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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110826007418N5
Enrollment
80
Registered
2021-03-03
Start date
2021-03-10
Completion date
Unknown
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vaginal candidiasis. Candidiasis of vulva and vagina

Interventions

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. Da

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 49 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.)

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Mollazadeh Narestan

Tabriz University of Medical Sciences

zahra.m8565@gmail.com+98 41 3479 0364

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 13, 2026