Back to resultsTreatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.
Primary Purpose
Infection, Fungal
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Cumin seed extract
clotrimazole
Sponsored by
About this trial
This is an interventional treatment trial for Infection, Fungal
Eligibility Criteria
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.
Sites / Locations
- Assiut University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cumin seed extract
clotrimazole
Arm Description
Group A (study group) will receive Cumin seed extract vaginal suppositories once daily for 7 days.
Group B will receive conventional clotrimazole vaginal suppositories once daily for 7 days.
Outcomes
Primary Outcome Measures
The percentage of patients with complete cure
cure is defines as absence of symptoms
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03005353
Brief Title
Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.
Official Title
Randomized Clinical Trial for Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Fungal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cumin seed extract
Arm Type
Experimental
Arm Description
Group A (study group) will receive Cumin seed extract vaginal suppositories once daily for 7 days.
Arm Title
clotrimazole
Arm Type
Active Comparator
Arm Description
Group B will receive conventional clotrimazole vaginal suppositories once daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
Cumin seed extract
Intervention Description
patients will receive the drug in suppository form
Intervention Type
Drug
Intervention Name(s)
clotrimazole
Intervention Description
patients will receive the drug in suppository form
Primary Outcome Measure Information:
Title
The percentage of patients with complete cure
Description
cure is defines as absence of symptoms
Time Frame
one week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.
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