Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.

NCT03005353 — Phase 2 / Phase 3, Completed, 100 participants, Assiut University

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

Registry	NCT03005353
Status	Completed
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	100 (Actual)
Sponsor	Assiut University (Other)
Conditions	Infection, Fungal
Interventions	Cumin seed extract, clotrimazole (Drug)
Dates	start 2018-03-01, primary completion 2019-10-31, completion 2020-01-31, first posted 2016-12-29, last updated 2020-06-09
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Cumin seed extract	Experimental	Drug: Cumin seed extract	Group A (study group) will receive Cumin seed extract vaginal suppositories once daily for 7 days.
clotrimazole	Active comparator	Drug: clotrimazole	Group B will receive conventional clotrimazole vaginal suppositories once daily for 7 days.

Cumin seed extract (Drug): patients will receive the drug in suppository form
clotrimazole (Drug): patients will receive the drug in suppository form

+Outcome measures

Primary outcomes

The percentage of patients with complete cure [one week]: cure is defines as absence of symptoms

+Eligibility

Sex: Female, ages: 18 Years to 49 Years

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.

+Locations (1)

Facility	City	Country	Status
Assiut University	Asyut	Egypt

My Notes

Public

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