xml: <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/NCT06004362</url>
    </required_header>
    <id_info>
      <org_study_id>NHKOnline</org_study_id>
      <nct_id>NCT06004362</nct_id>
    </id_info>
    <brief_title>Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome After COVID-19</brief_title>
    <official_title>Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome - a Randomized-controlled Mixed-methods Trial.</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>
    <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>
        The Post-COVID syndrome is a COVID-19 sequelae disease with high individual burden. We&#xD;
        conduct a prospective, two-arm, randomized-controlled intervention study with embedded&#xD;
        qualitative and physiological sub-studies in a mixed-methods design.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 4, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">July 2025</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>Short Form 36 (SF-36), Physical Functioning Scale</measure>
      <time_frame>Baseline, 10 weeks</time_frame>
      <description>The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Short Form 36 (SF-36)</measure>
      <time_frame>Baseline, 10 weeks, 4 months, 6 months, 12 months</time_frame>
      <description>The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DePaul Post-Exertional Malaise Questionnaire (DSQ-PEM)</measure>
      <time_frame>Baseline, 10 weeks, 4 months, 6 months, 12 months</time_frame>
      <description>The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-COVID-Syndrom (PCS) Score</measure>
      <time_frame>Baseline, 10 weeks, 4 months, 6 months, 12 months</time_frame>
      <description>The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Chalder Fatigue Scale (CFS)</measure>
      <time_frame>Baseline, 10 weeks, 4 months, 6 months, 12 months</time_frame>
      <description>The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life (EQ-5D-5L)</measure>
      <time_frame>Baseline, 10 weeks, 4 months, 6 months, 12 months</time_frame>
      <description>The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General Self-Efficacy Scale (GSE, German version: ASKU)</measure>
      <time_frame>Baseline, 10 weeks, 4 months, 6 months, 12 months</time_frame>
      <description>The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analog scale (VAS) physical strength</measure>
      <time_frame>Baseline, 10 weeks, 4 months, 6 months, 12 months</time_frame>
      <description>The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analog scale (VAS) mental strength</measure>
      <time_frame>Baseline, 10 weeks, 4 months, 6 months, 12 months</time_frame>
      <description>The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analog scale (VAS) headache</measure>
      <time_frame>Baseline, 10 weeks, 4 months, 6 months, 12 months</time_frame>
      <description>The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire 9 (PHQ9)</measure>
      <time_frame>Baseline, 10 weeks, 4 months, 6 months, 12 months</time_frame>
      <description>The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>Baseline, 10 weeks, 4 months, 6 months, 12 months</time_frame>
      <description>The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lifestyle questions (diet, alcohol, cigarettes, relaxation, hydrotherapie, nature stays, physical activity)</measure>
      <time_frame>Baseline, 10 weeks, 4 months, 6 months, 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Expectation regarding study intervention</measure>
      <time_frame>Baseline</time_frame>
      <description>5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Stress Scale (PSS 4)</measure>
      <time_frame>Baseline, 10 weeks, 4 months, 6 months, 12 months</time_frame>
      <description>The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction with the intervention</measure>
      <time_frame>Week 10</time_frame>
      <description>5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety by recording adverse events</measure>
      <time_frame>Baseline, 10 weeks, 4 months, 6 months, 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence to the study intervention</measure>
      <time_frame>Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10</time_frame>
      <description>Asking Minutes (min.) of the last week</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Online diaries for assessing routine care (GP prescriptions/measures, especially medication and phytotherapy/nutritional supplements)</measure>
      <time_frame>Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, 4 months, 6 months, 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Continuation of the intervention</measure>
      <time_frame>4 months, 6 months, 12 months</time_frame>
      <description>Asking Minutes (min.) of the last month</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Qualitative data</measure>
      <time_frame>Week 10</time_frame>
      <description>After the end of the intervention, qualitative data will be collected at week 10 from a randomized subpopulation (n=15-20) for the purpose of evaluating the online intervention from the patient's perspective using semi-structured, guided interviews with narrative components (of interest, for example, are the subjective experiences, the experience of the disease and its effects).</description>
