Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infection, Fungal

Treatments: Drug: clotrimazole; Drug: Cumin seed extract

Study type: Interventional

Funder types: Other

Identifiers

NCT03005353

CSE

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Cumin seed extract

Experimental group

Description:

Group A (study group) will receive Cumin seed extract vaginal suppositories once daily for 7 days.

Treatment:

Drug: Cumin seed extract

clotrimazole

Active Comparator group

Description:

Group B will receive conventional clotrimazole vaginal suppositories once daily for 7 days.

Treatment:

Drug: clotrimazole