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Study to compare the treatment of antifungal alone and antifungal with probiotics in vulvovaginal candidiasis

Antifungal treatment alone versus antifungal with probiotics in vulvovaginal candidiasiss-a randomised open label study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031155
Enrollment
60
Registered
2021-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: N768- Other specified inflammation of vagina and vulva

Interventions

Intervention1: Probiotics in addition to conventional antifungal: Conventional antifungal treatment along with probiotics will be given to those newly diagnosed vulvovaginal candidiasis and followed

Sponsors

Lady Hardinge Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All females aged 18-50 years diagnosed with vulvovaginal candidiasis. Diagnosis of VVC will be confirmed by the presence of clinical symptoms and signs, and a positive microscopic examination or positive vaginal culture or both.

Exclusion criteria

Exclusion criteria: Pregnant and lactating females. Recurrent vulvovaginal candidiasis (4 or more episodes of symptomatic vulvovaginal candidiasis within 1 year) Vaginal discharge other than those of candidiasis or mixed infection Taking any kind of treatment for vulvovaginal candidiasis/ probiotics within last one month. Other pathologies (immunodeficiency, diabetes) Patient not willing for sexual abstinence/barrier protection during the study period.

Design outcomes

Primary

MeasureTime frame
Clinical cure rate (the ratio between the number of women without vaginal discharge or itching and all women present in the treatment group)Timepoint: week 1, week 2, week 4, week 8

Secondary

MeasureTime frame
Mycological cure rate (the ratio between the number of women with negative culture and all women present in the treatment group) Relapse rate (ratio between the number of women experiencing at least one symptom during the 2-month follow-up period, confirmed by culture, and all women present in the treatment group) Time to first relapse Proportion of patient having side effects Patient assesment score in both the treatment groupTimepoint: week 1, week 2, week 4, week 8

Countries

India

Contacts

Public ContactVibhu Mendiratta

Lady Hardinge Medical college

vibhumendiratta@rediffmail.com9871016304

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026