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IRCT20221002056076N1 IRCT 2023-08-01 Mashhad University of Medical Sciences Investigating and comparing the effects of jujube vaginal cream and clotrimazole cream on vaginal candidiasis infection Investigating and comparing the effects of jujube vaginal cream and Clotrimazole cream on vaginal Candidiasis in women of reproductive age 2023-08-23 anticipated 74 Complete https://irct.ir/trial/71554 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling is done by the goal-based method and random allocation will be done through blocks of four using the random number table of www.randomization.com site in two groups (intervention and control). The method of concealment will be the allocation of closed envelopes, Blinding description: In order to blind the jujube vaginal cream and Clotrimazole 1% cream in terms of size, color and smell, they are completely similar and the same tubes are provided to the researcher. Hertiop has a code that the pharmacist consultant is aware of. People who are eligible to enter the study are placed in groups according to the codes and using the table of random numbers. Therefore, until the end of the study, the participant and the researcher will not know about the codes related to Anab vaginal cream and Clotrimazole 1% cream. 3 Vaginal candidiasis. Intervention 1: For one week, treated with 3% jujube vaginal cream and 1% clotrimazole, one applicator every night. Intervention 2: Control group: treated with clotrimazole 1% vaginal cream, one applicator every night for one week. 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 Shima Bahadri
School of Nursing and Midwifery, Ibn Sina Street, Doctor's Crossroad, University Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 bahadoris928@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Erfanian
School of Nursing and Midwifery, Ibn Sina Street, Doctor's Crossroad, University Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 ErfanianF@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Written consent to participate in the study Have minimum literacy Resident of Mashhad Married and age range 15-49 Absence, no use of special medicine in the last two weeks No allergy to clotrimazole and jujube No pregnancy or breastfeeding No use of IUD and hormonal contraceptive method No recurrent vulvovaginitis candidiasis No use of oral and topical antifungal (vaginal candidiasis treatment) At least a score of 3 from the total score of symptoms of vaginal candidiasis Bell (according to the questionnaire) Positive test answer from the candidate's point of view 15 years 49 years Female Occurrence of pregnancy Forgetting medication more than once Allergy to given medication Use of other antifungals Monthly habit during the study period Intimacy without using condom Withdrawal from participation in the research by the research unit B37.3 Candidiasis of vulva and vagina Treatment - Drugs Treatment - Drugs For one week, treated with 3% jujube vaginal cream and 1% clotrimazole, one applicator every night Control group: treated with clotrimazole 1% vaginal cream, one applicator every night for one week Vaginal candidiasis. Timepoint: One week ± 24 hours. Method of measurement: Culture of vaginal secretions in the laboratory. Itching. Timepoint: Before treatment, one week ± 24 hours after treatment. Method of measurement: Patient history. Erythema. Timepoint: Before treatment, one week ± 24 hours after treatment. Method of measurement: Patient history. Burning. Timepoint: Before treatment, one week ± 24 hours after treatment. Method of measurement: Patient history. Dys paranoia. Timepoint: Before treatment, one week ± 24 hours after treatment. Method of measurement: Patient history. The result of the culture of vaginal secretions. Timepoint: Before treatment, one week ± 24 hours after treatment. Method of measurement: Patient history. Mashhad University of Medical Sciences Approved 2023-07-11 Ethics Committee of Mashhad University of Medical Sciences University Street, Doctor's Crossroad, Ibn Sina Street, Faculty of Nursing and Midwifery Mashhad Razavi Khorasan Iran (Islamic Republic of)