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IRCT20110826007418N5 IRCT 2021-03-03 Tabriz University of Medical Sciences omparing the effect of probiotic and fluconazole in treatment and recurrent of vaginal candidiasis: A three-blind randomised controlled trial Comparing the effect of probiotic and fluconazole in treatment and recurrent of vaginal candidiasis: A three-blind randomised controlled trial 2021-03-10 anticipated 80 Complete https://irct.ir/trial/50819 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: Placement of individuals in groups is done randomly using a computer random table through random blocking of four and six and clients in a ratio of 1: 1 allocation to two groups (recipient of fluconazole tablets and probiotic placebo and recipient of probiotic capsules and Fluconazole placebo) Similar glasses are prepared in terms of appearance, the contents of which are also not visible, and each glass contains contains 30 capsules and one tablet and includes two types: the first type contains one pink fluconazole tablet 150mg and 30 capsules 500mg of probiotic placebo, and the second contains The second type contains 30 500mg probiotic capsules and one 150mg fluconazole placebo tablet. Fluconazole placebo is pink. Random allocation will be provided by the person not involved in the sampling. In order to Allocation Concealement, the drugs will be placed in numbered consecutive frosted jars and delivered to participants in the order in which they enter the study, Blinding description: Similar glasses are prepared in terms of appearance, the contents of which are also not visible, and each glass contains contains 30 capsules and one tablet and includes two types: the first type contains one pink fluconazole tablet 150mg and 30 capsules 500mg of probiotic placebo, and the second contains The second type contains 30 500mg probiotic capsules and one 150mg fluconazole placebo tablet. Fluconazole placebo is pink. Random allocation will be provided by the person not involved in the sampling. In order to Allocation Concealement, the drugs will be placed in numbered consecutive frosted jars and delivered to participants in the order in which they enter the study. 3 vaginal candidiasis. Intervention 1: First intervention group :Take one dose of 150 mg fluconazole tablets and then a daily 500 mg probiotic placebo capsule (containing starch and made by the researcher) for one month. Day 12-15 Phone follow-up will be done and in addition to emphasizing the regular use of prescribed drugs and other instructions, the candidiasis symptoms questionnaire will be completed by phone. The first and second follow-up (in person) is 35-40 days and 60-65 days after the start of treatment. From the pH meter paper, the vaginal pH is determined and recorded in a checklist, and a sample will be taken from the vaginal canal for laboratory culture. Intervention 2: The second intervention group: Take one dose of 150 mg placebo fluconazole tablets (which contain starch and will be made by the researcher) and then take a daily probiotic capsule containing containing Lactobacillus acidophilus daily at a dose of 〖10〗^9 CFU/g CFU / g for one month (Probiotic powder is prepared in the order of the researcher from Hansen company in 25 gram packages and is poured into the capsule by the relevant personnel in Tabriz School of Pharmacy and Medical Sciences.). Day 12-15 Phone follow-up will be done and in addition to emphasizing the regular use of prescribed drugs and other instructions, the candidiasis symptoms questionnaire will be completed by phone. The first and second follow-up (in person) is 35-40 days and 60-65 days after the start of treatment. From the pH meter paper, the vaginal pH is determined and recorded in a checklist, and a sample will be taken from the vaginal canal for laboratory culture. Yes - There is a plan to make this available What will be shared: All data sets are to be shared after deidentified IPD. When: Data will become available 6 months after publication. To whom: data is available for people working in academic institutions. Conditions: Obligation to observe ethics. Where to obtain: E-mail: yavarikiap@tbzmed.ac.ir How to obtain: A request to access data/document will be respond during one week. Comments:
public Zahra Mollazadeh Narestan
Nursing & Midwifery Faculty, South Shariati Street Tabriz
Tabriz Iran (Islamic Republic of) 5138947-977 +98 41 3479 0364 zahra.m8565@gmail.com Tabriz University of Medical Sciences scientific Parisa Yavarikia
Nursing & Midwifery Faculty, South Shariati, Tabriz
