greenhouse around Tehran and after confirming the scientific name, at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences and Health Services, its leaves will be separated and extracted with ethanol. It is inserted into the base of the vaginal cream and it will be prepared in the form of aloe vera vaginal cream, and it will be autoclaved after preparation. which will be consumed vaginally by the research samples for 2 weeks, every night and then for the next 6 weeks, three nights a week and during sexual intercourse, 7 grams each time with an applicator. Control group: In this research, the vaginal cream placebo will be based on vaginal cream without any effective ingredients (including cetostearyl alcohol, petroleum gel, glycerin, water, mineral oil, protective and antioxidant substances, etc.) Shahid Beheshti's health care services have been prepared and after preparation, it will be autoclaved, which in terms of shape, smell, color, size and amount is completely similar to vaginal aloe vera cream, which is applied every night for 2 weeks and then three nights a week for the next 6 weeks. And during sexual intercourse, 7 grams will be taken vaginally with an applicator. Sexual function score in females sexual function index questionnaire. Timepoint: At the beginning of the study and 4 and 8 weeks after starting to use vaginal aloe vera cream. Method of measurement: females sexual function index questionnaire. Sexual satisfaction score in Hudson's sexual satisfaction questionnaire. Timepoint: At the beginning of the study and 4 and 8 weeks after starting to use vaginal aloe vera cream. Method of measurement: Hudson's sexual satisfaction questionnaire. Shahid Beheshti University of Medical Sciences Approved 2024-02-11 research ethics committess of school of pharmacy and nursing and midwifery--shahid beheshti universi Tehran, Vali Asr St., intersection of Ayat A... Hashemi Rafsanjani Highway, in front of Shahid Rajaee Heart Hospital, Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)