<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/NCT04479202</url>
  </required_header>
  <id_info>
    <org_study_id>Berberine treats COVID-19</org_study_id>
    <secondary_id>XJ2020005101</secondary_id>
    <nct_id>NCT04479202</nct_id>
  </id_info>
  <brief_title>The Effect of Berberine on Intestinal Function and Inflammatory Mediators in Severe Patients With Covid-19</brief_title>
  <acronym>BOIFIM</acronym>
  <official_title>The Effect of Berberine on Intestinal Function and Inflammatory Mediators in Severe Patients With Covid-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Medical Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese Medical Association</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>
      Coronavirus disease 2019 (COVID-19) rapidly spread across China and throughout the world,&#xD;
      causing hundreds of thousands died. Studies had shown that &quot;cytokine storms&quot; and subsequent&#xD;
      multiple organ dysfunction (MODS) are important causes for disease progression and death in&#xD;
      patients with COVID-19. Similar to SARS-CoV infection, SARS-CoV-2 would infect humans via&#xD;
      binding of S-protein to angiotensin-converting enzyme 2 (ACE2), a host cell receptor, and the&#xD;
      S protein is activated and cleaved by cellular transmembrane serine proteases, allowing the&#xD;
      virus to release fusion peptides for membrane fusion. In addition to the lungs, ACE2 is also&#xD;
      highly expressed in the esophagus, small intestine and colon, suggesting that the gut might&#xD;
      also be an important target organ for SARS-CoV-2. About 8-16% of severe pneumonia cases&#xD;
      confirmed with SARS-CoV-2 infection developed gastrointestinal symptoms such as abdominal&#xD;
      pain, vomiting, and diarrhea. Moreover, the stool of patient with COVID-19 also positive by&#xD;
      real-time reverse-transcriptase-polymerase-chain-reaction (rRT-PCR) assay. Furthermore,&#xD;
      elevated faecal calprotectin was observed in patients with COVID-19 suggested an inflammatory&#xD;
      response in the gut, which was significantly correlated with IL-6. For severe and critical&#xD;
      cases, control &quot;cytokine storms&quot; and maintain intestinal microenvironment balance have been&#xD;
      included into the Diagnosis and Treatment Guideline of patients with COVID-19 (Edition 7).&#xD;
      Berberine is a quaternary ammonium alkaloid isolated from rhizoma coptidis. It is often used&#xD;
      in treatment of infectious diarrhea by bacteriostasis and inhibition of intestinal gland&#xD;
      secretion. Berberine has also been found to have a role in intestinal immune regulation,&#xD;
      inhibiting both AP-1 and NF- B, the key factors in cell signal transduction, and reducing the&#xD;
      inflammatory response. Investigators conducted a prospective randomized controlled clinical&#xD;
      trial to investigate the effects of berberine on intestinal function, serum concentrations of&#xD;
      the inflammatory biomarkers, and organ function in severe patients with SARS-CoV-2 infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients aged 18-80 years who confirmed with COVID-19 and classified as severe were enrolled&#xD;
      in the study, and then separated randomly into two groups: a berberine group (B group) and a&#xD;
      control group (C group). The diagnostic criteria for severe cases are in accordance with the&#xD;
      Diagnosis and Treatment Guideline of patients with COVID-19 issued by the National Health&#xD;
      Commission of the People's Republic of China (Edition 7). In general, patients diagnosed with&#xD;
      COVID-19 pneumonia must also meet any of the following criteria: appears shortness of breath,&#xD;
      respiratory rate (RR) ≥ 30 times/min; SPO2 ≤ 93% at rest; the ratio of partial oxygen&#xD;
      pressure of arterial blood (PaO2) to oxygen absorption concentration (FiO2) ≤ 300mmHg&#xD;
      (1mmHg=0.133KPa); pulmonary imaging showed the lesion progression &gt;50% within 24-48 hours.&#xD;
      All enrolled patients were given general support therapy, oxygen therapy, antiviral drugs, in&#xD;
      combination with antibiotics and small doses of glucocorticoids if necessary, nutritional and&#xD;
      organ function support. Patients in the berberine group (B group) were given berberine 0.3g&#xD;
      tid orally or tube feed daily, while patients in the control group (C group) were given&#xD;
      montmorilonite orally if they presence of diarrhea. The duration of the study intervention&#xD;
      was 14 days and followed up to discharge. Investigators record general information about&#xD;
      patients at admission, including age, gender, age, exposure history, time from onset of&#xD;
      symptoms to hospital, APACHE II score, the presentation of X-ray, comorbidity, mechanical&#xD;
      ventilation, fever or not,gastrointestinal symptoms. Investigators also evaluate the&#xD;
      gastrointestinal function daily,including gastrointestinal symptoms (nausea, vomiting,&#xD;
      abdominal pain, abdominal distension or diarrhoea), frequency of diarrhea, the&#xD;
      characteristics of stool (Bristol scal). Peripheral blood are collected on day 1,3, 7 and 14&#xD;
      after admission to determine the level of interleukin-6 (IL-6), interleukin-1β (IL-1β),&#xD;
