<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03005353</url>
  </required_header>
  <id_info>
    <org_study_id>CSE</org_study_id>
    <nct_id>NCT03005353</nct_id>
  </id_info>
  <brief_title>Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.</brief_title>
  <official_title>Randomized Clinical Trial for Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fungal infections have increased over the last two decades, largely because of the increasing&#xD;
      size of the population at risk, including patients who are immunocompromised, broad-spectrum&#xD;
      antibiotics and intravascular catheter users. Essential oils and other extracts of plants&#xD;
      have evoked interest as sources of natural products. They have been shown to possess&#xD;
      antibacterial, antifungal, antiviral, insecticidal and antioxidant properties. To the best of&#xD;
      our knowledge, no study has examined the efficacy of cumin seed extract on relieving&#xD;
      vulvovaginal candidiasis in vivo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of patients with complete cure</measure>
    <time_frame>one week</time_frame>
    <description>cure is defines as absence of symptoms</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Infection, Fungal</condition>
  <arm_group>
    <arm_group_label>Cumin seed extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A (study group) will receive Cumin seed extract vaginal suppositories once daily for 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>clotrimazole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group B will receive conventional clotrimazole vaginal suppositories once daily for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cumin seed extract</intervention_name>
    <description>patients will receive the drug in suppository form</description>
    <arm_group_label>Cumin seed extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>clotrimazole</intervention_name>
    <description>patients will receive the drug in suppository form</description>
    <arm_group_label>clotrimazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women were 18-49 years old and were married;&#xD;
&#xD;
          2. They had not used antibiotics, immunosuppressive drugs, or vaginal drugs 14 days&#xD;
             before the study;&#xD;
&#xD;
          3. They did not suffer from trichomonal vaginitis, bacterial vaginitis, or cervicitis&#xD;
             based on direct smear;&#xD;
&#xD;
          4. Candidiasis culture was in agreement with clinical symptoms and patient's complaints.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant and lactating women;&#xD;
&#xD;
          2. Those who had abnormal uterine bleeding;&#xD;
&#xD;
          3. Women with diabetes or autoimmune diseases;&#xD;
&#xD;
          4. Women refuse to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>June 7, 2020</last_update_submitted>
  <last_update_submitted_qc>June 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Mohamed Abbas</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycoses</mesh_term>
    <mesh_term>Candidiasis, Vulvovaginal</mesh_term>
    <mesh_term>Vulvovaginitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clotrimazole</mesh_term>
    <mesh_term>Miconazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03005353
org study id: CSE
nct id: NCT03005353
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: The percentage of patients with complete cure
time frame: one week
description: cure is defines as absence of symptoms
arm group label: Cumin seed extract
arm group type: Experimental
description: Group A (study group) will receive Cumin seed extract vaginal suppositories once daily for 7 days.
arm group label: clotrimazole
arm group type: Active Comparator
description: Group B will receive conventional clotrimazole vaginal suppositories once daily for 7 days.
intervention type: Drug
intervention name: Cumin seed extract
description: patients will receive the drug in suppository form
arm group label: Cumin seed extract
intervention type: Drug
intervention name: clotrimazole
description: patients will receive the drug in suppository form
arm group label: clotrimazole
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Mohamed Abbas
investigator title: Dr
mesh term: Mycoses
mesh term: Candidiasis, Vulvovaginal
mesh term: Vulvovaginitis
mesh term: Clotrimazole
mesh term: Miconazole
sharing ipd: No