<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/NCT03019861</url>
  </required_header>
  <id_info>
    <org_study_id>AYURDA</org_study_id>
    <nct_id>NCT03019861</nct_id>
  </id_info>
  <brief_title>Ayurvedic Nutritional Counseling for Patients With IBS in Comparison to Conventional Nutritional Counseling</brief_title>
  <acronym>AYURDA</acronym>
  <official_title>Randomized Controlled Study on Ayurvedic Nutritional Counseling for Patients With Irritable Bowel Syndrome in Comparison to Conventional Nutritional Counseling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <brief_summary>
    <textblock>
      The main goal of this randomized controlled clinical study is to evaluate the efficacy of an&#xD;
      individual Ayurvedic nutritional counseling (according to tradition) compared to an&#xD;
      individual conventional dietary advice (according to the German Nutrition Society - DGE) in&#xD;
      patients with irritable bowel syndrome. It is to be investigated whether nutritional therapy&#xD;
      elements, which patients can self-implement independently in the home environment, can&#xD;
      achieve sustainable therapy effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">February 2019</completion_date>
  <primary_completion_date type="Actual">October 2018</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change</measure>
    <time_frame>Change from IBS-SSS Baseline at 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cohen Perceived Stress Scale (CPSS) - Change</measure>
    <time_frame>Change from CPSS Baseline at 4 weeks, 12 weeks and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS-D) - Change</measure>
    <time_frame>Change from HADS-D Baseline at 4 weeks, 12 weeks and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change</measure>
    <time_frame>Change from IBS-QOL Baseline at 4 weeks, 12 weeks and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS: Pain, Sleep, General bothersomeness, Expectation - Change</measure>
    <time_frame>Change from VAS Baseline at 4 weeks, 12 weeks and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change</measure>
    <time_frame>Change from IBS-SSS Baseline at 4 weeks and 6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Stool analysis: Intestinal microbiome by sequencing 16S rRNA</measure>
    <time_frame>Baseline, 4 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Qualitative interviews in focus groups</measure>
    <time_frame>Baseline, 6 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>IBS - Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Ayurvedic nutritional counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive three Ayurvedic nutritional counselings (according to tradition) after 1, 3 and 8 weeks after Baseline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional nutritional counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive three conventional nutritional counselings (according to German Nutrition Society - DGE) after 1, 3 and 8 weeks after Baseline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Ayurvedic nutritional counseling</intervention_name>
    <arm_group_label>Ayurvedic nutritional counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional nutritional counseling</intervention_name>
    <arm_group_label>Conventional nutritional counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis &quot;irritable bowel syndrome&quot; according to the ROM-III criteria and the German&#xD;
             S3 guideline (Layer 2011)&#xD;
&#xD;
          -  Female and male patients between 18 and 70 years of age&#xD;
&#xD;
          -  Declaration of consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bad general condition&#xD;
&#xD;
          -  Serious acute or chronic comorbidity&#xD;
&#xD;
          -  Pregnancy and breast feeding period&#xD;
&#xD;
          -  Eating disorder&#xD;
&#xD;
          -  In recognition procedures for early retirement or disability&#xD;
&#xD;
          -  Simultaneous participation in another clinical trial&#xD;
&#xD;
          -  Participation in a clinical trial within the last 3 months before enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Michalsen, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charité University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kliniken Essen-Mitte</name>
      <address>
        <city>Essen</city>
        <state>Am Deimelsberg 34 A</state>
        <zip>45276</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus</name>
      <address>
        <city>Berlin</city>
        <zip>14109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>August 2, 2021</last_update_submitted>
  <last_update_submitted_qc>August 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Andreas Michalsen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Ayurveda</keyword>
  <keyword>IBS</keyword>
  <keyword>Complementary medicine</keyword>
  <keyword>nutritional counseling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT03019861
org study id: AYURDA
nct id: NCT03019861
lead sponsor: 
The main goal of this randomized controlled clinical study is to evaluate the efficacy of an
      individual Ayurvedic nutritional counseling (according to tradition) compared to an
      individual conventional dietary advice (according to the German Nutrition Society - DGE) in
      patients with irritable bowel syndrome. It is to be investigated whether nutritional therapy
      elements, which patients can self-implement independently in the home environment, can
      achieve sustainable therapy effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change
time frame: Change from IBS-SSS Baseline at 12 weeks
measure: Cohen Perceived Stress Scale (CPSS) - Change
time frame: Change from CPSS Baseline at 4 weeks, 12 weeks and 6 months
measure: Hospital Anxiety and Depression Scale (HADS-D) - Change
time frame: Change from HADS-D Baseline at 4 weeks, 12 weeks and 6 months
measure: Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change
time frame: Change from IBS-QOL Baseline at 4 weeks, 12 weeks and 6 months
measure: VAS: Pain, Sleep, General bothersomeness, Expectation - Change
time frame: Change from VAS Baseline at 4 weeks, 12 weeks and 6 months
measure: Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change
time frame: Change from IBS-SSS Baseline at 4 weeks and 6 months
measure: Stool analysis: Intestinal microbiome by sequencing 16S rRNA
time frame: Baseline, 4 weeks
measure: Qualitative interviews in focus groups
time frame: Baseline, 6 months
arm group label: Ayurvedic nutritional counseling
arm group type: Active Comparator
description: Patients will receive three Ayurvedic nutritional counselings (according to tradition) after 1, 3 and 8 weeks after Baseline.
arm group label: Conventional nutritional counseling
arm group type: Active Comparator
description: Patients will receive three conventional nutritional counselings (according to German Nutrition Society - DGE) after 1, 3 and 8 weeks after Baseline.
intervention type: Behavioral
intervention name: Ayurvedic nutritional counseling
arm group label: Ayurvedic nutritional counseling
intervention type: Behavioral
intervention name: Conventional nutritional counseling
arm group label: Conventional nutritional counseling
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Andreas Michalsen, Prof. Dr.
role: Principal Investigator
affiliation: Charité University Medical Center
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Andreas Michalsen
investigator title: Principal Investigator
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome