Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03005353
Recruitment Status : Recruiting
First Posted : December 29, 2016
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Tracking Information
First Submitted Date  ICMJE December 23, 2016
First Posted Date  ICMJE December 29, 2016
Last Update Posted Date June 27, 2018
Actual Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2017)
The percentage of patients with complete cure [ Time Frame: one week ]
cure is defines as absence of symptoms
Original Primary Outcome Measures  ICMJE
 (submitted: December 23, 2016)
The percentage of patients with complete cure [ Time Frame: one week ]
Change History Complete list of historical versions of study NCT03005353 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2016)
2. The types of Candida species isolated in vitro and their susceptibility to cumin seed extract. [ Time Frame: 24 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Cream.
Official Title  ICMJE Randomized Clinical Trial for Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Cream.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Infection, Fungal
Intervention  ICMJE
  • Drug: Cumin seed extract
    patients will receive the drug in suppository form
  • Drug: clotrimazole
    patients will receive the drug in suppository form
    Other Name: Gyno-Daktarin
Study Arms  ICMJE
  • Experimental: Cumin seed extract
    Group A (study group) will receive Cumin seed extract vaginal cream once daily for 7 days.
    Intervention: Drug: Cumin seed extract
  • Active Comparator: clotrimazole
    Group B will receive conventional clotrimazole vaginal cream once daily for 7 days.
    Intervention: Drug: clotrimazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 23, 2016)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03005353
Other Study ID Numbers  ICMJE CSE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Ahmed Mohamed Abbas, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP