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OpenTrials
Completed

NCT Number: NCT03005353

Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.

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.

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Key information

Conditions

Infection, Fungal Bacterial Infections and Mycoses Infections Mycoses

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assiut University

Asyut, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Cumin seed extract

Drug

patients will receive the drug in suppository form

clotrimazole

Drug

patients will receive the drug in suppository form

Primary outcomes

  1. The percentage of patients with complete cure

    Time frame: one week

    cure is defines as absence of symptoms

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 29, 2016
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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