    </other_outcome>
    <other_outcome>
      <measure>Sub-study: Focus group interviews with physicians</measure>
      <time_frame>Week 10</time_frame>
      <description>In a sub-study, focus group interviews will be conducted with n=7-10 primary care physicians in routine care. Depending on the research results, the number and structure of the interviews and the interviewed patients can be adapted according to the explorative requirements of the qualitative analysis. The interviews will be digitally recorded, pseudonymously transcribed and qualitatively analyzed.</description>
    </other_outcome>
    <other_outcome>
      <measure>Sub-study: biosignal characteristics</measure>
      <time_frame>Baseline, week 10</time_frame>
      <description>In another subgroup (electrophysiological sub-study) with n=48 participants, multichannel electrophysiological measurements are performed in each case at baseline and week 10, in which heart rate, blood pressure, respiratory rate, pulse, electrodermal activity and brain activity (EEG) are recorded synchronously - by means of monitoring systems (SOMNOmedics, SOMNO HD EEG 32) and Corsano Smartwatch. Furthermore, hand force is measured in a standardized way.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Post-COVID Syndrome</condition>
    <arm_group>
      <arm_group_label>Complementary and Integrative Medicine online intervention, routine care and book</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Routine care and book</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Complementary and Integrative Medicine online intervention, routine care and book</intervention_name>
      <description>The online program takes place in a multiprofessionally guided online group setting once a week for up to 180 minutes (including several breaks) over a period of 10 weeks:&#xD;
  Basic principles of a plant-based whole-food nutrition&#xD;
  Procedures of hydrotherapy according to Kneipp&#xD;
  Self-help strategies (e.g. teas, wraps, compresses etc.)&#xD;
  Methods of mind-body medicine (mindfulness, meditation, breathing, yoga etc.)&#xD;
  Methods of extended Complementary and Integrative Medicine (e.g. acupressure)&#xD;
  It is recommended to practice a part of the taught exercises at home for about 30 minutes daily. In addition, the patients receive a book for the treatment of post-covid syndrome complaints. Group 1 additionally uses the already existing routine care (e.g. general practitioner).</description>
      <arm_group_label>Complementary and Integrative Medicine online intervention, routine care and book</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Routine care and book</intervention_name>
      <description>Participants in the second study arm receive routine care, e.g. from their general practitioner. In addition, the patients receive the same book as group 1 for the treatment of post-covid syndrome complaints. The participants of the second study arm will be offered to participate in the Complementary and Integrative Medicine online intervention after 4 months within the study.</description>
      <arm_group_label>Routine care and book</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Acute SARS-CoV2 infection at least 12 weeks ago (documented by PCR test results or&#xD;
               SARS-CoV-2 antibodies)&#xD;
  &#xD;
            -  History of chronic fatigue (after SARS-CoV-2 infection)&#xD;
  &#xD;
            -  At least 3 of 7 criteria fulfilled at the time of inclusion: sleep disturbance,&#xD;
               headache, joint pain/muscle pain, anxiety/depression, memory impairment/concentration&#xD;
               disturbance, postexertional malaise, dysosmia/anosmia&#xD;
  &#xD;
            -  Numerical Rating Scale (NRS, 0-10 points, 0 = not able to exercise at all; 10 = full&#xD;
               exercise capacity) physical exercise capacity of max. 6 points (&quot;What is your physical&#xD;
               exercise capacity on average over the last 7 days?&quot;)&#xD;
  &#xD;
            -  Short Form-36 Physical Function Subscale (SF-36 PFS) of maximum 65 points&#xD;
  &#xD;
            -  Patient are technically equipped enough to participate in the online intervention and&#xD;
               willing to follow the study procedure to perform the online intervention at home&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Fatigue already present before SARS-CoV-2 infection&#xD;
  &#xD;
            -  Presence of severe post-exertional malaise (PEM) (according to DSQ-PEM tool question 7&#xD;
               OR 8 with yes AND &gt;14h condition worsening)&#xD;
  &#xD;
            -  Other underlying conditions leading to symptoms of chronic fatigue, such as unstable&#xD;
               mental illness, oncological disease(s), MS, fibromyalgia, and substance abuse&#xD;
  &#xD;
            -  Other serious underlying medical conditions, such as severe pulmonary, cardiac,&#xD;
               psychiatric, or infectious diseases that could interfere with study participation or&#xD;
