Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03005353
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 23
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection, Fungal	Drug: Cumin seed extract; Drug: clotrimazole	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized Clinical Trial for Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.
• Actual Study Start Date: Mar 1, 2018
• Actual Primary Completion Date: Oct 31, 2019
• Actual Study Completion Date: Jan 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The percentage of patients with complete cure [one week]

   cure is defines as absence of symptoms

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Mohamed Abbas, Dr, Assiut University
• ClinicalTrials.gov Identifier: NCT03005353
• Other Study ID Numbers: CSE
• First Posted: Dec 29, 2016
• Last Update Posted: Jun 9, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Mycoses; Candidiasis, Vulvovaginal; Vulvovaginitis; Clotrimazole; Miconazole

Study Results

No Results Posted as of Jun 9, 2020