Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.

NCT03005353 | Completed Phase 2 DMC

• 1 other identifier: CSE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection, Fungal

Outcome Measures

Primary Outcomes (1)

• The percentage of patients with complete cure

  cure is defines as absence of symptoms

  one week

Study Arms (2)

Cumin seed extract

EXPERIMENTAL

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

Drug: Cumin seed extract

clotrimazole

ACTIVE COMPARATOR

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

Drug: clotrimazole

Interventions

Cumin seed extract DRUG

patients will receive the drug in suppository form

Cumin seed extract

clotrimazole DRUG

patients will receive the drug in suppository form

clotrimazole

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

MeSH Terms

Conditions

Mycoses

Interventions

Clotrimazole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 23, 2016
• First Posted: December 29, 2016
• Study Start: March 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: January 31, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)