<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/NCT04492787</url>
  </required_header>
  <id_info>
    <org_study_id>TSL-TCM-CKKL-Ⅱ</org_study_id>
    <nct_id>NCT04492787</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Changkang Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)</brief_title>
  <official_title>A Randomized,Double-blind,Placebo-controlled,Multicenter Study to Evaluate the Efficacy and Safety of Changkang Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tasly Pharmaceutical Group Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tasly Pharmaceutical Group Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the efficacy and safety of Changkang granule as compared&#xD;
      to placebo over a 8-week treatment period and explore TCM syndrome types.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical phase of the study comprises up to 2 weeks of screening for patient's&#xD;
      eligibility, a 2-week run-in period , a 8-week double-blind treatment period, and a 4-week&#xD;
      safety follow-up.&#xD;
&#xD;
      Patients report their IBS-related symptoms daily from run-in until end of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 6, 2020</start_date>
  <completion_date type="Anticipated">October 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Are Composite Responders Consistency Scores</measure>
    <time_frame>8 week</time_frame>
    <description>Composite responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval.&#xD;
The patient will be considered a weekly responder if she/he meets both of the following criteria in the same week.&#xD;
Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline;&#xD;
Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Are Responders in Abdominal Pain Scores</measure>
    <time_frame>8 week</time_frame>
    <description>Abdominal pain responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval; Weekly response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Are Responders in Stool Consistency Scores</measure>
    <time_frame>8 week</time_frame>
    <description>Stool consistency responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval.&#xD;
Weekly response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to each week during follow up for IBS-symptoms abdominal pain；</measure>
    <time_frame>8 week</time_frame>
    <description>Abdominal Pain：Scored between 0 and 10 (none to severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to each week during follow up for IBS-symptoms stool consistency;</measure>
    <time_frame>8 week</time_frame>
    <description>Stool consistency：Bristol Stool Scale（Scored 1-7）.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to each week during follow up for IBS-symptoms bloating</measure>
    <time_frame>8 week</time_frame>
    <description>Bloating：Scored between 0 and 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to each week during follow up for IBS-symptoms urgency</measure>
    <time_frame>8 week</time_frame>
    <description>The change of frequency of defecation urgency per week compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to each week during follow up for IBS-symptoms Defecation frequency</measure>
    <time_frame>8 week</time_frame>
    <description>Change from baseline in mean number of bowel movements per week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disappearance rate of traditional Chinese Medicine（TCM）symptom</measure>
    <time_frame>8 week</time_frame>
    <description>Each syndrome type has 2-3 symptoms，liver Qi multiplying spleen syndrome includes Chest and flank fullness, depression, irritability</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Irritable Bowel Syndrome With Diarrhea</condition>
  <arm_group>
    <arm_group_label>Changkang Granules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Changkang Granules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Changkang Placebo Granules</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Changkang Placebo Granules</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Changkang Granule</intervention_name>
    <description>Take Changkang granule before meals twice a day , one bag for each time</description>
    <arm_group_label>Changkang Granules</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Changkang Placebo Granule</intervention_name>
    <description>Take Changkang Placebo granule before meals twice a day , one bag for each time</description>
    <arm_group_label>Changkang Placebo Granules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patients with diarrhea predominant irritable bowel syndrome (IBS-D) met Rome IV&#xD;
             criteria;&#xD;
&#xD;
          2. It is in accordance with the syndrome differentiation standard of TCM, such as the&#xD;
             syndrome of liver Qi multiplying spleen, spleen stomach weakness, spleen kidney yang&#xD;
             deficiency or large intestine damp heat syndrome;&#xD;
&#xD;
          3. Male or female aged 18 to 65 years (including the boundary value);&#xD;
&#xD;
          4. The weekly mean NRS score of abdominal pain was ≥ 3.0, and the number of days with&#xD;
             stool type 6 or 7 was more than 2 days per week;&#xD;
&#xD;
          5. IBS-SSS score&gt;175;&#xD;
&#xD;
          6. Signed informed consent voluntarily.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with IBS-C、IBS-M or IBS-U；&#xD;
&#xD;
          2. Those who had been diagnosed with organic diseases of digestive system, such as&#xD;
             inflammatory bowel disease, intestinal tuberculosis, intestinal tumor, etc., or still&#xD;
             combined with peptic ulcer and infectious diarrhea;&#xD;
&#xD;
          3. Patients were diagnosed with similar symptoms of irritable bowel syndrome in the past,&#xD;
             such as eosinophilic enteritis, collagen enteritis, lactose intolerance, etc;&#xD;
&#xD;
          4. Patients with non intestinal diseases of digestive system, such as tuberculous&#xD;
             peritonitis, gallstones, liver cirrhosis, chronic pancreatitis, etc;&#xD;
&#xD;
          5. Previous diagnosis of systemic diseases affecting gastrointestinal function, such as&#xD;
             hyperthyroidism or hypothyroidism, endometriosis, chronic renal insufficiency,&#xD;
             autoimmune diseases, diabetes, etc&#xD;
&#xD;
          6. With history of abdominal surgery (e.g., cholecystectomy);&#xD;
&#xD;
          7. Patients with severe cardiovascular disease, liver, kidney and other major organ&#xD;
             diseases, hematopoietic system diseases, tumor, nervous or mental system diseases&#xD;
             (such as severe depression, severe anxiety)&#xD;
&#xD;