               affect results • Ongoing opioid therapy or opioid therapy in the week prior to study&#xD;
               entry&#xD;
  &#xD;
            -  Regular use of cannabinoids or other illicit drugs in the month prior to or during the&#xD;
               study&#xD;
  &#xD;
            -  Restarting or discontinuing psychotherapy during study participation in the 6 weeks&#xD;
               prior to study entry&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  Participation in another clinical intervention study during study participation 1&#xD;
  &#xD;
            -  Regular use of Complementary and Integrative Medicine self-help measures (e.g.&#xD;
               meditation, Kneipp hydrotherapiy, etc.) within the study period&#xD;
  &#xD;
            -  Current pension procedure or planned claiming of a pension procedure due to disability&#xD;
  &#xD;
            -  Planned rehabilitation measures during study participation due to post-COVID syndrome&#xD;
  &#xD;
          Inclusion and exclusion criteria of the sub-study focus group interviews with physicians&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            -  Family physicians and general practitioners&#xD;
  &#xD;
            -  Regular outpatient care of patients with post-covid syndrome&#xD;
  &#xD;
            -  Willingness in principle to participate in a 2-hour interview on-site or online&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
          • No previous care of post-covid patients&#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_contact>
      <last_name>Miriam Rösner</last_name>
      <phone>004980505682</phone>
      <email>naturheilkunde.studien@immanuel.de</email>
    </overall_contact>
    <location>
      <facility>
        <name>Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus</name>
        <address>
          <city>Berlin</city>
          <zip>14109</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Miriam Rösner, Study nurse</last_name>
        <phone>00493080505682</phone>
        <email>naturheilkunde.studien@immanuel.de</email>
      </contact>
      <investigator>
        <last_name>Andreas Michalsen, Prof. Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004362
  org study id: NHKOnline
  nct id: NCT06004362
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The Post-COVID syndrome is a COVID-19 sequelae disease with high individual burden. We
        conduct a prospective, two-arm, randomized-controlled intervention study with embedded
        qualitative and physiological sub-studies in a mixed-methods design.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Short Form 36 (SF-36), Physical Functioning Scale
  time frame: Baseline, 10 weeks
  description: The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
  measure: Short Form 36 (SF-36)
  time frame: Baseline, 10 weeks, 4 months, 6 months, 12 months
  description: The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
  measure: DePaul Post-Exertional Malaise Questionnaire (DSQ-PEM)
  time frame: Baseline, 10 weeks, 4 months, 6 months, 12 months
  description: The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
  measure: Post-COVID-Syndrom (PCS) Score
  time frame: Baseline, 10 weeks, 4 months, 6 months, 12 months
  description: The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
  measure: Chalder Fatigue Scale (CFS)
  time frame: Baseline, 10 weeks, 4 months, 6 months, 12 months
  description: The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
  measure: Quality of life (EQ-5D-5L)
  time frame: Baseline, 10 weeks, 4 months, 6 months, 12 months
  description: The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
  measure: General Self-Efficacy Scale (GSE, German version: ASKU)
  time frame: Baseline, 10 weeks, 4 months, 6 months, 12 months
  description: The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
  measure: Visual analog scale (VAS) physical strength
  time frame: Baseline, 10 weeks, 4 months, 6 months, 12 months
  description: The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
  measure: Visual analog scale (VAS) mental strength
  time frame: Baseline, 10 weeks, 4 months, 6 months, 12 months
  description: The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
  measure: Visual analog scale (VAS) headache
  time frame: Baseline, 10 weeks, 4 months, 6 months, 12 months
  description: The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
  measure: Patient Health Questionnaire 9 (PHQ9)
  time frame: Baseline, 10 weeks, 4 months, 6 months, 12 months
  description: The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
  measure: Pittsburgh Sleep Quality Index (PSQI)
  time frame: Baseline, 10 weeks, 4 months, 6 months, 12 months
  description: The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
  measure: Lifestyle questions (diet, alcohol, cigarettes, relaxation, hydrotherapie, nature stays, physical activity)
  time frame: Baseline, 10 weeks, 4 months, 6 months, 12 months
  measure: Expectation regarding study intervention
  time frame: Baseline
  description: 5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level.
