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

Phase 3

Not yet recruiting

• Conditions: Acute vaginitis. Ayurveda Condition: KAPAJA-YONIROGAH,

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

Brief Summary

This study is a randomized, open label,comparative, parallel-group trial comparing the safety and efficacyof castor oil EMULGEL compared to clotrimazole 200mg vaginal tablet in thetreatment of 80 subjects with vulvo-vaginal candidiasis that will beconducted at D.Y.Patil Hospital, Navi Mumbai. The primary outcome measures willbe therapeutic cure at follow up visit (Day 4 for clotrimazole and Day 6 forcastor oil). The secondary outcomes will be:

1.  Microbiological cure rate (Directmicroscopy/wet smear): Number of positive findings in direct microscopy incomparison to first visit.

2. Therapeutic cure rate: Clinical andmicrobiological cure combined.

3. Total Severity Score (TSS): Individual clinicalsigns and symptoms.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-05
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• Pregnant or lactating women.
• Patients with history of previous treatment with systemic antifungal agents within past four weeks or previous topical antifungal treatment within one week.
• Having any sexually transmitted disease or gynecological abnormality requiring treatment.
• History of diabetes mellitus or other chronic illness.
• Immunocompromised patients or patients on immunosuppressant therapy.
• Presence of concomitant vaginitis caused by other infections (e.g., Bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis or Neisseria gonorrhea).
• Hypersensitivity to azoles or any component of the formulation.
• History of drug or alcohol dependency or abuse.
• 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

Primary Outcome Measures

Name	Time	Method
Clinical cure rate (proportion of participants achieving clinical cure)	At baseline, Day-4 for Clotrimazole 200mg & Day 6 for Castor oil EMULGEL

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

D.Y.Patil Hospital; 🇮🇳 Thane, MAHARASHTRA, India

D.Y.Patil Hospital

🇮🇳Thane, MAHARASHTRA, India

DR SAYALI PATIL

Principal investigator

9158960386

patilsayali5796@gmail.com