          8. Those who could not stop using concomitant drugs (prokinetic agents, anticholinergics,&#xD;
             calcium channel blockers, 5-HT3 receptor antagonists, antidiarrheal agents, antacids,&#xD;
             antidepressants, antianxiety drugs, intestinal flora regulators, etc.) that affected&#xD;
             gastrointestinal motility and function ;&#xD;
&#xD;
          9. Taking emergency medication in the run-in period；&#xD;
&#xD;
         10. Pregnant or lactating women；&#xD;
&#xD;
         11. Those who are allergic to the test drug, emergency drug and its ingredients；&#xD;
&#xD;
         12. Suspected or confirmed history of alcohol and drug abuse;&#xD;
&#xD;
         13. Patients who participated in other clinical trials within one month before enrollment;&#xD;
&#xD;
         14. The researchers believe that others are not suitable for clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rui Liu</last_name>
    <phone>022-86343724</phone>
    <email>liurui@tasly.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xiyuan Hospital, China Academy of Traditional Chinese Medicine</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hua Zhen Li, director</last_name>
      <phone>13671157196</phone>
      <email>lixingka@aliyun.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital of China Medical University</name>
      <address>
        <city>Dalian</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ning Su Chen, director</last_name>
      <phone>18940251919</phone>
      <email>chensn@sj-hospital.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gansu Provincial Hospital of TCM</name>
      <address>
        <city>Gansu</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dong Xu Tian, director</last_name>
      <phone>15002591589</phone>
      <email>xytxd@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The first affiliated Hospital of Hunan University of Traditional Chinese Medicine</name>
      <address>
        <city>Hunan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bin Yu, director</last_name>
      <phone>13507314549</phone>
      <email>Yubin410@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Biao Gong, director</last_name>
      <phone>18801800616</phone>
      <email>rachel_1983@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>West China Hospital of Sichuan University</name>
      <address>
        <city>Sichuan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hua Mei Wan, vice-director</last_name>
      <phone>13980082219</phone>
      <email>meihuawan@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wenzhou Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Wenzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming Yao Zeng, director</last_name>
      <phone>13867704929</phone>
      <email>250858111@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xiamen Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Xiamen</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bin Yi Chen, director</last_name>
      <phone>18950126702</phone>
      <email>chenyb2004@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Changkang Granule</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>
    <mesh_term>Diarrhea</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/NCT04492787
org study id: TSL-TCM-CKKL-Ⅱ
nct id: NCT04492787
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the efficacy and safety of Changkang granule as compared
      to placebo over a 8-week treatment period and explore TCM syndrome types.
The clinical phase of the study comprises up to 2 weeks of screening for patient's
      eligibility, a 2-week run-in period , a 8-week double-blind treatment period, and a 4-week
      safety follow-up.

      Patients report their IBS-related symptoms daily from run-in until end of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Who Are Composite Responders Consistency Scores
time frame: 8 week
description: Composite responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval.
The patient will be considered a weekly responder if she/he meets both of the following criteria in the same week.
Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline;
Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.
measure: Percentage of Participants Who Are Responders in Abdominal Pain Scores
time frame: 8 week
description: Abdominal pain responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval; Weekly response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline.
measure: Percentage of Participants Who Are Responders in Stool Consistency Scores
time frame: 8 week
description: Stool consistency responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval.
Weekly response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.
measure: Change from baseline to each week during follow up for IBS-symptoms abdominal pain；
time frame: 8 week
description: Abdominal Pain：Scored between 0 and 10 (none to severe).
measure: Change from baseline to each week during follow up for IBS-symptoms stool consistency;
time frame: 8 week
description: Stool consistency：Bristol Stool Scale（Scored 1-7）.
measure: Change from baseline to each week during follow up for IBS-symptoms bloating
time frame: 8 week
description: Bloating：Scored between 0 and 10.
measure: Change from baseline to each week during follow up for IBS-symptoms urgency
time frame: 8 week
description: The change of frequency of defecation urgency per week compared with baseline.
measure: Change from baseline to each week during follow up for IBS-symptoms Defecation frequency
time frame: 8 week
description: Change from baseline in mean number of bowel movements per week.
measure: Disappearance rate of traditional Chinese Medicine（TCM）symptom
time frame: 8 week
description: Each syndrome type has 2-3 symptoms，liver Qi multiplying spleen syndrome includes Chest and flank fullness, depression, irritability
arm group label: Changkang Granules
arm group type: Experimental
description: Changkang Granules
arm group label: Changkang Placebo Granules
arm group type: Placebo Comparator
description: Changkang Placebo Granules
intervention type: Drug
intervention name: Changkang Granule
description: Take Changkang granule before meals twice a day , one bag for each time
arm group label: Changkang Granules
intervention type: Drug
intervention name: Changkang Placebo Granule
description: Take Changkang Placebo granule before meals twice a day , one bag for each time
arm group label: Changkang Placebo Granules
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Rui Liu
phone: 022-86343724
email: liurui@tasly.com
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome
mesh term: Diarrhea