Tabriz Iran (Islamic Republic of) 5138947-977 +98 41 3479 6770 yavarikiap@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Married women aged 15-49 (lack of virginity) Positive culture of discharge from the candidate's point of view Be literate Willingness to participate in the study and the possibility of visiting the clinic at the requested times Having a contact phone Living in the city of Tabriz 15 years 49 years Female Pregnancy, lactation and menopause Use of antibiotics and immunosuppressive drugs (corticosteroids, etc.) and use of vaginal drugs during the last two weeks Currently taking oral contraceptives according to the participant Having autoimmune diseases Having chronic diseases such as diabetes, anemia, hypothyroidism, etc. Having menstrual bleeding during the visit of the participant Abnormal uterine bleeding Non-candidal vaginitis Recurrent vulvovaginitis (four or more cases during the year) Symptoms of drug allergy Consumption of any probiotic product (supplements, food, etc.) B37.3 Candidiasis of vulva and vagina Treatment - Drugs Treatment - Drugs First intervention group :Take one dose of 150 mg fluconazole tablets and then a daily 500 mg probiotic placebo capsule (containing starch and made by the researcher) for one month. Day 12-15 Phone follow-up will be done and in addition to emphasizing the regular use of prescribed drugs and other instructions, the candidiasis symptoms questionnaire will be completed by phone. The first and second follow-up (in person) is 35-40 days and 60-65 days after the start of treatment. From the pH meter paper, the vaginal pH is determined and recorded in a checklist, and a sample will be taken from the vaginal canal for laboratory culture. The second intervention group: Take one dose of 150 mg placebo fluconazole tablets (which contain starch and will be made by the researcher) and then take a daily probiotic capsule containing containing Lactobacillus acidophilus daily at a dose of 〖10〗^9 CFU/g CFU / g for one month (Probiotic powder is prepared in the order of the researcher from Hansen company in 25 gram packages and is poured into the capsule by the relevant personnel in Tabriz School of Pharmacy and Medical Sciences.). Day 12-15 Phone follow-up will be done and in addition to emphasizing the regular use of prescribed drugs and other instructions, the candidiasis symptoms questionnaire will be completed by phone. The first and second follow-up (in person) is 35-40 days and 60-65 days after the start of treatment. From the pH meter paper, the vaginal pH is determined and recorded in a checklist, and a sample will be taken from the vaginal canal for laboratory culture. Frequency of negative culture in two intervention groups. Timepoint: Day 40-35 after starting treatment and day 65-60 after starting treatment. Method of measurement: Cultivation in the laboratory. Patients complain of foul-smelling discharge. Timepoint: Day 35-40 and day 60-65 after starting treatment. Method of measurement: Questionnaire of signs and symptoms of the person. Patients complain of itching. Timepoint: Day 35-40 and day 60-65 after starting treatment. Method of measurement: Questionnaire of signs and symptoms of the person. Patients complain of burning. Timepoint: Day 35-40 and day 60-65 after starting treatment. Method of measurement: Questionnaire of signs and symptoms of the person. Patients complain of inflammation and vaginal erythema. Timepoint: Day 35-40 and day 60-65 after starting treatment. Method of measurement: Questionnaire of signs and symptoms of the person. Patients complain of frequent urination. Timepoint: Day 35-40 and day 60-65 after starting treatment. Method of measurement: Questionnaire of signs and symptoms of the person. Patients complain of urinary incontinence. Timepoint: Day 35-40 and day 60-65 after starting treatment. Method of measurement: Questionnaire of signs and symptoms of the person. Patients complain of pain during intercourse. Timepoint: Day 35-40 and day 60-65 after starting treatment. Method of measurement: Questionnaire of signs and symptoms of the person. Vaginal pH. Timepoint: Day 35-40 and day 60-65 after starting treatment. Method of measurement: Checklist for recording observations and clinical results. Satisfaction rate. Timepoint: Day 35-40 after starting treatment. Method of measurement: Personal Satisfaction Questionnaire. Adverse events during the intervention. Timepoint: Any time of study. Method of measurement: Checklist for side effects. Tabriz University of Medical Sciences Approved 2020-12-07 Ethics committee of Tabriz University of Medical Sciences Nursing & Midwifery Faculty, South Shariati Streetwifery, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)