Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.

Infection, Fungal Clinical Trial

Official title:

Randomized Clinical Trial for Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005353
• Other study ID #: CSE
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 31, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Candidiasis, Vulvovaginal
• Infection, Fungal
• Mycoses
• Vulvovaginitis

Intervention

Drug:
• Cumin seed extract
patients will receive the drug in suppository form
• clotrimazole
patients will receive the drug in suppository form

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients with complete cure	cure is defines as absence of symptoms	one week