Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.

Randomized Clinical Trial for 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.

Study Overview

• Status: Completed
• Conditions: Infection, Fungal
• Intervention / Treatment: Drug: Cumin seed extract; Drug: clotrimazole

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cumin seed extract; Group A (study group) will receive Cumin seed extract vaginal suppositories once daily for 7 days.	Drug: Cumin seed extract; patients will receive the drug in suppository form
Active Comparator: clotrimazole; Group B will receive conventional clotrimazole vaginal suppositories once daily for 7 days.	Drug: clotrimazole; patients will receive the drug in suppository form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of patients with complete cure	cure is defines as absence of symptoms	one week

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: December 23, 2016
• First Submitted That Met QC Criteria: December 23, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 7, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Candidiasis; Mycoses; Vulvovaginitis; Candidiasis, Vulvovaginal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Clotrimazole; Miconazole
• Other Study ID Numbers: CSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No