      interleukin-10 (IL-10) and tumor necrosis factor (TNF-α). Laboratory tests are also performed&#xD;
      to evaluate leucocyte, c-reactive protein (CRP), and procalcitonin (PCT) levels at the same&#xD;
      time. Glutamate transaminase (ALT), glutamate transaminase (AST), urea nitrogen (Bun),&#xD;
      creatinine, prothrombin time (PT), partially activated prothrombin time (APTT), and&#xD;
      Sequential Organ Failure Assessment (SOFA) score are used to evaluate organ function on day&#xD;
      1,3, 7 and 14 after admission. Investigators also record the adverse events associated with&#xD;
      the drug, length of stay and the prognosis at discharge. The patients are blinded to the&#xD;
      group allocation. Two physicians are responsible for data processing, one is responsible for&#xD;
      recording and collecting, and the other is responsible for checking, and they are all blind&#xD;
      to the research.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2020</start_date>
  <completion_date type="Actual">April 23, 2020</completion_date>
  <primary_completion_date type="Actual">April 18, 2020</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in diarrhea frequency and Bristol Stool Scale</measure>
    <time_frame>daily, from date of randomization until the date of discharge or date of death from any cause, assessed up to 2 weeks.</time_frame>
    <description>Including diarrhea in times/day, Bristol Stool Scale (the minimum 1 and maximum 7, a higher scores mean a worse outcome) and whether patient has any one of gastrointestinal symptoms (nausea, vomiting, abdominal pain, abdominal distension or diarrhoea).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IL-6 (ng/ml)</measure>
    <time_frame>baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause</time_frame>
    <description>evaluate inflammatory response, blood sample collected at 6:00am</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-10（ng/ml）</measure>
    <time_frame>baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause</time_frame>
    <description>evaluate inflammatory response, blood sample collected at 6:00am</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-1β (ng/ml)</measure>
    <time_frame>baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause</time_frame>
    <description>evaluate inflammatory response, blood sample collected at 6:00am</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TNF-α (pg/ml)</measure>
    <time_frame>baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause</time_frame>
    <description>evaluate inflammatory response, blood sample collected at 6:00am</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>leukocyte count (10^9/l)</measure>
    <time_frame>baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause</time_frame>
    <description>evaluate inflammatory response, blood sample collected at 6:00am</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>c reactive protein (mg/l)</measure>
    <time_frame>baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause</time_frame>
    <description>evaluate inflammatory response, blood sample collected at 6:00am</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>procalcitonin (ng/ml)</measure>
    <time_frame>baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause</time_frame>
    <description>evaluate inflammatory response, blood sample collected at 6:00am</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sequential Organ Failure Assessment (SOFA) score</measure>
    <time_frame>baseline (at admission), day 3, 7 and 14 after admission or until the date of discharge or date of death from any cause</time_frame>
    <description>evaluate the severity of the disease(the minimum 0 and maximum 24, a higher scores mean a worse outcome)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Berberine</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>berberine group (B group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the B group were given berberine hydrochloride tables 0.3g tid orally or tube feed daily, until the 14th day of the study. Other treatments include general support therapy, oxygen therapy, antiviral drugs, in combination with antibiotics and small doses of glucocorticoids if necessary, nutritional and organ function support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group (C group)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients in the C group were given montmorilonite orally if they presence of diarrhea. The other treatments were the same as in B group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Berberine</intervention_name>
    <description>Patients in the intervention group received berberine daily, regardless of gastrointestinal symptoms.If the patient has a serious drug-related adverse event, the drug will be discontinued and the patient will be excluded from the study.</description>
    <arm_group_label>berberine group (B group)</arm_group_label>
    <other_name>Berberine Hydrochloride Tablets</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Montmorrillonite</intervention_name>
    <description>Patients in the control group were routinely not given special treatment.However, if the patient has diarrhea symptoms, montmorillonite powder should be given orally.</description>
    <arm_group_label>control group (C group)</arm_group_label>
    <other_name>Montmorrillonite Powder</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients confirmed with COVID-19 and classified as severe&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inflammatory bowel disease;&#xD;
&#xD;
          -  have other sources of infection;&#xD;
&#xD;
          -  death is anticipate within 72 hours;&#xD;
&#xD;
          -  participated in other clinical trials;&#xD;
&#xD;
          -  pregnant or lactating women;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wenkui Yu, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nanjing Drum Tower Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Effenberger M, Grabherr F, Mayr L, Schwaerzler J, Nairz M, Seifert M, Hilbe R, Seiwald S, Scholl-Buergi S, Fritsche G, Bellmann-Weiler R, Weiss G, Muller T, Adolph TE, Tilg H. Faecal calprotectin indicates intestinal inflammation in COVID-19. Gut. 2020 Aug;69(8):1543-1544. doi: 10.1136/gutjnl-2020-321388. Epub 2020 Apr 20. No abstract available.</citation>
    <PMID>32312790</PMID>
  </results_reference>
  <results_reference>
    <citation>Jin X, Lian JS, Hu JH, Gao J, Zheng L, Zhang YM, Hao SR, Jia HY, Cai H, Zhang XL, Yu GD, Xu KJ, Wang XY, Gu JQ, Zhang SY, Ye CY, Jin CL, Lu YF, Yu X, Yu XP, Huang JR, Xu KL, Ni Q, Yu CB, Zhu B, Li YT, Liu J, Zhao H, Zhang X, Yu L, Guo YZ, Su JW, Tao JJ, Lang GJ, Wu XX, Wu WR, Qv TT, Xiang DR, Yi P, Shi D, Chen Y, Ren Y, Qiu YQ, Li LJ, Sheng J, Yang Y. Epidemiological, clinical and virological characteristics of 74 cases of coronavirus-infected disease 2019 (COVID-19) with gastrointestinal symptoms. Gut. 2020 Jun;69(6):1002-1009. doi: 10.1136/gutjnl-2020-320926. Epub 2020 Mar 24.</citation>
    <PMID>32213556</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.</citation>
    <PMID>32171076</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastrointestinal function</keyword>
  <keyword>inflammatory biomarkers</keyword>
  <keyword>Organ function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bentonite</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We have other articles about covid-19 yet to be published</ipd_description>
  </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/NCT04479202
org study id: Berberine treats COVID-19
secondary id: XJ2020005101
nct id: NCT04479202
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Coronavirus disease 2019 (COVID-19) rapidly spread across China and throughout the world,
      causing hundreds of thousands died. Studies had shown that "cytokine storms" and subsequent
      multiple organ dysfunction (MODS) are important causes for disease progression and death in
      patients with COVID-19. Similar to SARS-CoV infection, SARS-CoV-2 would infect humans via
      binding of S-protein to angiotensin-converting enzyme 2 (ACE2), a host cell receptor, and the
      S protein is activated and cleaved by cellular transmembrane serine proteases, allowing the
      virus to release fusion peptides for membrane fusion. In addition to the lungs, ACE2 is also
      highly expressed in the esophagus, small intestine and colon, suggesting that the gut might
      also be an important target organ for SARS-CoV-2. About 8-16% of severe pneumonia cases
      confirmed with SARS-CoV-2 infection developed gastrointestinal symptoms such as abdominal
      pain, vomiting, and diarrhea. Moreover, the stool of patient with COVID-19 also positive by
      real-time reverse-transcriptase-polymerase-chain-reaction (rRT-PCR) assay. Furthermore,
      elevated faecal calprotectin was observed in patients with COVID-19 suggested an inflammatory
      response in the gut, which was significantly correlated with IL-6. For severe and critical
      cases, control "cytokine storms" and maintain intestinal microenvironment balance have been
      included into the Diagnosis and Treatment Guideline of patients with COVID-19 (Edition 7).
      Berberine is a quaternary ammonium alkaloid isolated from rhizoma coptidis. It is often used
      in treatment of infectious diarrhea by bacteriostasis and inhibition of intestinal gland
      secretion. Berberine has also been found to have a role in intestinal immune regulation,
      inhibiting both AP-1 and NF- B, the key factors in cell signal transduction, and reducing the
      inflammatory response. Investigators conducted a prospective randomized controlled clinical
      trial to investigate the effects of berberine on intestinal function, serum concentrations of
      the inflammatory biomarkers, and organ function in severe patients with SARS-CoV-2 infection.
Patients aged 18-80 years who confirmed with COVID-19 and classified as severe were enrolled
      in the study, and then separated randomly into two groups: a berberine group (B group) and a
      control group (C group). The diagnostic criteria for severe cases are in accordance with the
      Diagnosis and Treatment Guideline of patients with COVID-19 issued by the National Health
      Commission of the People's Republic of China (Edition 7). In general, patients diagnosed with
      COVID-19 pneumonia must also meet any of the following criteria: appears shortness of breath,
      respiratory rate (RR) ≥ 30 times/min; SPO2 ≤ 93% at rest; the ratio of partial oxygen
      pressure of arterial blood (PaO2) to oxygen absorption concentration (FiO2) ≤ 300mmHg
      (1mmHg=0.133KPa); pulmonary imaging showed the lesion progression >50% within 24-48 hours.
      All enrolled patients were given general support therapy, oxygen therapy, antiviral drugs, in
      combination with antibiotics and small doses of glucocorticoids if necessary, nutritional and
      organ function support. Patients in the berberine group (B group) were given berberine 0.3g
      tid orally or tube feed daily, while patients in the control group (C group) were given
      montmorilonite orally if they presence of diarrhea. The duration of the study intervention
      was 14 days and followed up to discharge. Investigators record general information about
      patients at admission, including age, gender, age, exposure history, time from onset of
      symptoms to hospital, APACHE II score, the presentation of X-ray, comorbidity, mechanical
      ventilation, fever or not,gastrointestinal symptoms. Investigators also evaluate the
      gastrointestinal function daily,including gastrointestinal symptoms (nausea, vomiting,
      abdominal pain, abdominal distension or diarrhoea), frequency of diarrhea, the
      characteristics of stool (Bristol scal). Peripheral blood are collected on day 1,3, 7 and 14
      after admission to determine the level of interleukin-6 (IL-6), interleukin-1β (IL-1β),
      interleukin-10 (IL-10) and tumor necrosis factor (TNF-α). Laboratory tests are also performed
      to evaluate leucocyte, c-reactive protein (CRP), and procalcitonin (PCT) levels at the same
      time. Glutamate transaminase (ALT), glutamate transaminase (AST), urea nitrogen (Bun),
      creatinine, prothrombin time (PT), partially activated prothrombin time (APTT), and
      Sequential Organ Failure Assessment (SOFA) score are used to evaluate organ function on day
      1,3, 7 and 14 after admission. Investigators also record the adverse events associated with
      the drug, length of stay and the prognosis at discharge. The patients are blinded to the
      group allocation. Two physicians are responsible for data processing, one is responsible for
      recording and collecting, and the other is responsible for checking, and they are all blind
      to the research.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Changes in diarrhea frequency and Bristol Stool Scale
time frame: daily, from date of randomization until the date of discharge or date of death from any cause, assessed up to 2 weeks.
description: Including diarrhea in times/day, Bristol Stool Scale (the minimum 1 and maximum 7, a higher scores mean a worse outcome) and whether patient has any one of gastrointestinal symptoms (nausea, vomiting, abdominal pain, abdominal distension or diarrhoea).
measure: IL-6 (ng/ml)
time frame: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
description: evaluate inflammatory response, blood sample collected at 6:00am
measure: IL-10（ng/ml）
time frame: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
description: evaluate inflammatory response, blood sample collected at 6:00am
measure: IL-1β (ng/ml)
time frame: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
description: evaluate inflammatory response, blood sample collected at 6:00am
measure: TNF-α (pg/ml)
time frame: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
description: evaluate inflammatory response, blood sample collected at 6:00am
measure: leukocyte count (10^9/l)
time frame: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
description: evaluate inflammatory response, blood sample collected at 6:00am
measure: c reactive protein (mg/l)
time frame: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
description: evaluate inflammatory response, blood sample collected at 6:00am
measure: procalcitonin (ng/ml)
time frame: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause
description: evaluate inflammatory response, blood sample collected at 6:00am
measure: Sequential Organ Failure Assessment (SOFA) score
time frame: baseline (at admission), day 3, 7 and 14 after admission or until the date of discharge or date of death from any cause
description: evaluate the severity of the disease(the minimum 0 and maximum 24, a higher scores mean a worse outcome)
arm group label: berberine group (B group)
arm group type: Experimental
description: Patients in the B group were given berberine hydrochloride tables 0.3g tid orally or tube feed daily, until the 14th day of the study. Other treatments include general support therapy, oxygen therapy, antiviral drugs, in combination with antibiotics and small doses of glucocorticoids if necessary, nutritional and organ function support.
arm group label: control group (C group)
arm group type: Sham Comparator
description: Patients in the C group were given montmorilonite orally if they presence of diarrhea. The other treatments were the same as in B group.
intervention type: Drug
intervention name: Berberine
description: Patients in the intervention group received berberine daily, regardless of gastrointestinal symptoms.If the patient has a serious drug-related adverse event, the drug will be discontinued and the patient will be excluded from the study.
arm group label: berberine group (B group)
other name: Berberine Hydrochloride Tablets
intervention type: Drug
intervention name: Montmorrillonite
description: Patients in the control group were routinely not given special treatment.However, if the patient has diarrhea symptoms, montmorillonite powder should be given orally.
arm group label: control group (C group)
other name: Montmorrillonite Powder
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Wenkui Yu, M.D.
role: Study Chair
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
facility: 
country: China
citation: Effenberger M, Grabherr F, Mayr L, Schwaerzler J, Nairz M, Seifert M, Hilbe R, Seiwald S, Scholl-Buergi S, Fritsche G, Bellmann-Weiler R, Weiss G, