<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/NCT03780621</url>
  </required_header>
  <id_info>
    <org_study_id>EP-1004</org_study_id>
    <nct_id>NCT03780621</nct_id>
  </id_info>
  <brief_title>Effects of an Adaptogenic Extract on Electrical Activity of the Brain in Elderly Subjects With Cognitive Impairment</brief_title>
  <official_title>Effects of an Adaptogenic Extract on Electrical Activity of Brain in Elderly Subjects With Cognitive Impairment: a Randomized, Double Blind, Placebo-controlled, Two Arms Cross-over Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EuroPharma, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EuroPharma, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, double-blind, placebo-controlled, two arm cross-over study to determine whether&#xD;
      a specific combination of Andrographis paniculata and Withania somnifera can be regarded as a&#xD;
      safe and effective treatment for cognitive deficits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change over time in neural electrical activity of the brain as measured by quantitative-topographic EEG for herbal treatment group versus placebo</measure>
    <time_frame>Four weeks</time_frame>
    <description>Responses of electric brain activity as spectral power in 17 different brain regions within 6 specially defined frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) during the test of cognitive performance: d2-test for attention (d2-Test), memory test (ME-Test), concentration-performance-test with financial reward (CPT-Test).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Cognitive Impairment, Mild</condition>
  <arm_group>
    <arm_group_label>Andrographis and Withania</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active ingredient: 550 mg of Andrographis paniculata (standardized to 40 mg andrographolides) and Withania somnifera (standardized to 10 mg withanolides) taken twice daily, once in the morning and once in the evening</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>550 mg capsule visually identical to the active dietary supplement, containing brown sugar, microcrystalline cellulose, corn starch, and magnesium stearate</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Andrographis and Withania</intervention_name>
    <description>Combination of Andrographis paniculata and Withania somnifera</description>
    <arm_group_label>Andrographis and Withania</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Visually identical placebo capsule</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female volunteers suffering from cognitive deficits.&#xD;
&#xD;
          -  Questionnaire-DemTect. &quot;DemTect&quot; (for pre-selection of subjects) - score values 8-12&#xD;
             are regarded as conclusive.&#xD;
&#xD;
          -  Age between 60 and 75 years (both included).&#xD;
&#xD;
          -  Subjects should be right-handed.&#xD;
&#xD;
          -  Subject must be capable of giving informed consent.&#xD;
&#xD;
          -  Acceptance of written consent to participate in the study after instruction in written&#xD;
             and oral form (informed consent).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with acute or chronic diseases that are relevant to the study and asked for&#xD;
             by the study staff are excluded.&#xD;
&#xD;
          -  Acute or chronic disease with an impact on the study, which becomes obvious by case&#xD;
             history or clinical examination.&#xD;
&#xD;
          -  Clinically relevant allergic symptoms.&#xD;
&#xD;
          -  Detection of alcohol at the time of initial examination (day SC) or on study day A&#xD;
             (positive alcohol test) or by case history.&#xD;
&#xD;
          -  Consumption of clinically relevant medication during last 14 days before and during&#xD;
             the active study period based on the notification of the subject or his case history.&#xD;
&#xD;
          -  Consumption of medication with primarily central action (i.e. psychotropic drugs or&#xD;
             centrally acting antihypertensive drugs). Known intolerance / hypersensitivity&#xD;
             (allergy) to plant derived extracts or any of the ingredients of the investigational&#xD;
             product (anamnestic).&#xD;
&#xD;
          -  Presence of a rare, genetic disease such as fructose intolerance, glucose-galactose&#xD;
             malabsorption or sucrose-isomaltase deficiency (anamnestic).&#xD;
&#xD;
          -  Consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea&#xD;
             (more than 4 cups a day).&#xD;
&#xD;
          -  Detection of alcohol at the time of initial examination as well as on day A, B, C and&#xD;
             D (alcohol test).&#xD;
&#xD;
          -  Smoking in the study center on study days A, B, C and D.&#xD;
&#xD;
          -  Result of the DemTect Questionnaire score &lt;8 or &gt;12.&#xD;
&#xD;
          -  Participation in another clinical trial within the last 60 days.&#xD;
&#xD;
          -  Bad compliance.&#xD;
&#xD;
          -  Cancellation of informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Klaus Koch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NeuroCode AG</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Labors of NeuroCode AG</name>
      <address>
        <city>Wetzlar</city>
        <zip>D-35578</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>November 13, 2019</last_update_submitted>
  <last_update_submitted_qc>November 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Electroencephalography</keyword>
  <keyword>Andrographis</keyword>
  <keyword>Ashwagandha</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Andrographolide</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/NCT03780621
org study id: EP-1004
nct id: NCT03780621
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A randomized, double-blind, placebo-controlled, two arm cross-over study to determine whether
      a specific combination of Andrographis paniculata and Withania somnifera can be regarded as a
      safe and effective treatment for cognitive deficits.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change over time in neural electrical activity of the brain as measured by quantitative-topographic EEG for herbal treatment group versus placebo
time frame: Four weeks
description: Responses of electric brain activity as spectral power in 17 different brain regions within 6 specially defined frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) during the test of cognitive performance: d2-test for attention (d2-Test), memory test (ME-Test), concentration-performance-test with financial reward (CPT-Test).
arm group label: Andrographis and Withania
arm group type: Experimental
description: Active ingredient: 550 mg of Andrographis paniculata (standardized to 40 mg andrographolides) and Withania somnifera (standardized to 10 mg withanolides) taken twice daily, once in the morning and once in the evening
arm group label: Placebo
arm group type: Placebo Comparator
description: 550 mg capsule visually identical to the active dietary supplement, containing brown sugar, microcrystalline cellulose, corn starch, and magnesium stearate
intervention type: Dietary Supplement
intervention name: Andrographis and Withania
description: Combination of Andrographis paniculata and Withania somnifera
arm group label: Andrographis and Withania
intervention type: Dietary Supplement
intervention name: Placebo
description: Visually identical placebo capsule
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: No
last name: Klaus Koch, MD
role: Principal Investigator
affiliation: NeuroCode AG
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
mesh term: Andrographolide
sharing ipd: No