Comparative study between castor oil EMULGEL with clotrimazole vaginal tablet in the treatment of subjects with vulvo-vaginal candidiasis.

An open label, randomized, parallel group, comparative study to evaluate efficacy and safety of castor oil EMULGEL compared to clotrimazole vaginal tablet in the treatment of subjects with vulvo-vaginal candidiasis. - -

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051978

Enrollment

Registered

2023-04-26

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: N760- Acute vaginitis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female patients in reproductive age group (18-45 years). 2. Patients willing to give written informed consent. 3. Patients with clinical signs and symptoms of vulvovaginal candidiasis (complaints of vaginal pruritus, burning sensation, vulvar soreness or thick curdy discharge).

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women. 2. Patients with history of previous treatment with systemic antifungal agents within past four weeks or previous topical antifungal treatment within one week. 3. Having any sexually transmitted disease or gynecological abnormality requiring treatment. 4. History of diabetes mellitus or other chronic illness. 5. Immunocompromised patients or patients on immunosuppressant therapy. 6. Presence of concomitant vaginitis caused by other infections (e.g., Bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis or Neisseria gonorrhea). 7. Hypersensitivity to azoles or any component of the formulation. 8. History of drug or alcohol dependency or abuse. 9. Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or scheduled to do the same during the course of this study.

Design outcomes

Primary

Measure	Time frame
Clinical cure rate (proportion of participants achieving clinical cure)Timepoint: At baseline, Day-4 for Clotrimazole 200mg & Day 6 for Castor oil EMULGEL	—

Secondary

Measure	Time frame
1. Microbiological cure rate (Direct microscopy/wet smear): Number of positive findings in direct microscopy in comparison to first visit. 2. Therapeutic cure rate: Clinical and microbiological cure combined. 3. Total Severity Score (TSS): Individual clinical signs and symptoms. 4. Vaginal pH: Mean vaginal pH in comparison to first visit. 5. Patients satisfaction: Patient will be asked how satisfied she was with the treatment received based on 8 standardized questions. Timepoint: Castor oil EMULGEL- Day-0 First visit- Day-6 end of treatment. Clotrimazole 200mg - Day-0 First visit- Day-4 end of treatment.	—

Measure

Time frame

1. Microbiological cure rate (Direct microscopy/wet smear): Number of positive findings in direct microscopy in comparison to first visit. 2. Therapeutic cure rate: Clinical and microbiological cure combined. 3. Total Severity Score (TSS): Individual clinical signs and symptoms. 4. Vaginal pH: Mean vaginal pH in comparison to first visit. 5. Patients satisfaction: Patient will be asked how satisfied she was with the treatment received based on 8 standardized questions. Timepoint: Castor oil EMULGEL- Day-0 First visit- Day-6 end of treatment. Clotrimazole 200mg - Day-0 First visit- Day-4 end of treatment.

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Countries

India

Contacts

Public ContactDr Sayali Patil

D.Y.Patil University- School of Medicine

patilsayali5796@gmail.com9158960386

Outcome results