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IRCT20120718010324N77 IRCT 2023-05-20 Tabriz University of Medical Sciences Comparing the Effects of Mycozin and Clotrimazole on Vaginal Candidiasis Comparing the Effects of Mycozin and Clotrimazole 1% on Vaginal Candidiasis: a Triple Blinded Randomized Controlled Trial 2023-05-31 anticipated 126 Complete https://irct.ir/trial/68718 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be allocated randomly into two groups receiving mycosin vaginal cream and clotrimazole vaginal cream 1% using Random Allocation Software (RAS) through four and six blocks and with a ratio of 1:1 (40 people in each group) . The type of allocation will be written on paper and placed in consecutively numbered opaque envelopes (Allocation Concealment). The envelopes will be opened in order by a person not involved in sampling, Blinding description: The participants, researcher and data analyst will be blinded completely in this study. Mycozin and Clotrimazole will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in the research. 3 Vaginal Candidiasis. Intervention 1: Intervention group 1 will use Mycozin vaginal cream at bedtime for one week. Intervention 2: Intervention group 2 will use Clotrimazole 1% vaginal cream at bedtime 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 Participant data is confidential.
public Dr Khadijeh Hajizadeh
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3475 1708 hajizade_k@yahoo.com Tabriz University of Medical Sciences scientific Dr Mojgan Mirghafourvand
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3475 1708 mirghafourvand@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age 18-45 years married Being literate in reading and writing Lack of allergy to herbal medicines Suffering from candidal vaginitis 18 years 45 years Female Suffering from chronic diseases such as diabetes, AIDS, immune system disorders, depression, etc. currently, according to the participant's statement Taking antibiotics and corticosteroids during the last two weeks according to the participant's statement Menstruation at the time of study Current use of oral contraceptives as reported by the participant The presence of a wound or mass in the cervix when viewed with a speculum Existence of severe mental stress during the last three months, such as the death of first-degree relatives Presence of pregnancy or breastfeeding at the time of study Taking other drugs to treat vaginitis Having recurrent vulvovaginitis (more than four times per year) Abnormal uterine bleeding B37.3 Candidiasis of vulva and vagina Treatment - Drugs Treatment - Drugs Intervention group 1 will use Mycozin vaginal cream at bedtime for one week. Intervention group 2 will use Clotrimazole 1% vaginal cream at bedtime for one week. Frequency of clinical symptoms (smell, quantity, consistency, color and appearance of vaginal secretions, vaginal inflammation, appearance of cervix). Timepoint: Before the intervention and 10 to 15 days after the intervention. Method of measurement: Clinical examination by the researcher and clinical symptoms checklist. Frequency of patient complaints (secretions, dysuria, frequency, itching, itching during intercourse, pain in the lower abdomen, burning sensation during intercourse, and dyspareunia). Timepoint: Before the intervention and 10 to 15 days after the intervention. Method of measurement: Stated by the participants and complaints checklist. Frequency of laboratory symptoms (negative smear and culture of vaginal secretions). Timepoint: Before the intervention and 10 to 15 days after the intervention. Method of measurement: Sampling will be done with a sterile cotton swab from the posterior fornix of the vagina, and we will dip the swab inside the blood culture tubes and gently shake it inside the solution until the sample dissolves in it. Incubation will be at 37 degrees for 2 to 4 hours, and a drop of the contents of the tube solution will be transferred on a slide. We examine the slide under the microscope with high and low magnification. Germ tube formation test is a quick test to identify Candida albicans and differentiate it from other yeasts. PH of vaginal secretions. Timepoint: Before the intervention and 10 to 15 days after the intervention. Method of measurement: PH paper. Satisfaction with the treatment. Timepoint: 10 to 15 days after the intervention. Method of measurement: Satisfaction questionnaire. Side events. Timepoint: 10 to 15 days after the intervention. Method of measurement: Side events checklist. Tabriz University of Medical Sciences Approved 2023-05-08 Ethics committee of Tabriz University of Medical Sciences Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue Tabriz East Azarbaijan Iran (Islamic Republic of)