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IRCT20181214041963N3 IRCT 2023-03-08 Ahvaz University of Medical Sciences The effect of grape seed extract vaginal cream on the treatment of candidal vaginitis Comparison of the effect of vaginal cream of grape seed extract and clotrimazole on the treatment of candida vaginitis: a randomized clinical trial 2023-04-04 anticipated 70 Complete https://irct.ir/trial/68996 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be done by the available method, in such a way that married and non-pregnant women who refer to the women's clinic of Ahvaz University of Medical Sciences due to candidal vaginitis and are eligible to enter the study are selected. The research units will be assigned to two intervention and control groups using the random block method (six blocks). In this way, the 6 possible states of the blocks (AABB, ABAB, BBAA, BABA, ABBA, BAAB) will be listed first. And each block will be assigned a number from one to six. Then a number between one and six is randomly selected using the random number table, and then people are selected based on the block corresponding to the number. will be assigned to the intervention (A) and control (B) groups. This work will continue until the sample volume is completed, Blinding description: Grape extract cream and Clotrimazole cream will be specified by the pharmacist with a code, and the researcher, research units and statistical analysts do not know the content of the creams according to A and B codes. 3 Candida vaginitis. Intervention 1: Intervention group: grape seed cream, which will be made in Jundishapur Faculty of Pharmacy of Medical Sciences. To prepare medicine, 35 empty metal tubes of 50 grams with 2% grape seed cream will be prepared and filled with 50 grams of tube from Tolo Gostar Bukhara company/along with an applicator/one applicator should be used inside the vagina every night for seven days. Intervention 2: Control group: Clotrimazole vaginal cream 2%, which will be manufactured in Jundishapur Faculty of Pharmacy, along with an applicator, one applicator should be used inside the vagina every night for seven days. Yes - There is a plan to make this available What will be shared: The reviewed data can be shared without mentioning the names of people When: The access period starts 6 months after the results are published To whom: Policymakers, researchers in academic and scientific institutions Conditions: If you have an official letter from the scientific center Where to obtain: Request from the printed magazine and indexed sites, request via e-mail of the project manager How to obtain: 6 months after completing the study of the application, the data will be sent to the project manager, if the conditions are met, up to two months. Comments:
public Atefeh Ebrahimian
Jundishapur Medical Sciences, Golestan St
Ahvaz Iran (Islamic Republic of) 15794 - 61357 +98 61 3311 0000 ebrahimiyan127@gmail.com Ahvaz University of Medical Sciences scientific Naghmeh Yazdi
Jundishapur Medical Sciences, Golestan St
Ahvaz Iran (Islamic Republic of) 15794 - 61357 +98 61 3311 0000 naghmehyazdi@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Consent to participate in research Diagnosis of candidal vaginitis (at least 3 points out of 18 symptom points), Marriage history Not being pregnant Lack of breastfeeding Not suffering from diabetes mellitus and diseases that weaken the immune system Not using broad-spectrum antibiotics in the last 2 weeks Not using vaginal douche in the last 48 hours Not using vaginal drugs during the last week Not using hormonal drugs during the last 3 months Not having audio Not having a candidal infection more than 4 times a year no limit no limit Female Vaginal bleeding Addiction and alcohol consumption Allergy to grapes B37.3 Candidiasis of vulva and vagina Treatment - Drugs Treatment - Drugs Intervention group: grape seed cream, which will be made in Jundishapur Faculty of Pharmacy of Medical Sciences. To prepare medicine, 35 empty metal tubes of 50 grams with 2% grape seed cream will be prepared and filled with 50 grams of tube from Tolo Gostar Bukhara company/along with an applicator/one applicator should be used inside the vagina every night for seven days. Control group: Clotrimazole vaginal cream 2%, which will be manufactured in Jundishapur Faculty of Pharmacy, along with an applicator, one applicator should be used inside the vagina every night for seven days. Improvement of candidiasis signs. Timepoint: 6-8 next days. Method of measurement: Examination and laboratory test and check list. Improvement of disease recurrence. Timepoint: 40 days after the intervention. Method of measurement: Examination and laboratory test and checklist. Jundishapur Medical Sciences Approved 2023-02-22 Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences Golestan St ، Jundi Shapur Ahvaz University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)