  measure: Perceived Stress Scale (PSS 4)
  time frame: Baseline, 10 weeks, 4 months, 6 months, 12 months
  description: The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
  measure: Satisfaction with the intervention
  time frame: Week 10
  description: 5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level.
  measure: Safety by recording adverse events
  time frame: Baseline, 10 weeks, 4 months, 6 months, 12 months
  measure: Adherence to the study intervention
  time frame: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
  description: Asking Minutes (min.) of the last week
  measure: Online diaries for assessing routine care (GP prescriptions/measures, especially medication and phytotherapy/nutritional supplements)
  time frame: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, 4 months, 6 months, 12 months
  measure: Continuation of the intervention
  time frame: 4 months, 6 months, 12 months
  description: Asking Minutes (min.) of the last month
  measure: Qualitative data
  time frame: Week 10
  description: After the end of the intervention, qualitative data will be collected at week 10 from a randomized subpopulation (n=15-20) for the purpose of evaluating the online intervention from the patient's perspective using semi-structured, guided interviews with narrative components (of interest, for example, are the subjective experiences, the experience of the disease and its effects).
  measure: Sub-study: Focus group interviews with physicians
  time frame: Week 10
  description: In a sub-study, focus group interviews will be conducted with n=7-10 primary care physicians in routine care. Depending on the research results, the number and structure of the interviews and the interviewed patients can be adapted according to the explorative requirements of the qualitative analysis. The interviews will be digitally recorded, pseudonymously transcribed and qualitatively analyzed.
  measure: Sub-study: biosignal characteristics
  time frame: Baseline, week 10
  description: In another subgroup (electrophysiological sub-study) with n=48 participants, multichannel electrophysiological measurements are performed in each case at baseline and week 10, in which heart rate, blood pressure, respiratory rate, pulse, electrodermal activity and brain activity (EEG) are recorded synchronously - by means of monitoring systems (SOMNOmedics, SOMNO HD EEG 32) and Corsano Smartwatch. Furthermore, hand force is measured in a standardized way.
  arm group label: Complementary and Integrative Medicine online intervention, routine care and book
  arm group type: Experimental
  arm group label: Routine care and book
  arm group type: Active Comparator
  intervention type: Behavioral
  intervention name: Complementary and Integrative Medicine online intervention, routine care and book
  description: The online program takes place in a multiprofessionally guided online group setting once a week for up to 180 minutes (including several breaks) over a period of 10 weeks:
  Basic principles of a plant-based whole-food nutrition
  Procedures of hydrotherapy according to Kneipp
  Self-help strategies (e.g. teas, wraps, compresses etc.)
  Methods of mind-body medicine (mindfulness, meditation, breathing, yoga etc.)
  Methods of extended Complementary and Integrative Medicine (e.g. acupressure)
  It is recommended to practice a part of the taught exercises at home for about 30 minutes daily. In addition, the patients receive a book for the treatment of post-covid syndrome complaints. Group 1 additionally uses the already existing routine care (e.g. general practitioner).
  arm group label: Complementary and Integrative Medicine online intervention, routine care and book
  intervention type: Behavioral
  intervention name: Routine care and book
  description: Participants in the second study arm receive routine care, e.g. from their general practitioner. In addition, the patients receive the same book as group 1 for the treatment of post-covid syndrome complaints. The participants of the second study arm will be offered to participate in the Complementary and Integrative Medicine online intervention after 4 months within the study.
  arm group label: Routine care and book
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Miriam Rösner
  phone: 004980505682
  email: naturheilkunde.studien@immanuel.de
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Germany
  responsible party type: Principal Investigator
  investigator affiliation: Charite University, Berlin, Germany
  investigator full name: Andreas Michalsen
  investigator title: Principal Investigator
  mesh term: Syndrome
  sharing ipd: Undecided