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Trial record 6 of 27 for:    Clotrimazole AND Fungal Infections

Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Cream.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03005353
Recruitment Status : Recruiting
First Posted : December 29, 2016
Last Update Posted : June 27, 2018
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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 Cream.
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Arm Intervention/treatment
Experimental: Cumin seed extract
Group A (study group) will receive Cumin seed extract vaginal cream 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 cream once daily for 7 days.
Drug: clotrimazole
patients will receive the drug in suppository form
Other Name: Gyno-Daktarin

Primary Outcome Measures :
  1. The percentage of patients with complete cure [ Time Frame: one week ]
    cure is defines as absence of symptoms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03005353

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Assiut University Recruiting
Assiut, Egypt
Contact: Ahmed Abbas, MD    00201003385183   
Sponsors and Collaborators
Assiut University

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Responsible Party: Ahmed Mohamed Abbas, Dr, Assiut University Identifier: NCT03005353     History of Changes
Other Study ID Numbers: CSE
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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:
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Candidiasis, Vulvovaginal
Vaginal Diseases
Genital Diseases, Female
Vulvar Diseases