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IRCT20190711044176N1 IRCT 2019-07-26 Tehran University of Medical Sciences Therapeutic effects of Dosin (Nigella sativa and Honey) vaginal Cream on Candida Vulvovaginitis Comparison of the therapeutic effect of Honey and Nigella sativa (Dosin) vaginal cream and Clotrimazole vaginal cream in treatment Candida Vulvovaginitis 2019-07-23 anticipated 84 Complete https://irct.ir/trial/40791 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: the research units were divided into two groups of intervention and control, using four-dimensional permutation blocks. First, 6 possible blocks are listed (AABB, ABAB, BBAA, BABA, ABBA, BAAB) and each block is assigned a number from one to six. Then they are randomly assigned to the experimental and control groups using a random number table from one to six, followed by a block based on the number chosen. This will continue until the sample size is complete, Blinding description: The patient is asked to fill out the letter of consent to participate in the study and simple randomly is assigned to two groups, case and control. Clotrimazole Vaginal cream and Honey and Nigella Sativa Vaginal cream are packaged similarly and is marked "A" and "B" by a pharmacist.Creams are applied each night as an applicator (5 g) inside the vagina for 7 nights. Samples, research group, and statistical analysis are unaware of the content of cream. the present study is conducted as a Triple-blind study. 2-3 Candida VulvoVaginitis. Intervention 1: Intervention group: Intervention group: honey and Nigella Sativa"Dosin" vaginal cream each night as an applicator inside the vagina for 7 nights. Intervention 2: Control group: Control group: Clotrimazole vaginal cream each night as an applicator inside the vagina for 7 nights. 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 "No more information".
public Masoumeh Norouzi
PO Box 6459,Dr Mirkhani St.(Eastern Nusrat),Tohid Square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4215 norouzi7378@gmail.com Tehran University of Medical Sciences scientific Dr Seyedeh Tahereh Mirmolaei
East Nosrat Avenue, Towhid square, Nursing and Midwifery Faculty, Tehran University Of Medical Science
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4215 mirmolaei@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Women were married and aged between 18-49 years old Not being pregnancy Not being lactation Not Having Allergy to Honey or Nigella Sativa or Clotrimazole Not being period Not using vaginal cream and vaginal doush and for last 48 hours before the study Not Having of history of diabetes and deficiency of immune system Not Having recurrent Candida vaginitis (4 or more Candida vaginitis in a year) Not Having of history of curettage, Hysterosalpingography and uterine surgery in the last two weeks No history of receiving blood or chemotherapy in a recent month Having of signs and symptoms of Candida vaginitis, positive direct smear and culther of vaginal discharge 18 years 49 years Female Not Agreeing to Participate in the Study The use of antibiotics to treat non-vaginitis systemic infections during treatment Participation at another trial Pregnancy in the study time table B37.3 Candidiasis of vulva and vagina (N77.1*) Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: honey and Nigella Sativa"Dosin" vaginal cream each night as an applicator inside the vagina for 7 nights. Control group: Control group: Clotrimazole vaginal cream each night as an applicator inside the vagina for 7 nights. Symptoms and signs of Candida Vulvovaginitis. Timepoint: Before intervention, 6-10 day after treatment. Method of measurement: Questionnaire,Microscopic evaluation,Secretion culture,Measurements Of Ph. Improve Of Candida Vulvovaginitis. Timepoint: 6-10 Day After Treatment. Method of measurement: Questionnaire, culther. Tehran University of Medical Sciences Approved 2019-07-09 The ethics Commitee of the Faculty of Nursing and Midwifery,Tehran University of Medical Science PO Box 6459,Dr Mirkhani St.(Eastern Nusrat),Tohid Square Tehran Tehran Iran (Islamic Republic of)