Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.

Phase 2

Completed

• Conditions: Infection, Fungal
• Interventions: Drug: Cumin seed extract; Drug: clotrimazole

• Registration Number: NCT03005353
• Lead Sponsor: Assiut University

Brief Summary

Fungal infections have increased over the last two decades, largely because of the increasing size of the population at risk, including patients who are immunocompromised, broad-spectrum antibiotics and intravascular catheter users. Essential oils and other extracts of plants have evoked interest as sources of natural products. They have been shown to possess antibacterial, antifungal, antiviral, insecticidal and antioxidant properties. To the best of our knowledge, no study has examined the efficacy of cumin seed extract on relieving vulvovaginal candidiasis in vivo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-23
• Study First Submitted QC: 2016-12-23
• Study First Posted: 2016-12-29
• Study Start: 2018-03-01
• Primary Completion: 2019-10-31
• Study Completion: 2020-01-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-07
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Women were 18-49 years old and were married;
2. They had not used antibiotics, immunosuppressive drugs, or vaginal drugs 14 days before the study;
3. They did not suffer from trichomonal vaginitis, bacterial vaginitis, or cervicitis based on direct smear;
4. Candidiasis culture was in agreement with clinical symptoms and patient's complaints.

Exclusion Criteria

1. Pregnant and lactating women;
2. Those who had abnormal uterine bleeding;
3. Women with diabetes or autoimmune diseases;
4. Women refuse to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cumin seed extract	Cumin seed extract	Group A (study group) will receive Cumin seed extract vaginal suppositories once daily for 7 days.
clotrimazole	clotrimazole	Group B will receive conventional clotrimazole vaginal suppositories once daily for 7 days.

Primary Outcome Measures

Name	Time	Method
The percentage of patients with complete cure	one week	cure is defines as absence of symptoms

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt