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

Phase 3

• Conditions: Health Condition 1: N760- Acute vaginitis

• Registration Number: CTRI/2023/04/051978
• Lead Sponsor: D Y Patil University School of Medicine Navi Mumbai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified