<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/NCT03300804</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00041236</org_study_id>
    <secondary_id>1U19AT003266-01</secondary_id>
    <nct_id>NCT03300804</nct_id>
  </id_info>
  <brief_title>Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome (TCM- IBS)</brief_title>
  <acronym>TCM-IBS</acronym>
  <official_title>Dose Escalation Trial Of Traditional Chinese Medicine For Irritable Bowel Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a 20- herb formulation, as a well&#xD;
      characterised extract, is efficacious in treating irritable bowel syndrome (IBS) and also to&#xD;
      identify efficacious and safe dosage of the formulation in treating IBS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Specific aims of the project are:&#xD;
&#xD;
        1. To determine whether a 20- herb formulation improves pain/ discomfort and disturbed&#xD;
           bowel frequency in patients with Irritable Bowel Syndrome who have been disappointed&#xD;
           with current conventional Western medicine.&#xD;
&#xD;
        2. To identify an optimal dosage of the 20- herb formulation that is safe and well&#xD;
           tolerated for up to 8 weeks of treatment, among 2 dosages. This is determined by relief&#xD;
           of symptoms of IBS in a dose escalation, placebo-controlled double- blind randomized&#xD;
           clinical trial, in conjunction with indices of safety and tolerability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2008</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">March 2011</primary_completion_date>
  <phase>Phase 2</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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global IBS symptom improvement</measure>
    <time_frame>8 weeks</time_frame>
    <description>The primary endpoint for this study is the efficacy at the 8 week followup visit of the herbal formulations, which is defined by the patient's global assessment of the IBS symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Bowel Symptom Scale (BSS):</measure>
    <time_frame>8 weeks</time_frame>
    <description>The Bowel Symptom Scale will be used to assess changes in individual IBS and global IBS symptoms during the course of illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36</measure>
    <time_frame>8 weeks</time_frame>
    <description>Quality of Life generic (SF-36), will be used for assessment of quality of life in response to treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IBS-QoL</measure>
    <time_frame>8 weeks</time_frame>
    <description>Disease-specific (IBS-QoL) will be used for assessment of quality of life in response to treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>20-herb formulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active herb</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo herb formulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>20-herb formulation</intervention_name>
    <description>Two daily dosages will be investigated. The lowest dosage condition will be 17gm daily, followed by an escalation to 34gm. Participants will be treated for 8 weeks</description>
    <arm_group_label>20-herb formulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo herb formulation</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18- 75&#xD;
&#xD;
          -  All IBS patients attending the Gastroenterology Clinic of the Prince Of Wales Hospital&#xD;
             of Hong Kong.&#xD;
&#xD;
          -  IBS diagnosed by Rome III criteria:&#xD;
&#xD;
               -  Recurrent abdominal pain or discomfort at least three days per month in the&#xD;
                  previous three months&#xD;
&#xD;
               -  Symptoms onset at least six months prior to diagnose&#xD;
&#xD;
               -  Pain or discomfort associated with two or more of the following:&#xD;
&#xD;
                    1. Improvement with defecation&#xD;
&#xD;
                    2. Onset associated with change in frequency of stool&#xD;
&#xD;
                    3. Onset associated with a change in form (appearance) of stool&#xD;
&#xD;
          -  Normal colonic evaluation (colonoscopy or barium enema) in past 5 years&#xD;
&#xD;
          -  No &quot;global symptom improvement&quot; as rated by patients (see below) at screening and&#xD;
             during the two- week run- in period to baseline&#xD;
&#xD;
          -  Normal full blood count, liver function test and renal function test.&#xD;
&#xD;
               -  Informed written consent for participation into study.&#xD;
&#xD;
               -  Ethical approval will be obtained from the Joint CUHK-NTEC Clinical Research&#xD;
                  Ethics Committee as well as the IRB of UMB.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Past or present history of organic disease of gastrointestinal tract (e.g. colorectal&#xD;
             cancer, advanced colonic polyp, celiac disease, inflammatory bowel disease, peptic&#xD;
             ulcer and previous gastrointestinal surgery). (Note: those with polyps removed during&#xD;
             colonoscopy can be included, as long as no known polyps remained.&#xD;
&#xD;
          -  Systemic diseases that cause diarrhea or constipation (e.g. thyroid disease, diabetic&#xD;
             neuropathy)&#xD;
&#xD;
          -  Lactose intolerance&#xD;
&#xD;
          -  Severe liver disease (e.g. cirrhosis, chronic active hepatitis)&#xD;
&#xD;
          -  Renal impairment (serum creatinine level &gt; 150mmol/L)&#xD;
&#xD;
          -  Women who are pregnant, lactating or not practicing proper contraception&#xD;
&#xD;
          -  Known hypersensitivity to herbal medicine&#xD;
&#xD;
          -  Concommitant use of prescription antidepressant medication&#xD;
&#xD;
          -  Current alcoholism and drug use&#xD;
&#xD;
          -  Current psychiatric illness or dementia&#xD;
&#xD;
          -  Fever or severe illness at baseline (week 0).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian M Berman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Gastroenterelogy Clinic Of the Prince Of Wales, Chinese University of Hong Kong</name>
      <address>
        <city>Shatin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>March 28, 2010</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>February 25, 2022</last_update_submitted>
  <last_update_submitted_qc>February 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Brian Berman</investigator_full_name>
    <investigator_title>Director of Research Center for Integrative Medicine, University of Maryland</investigator_title>
  </responsible_party>
  <keyword>IBS</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>
  <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/NCT03300804
org study id: HP-00041236
secondary id: 1U19AT003266-01
nct id: NCT03300804
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether a 20- herb formulation, as a well
      characterised extract, is efficacious in treating irritable bowel syndrome (IBS) and also to
      identify efficacious and safe dosage of the formulation in treating IBS.
The Specific aims of the project are:

        1. To determine whether a 20- herb formulation improves pain/ discomfort and disturbed
           bowel frequency in patients with Irritable Bowel Syndrome who have been disappointed
           with current conventional Western medicine.

        2. To identify an optimal dosage of the 20- herb formulation that is safe and well
           tolerated for up to 8 weeks of treatment, among 2 dosages. This is determined by relief
           of symptoms of IBS in a dose escalation, placebo-controlled double- blind randomized
           clinical trial, in conjunction with indices of safety and tolerability.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Global IBS symptom improvement
time frame: 8 weeks
description: The primary endpoint for this study is the efficacy at the 8 week followup visit of the herbal formulations, which is defined by the patient's global assessment of the IBS symptoms.
measure: The Bowel Symptom Scale (BSS):
time frame: 8 weeks
description: The Bowel Symptom Scale will be used to assess changes in individual IBS and global IBS symptoms during the course of illness.
measure: SF-36
time frame: 8 weeks
description: Quality of Life generic (SF-36), will be used for assessment of quality of life in response to treatment.
measure: IBS-QoL
time frame: 8 weeks
description: Disease-specific (IBS-QoL) will be used for assessment of quality of life in response to treatment.
arm group label: 20-herb formulation
arm group type: Active Comparator
description: Active herb
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo herb formulation
intervention type: Drug
intervention name: 20-herb formulation
description: Two daily dosages will be investigated. The lowest dosage condition will be 17gm daily, followed by an escalation to 34gm. Participants will be treated for 8 weeks
arm group label: 20-herb formulation
intervention type: Drug
intervention name: Placebo
description: Placebo herb formulation
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Brian M Berman, MD
role: Principal Investigator
affiliation: University of Maryland
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Brian Berman
investigator title: Director of Research Center for Integrative Medicine, University of Maryland
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome
sharing ipd: No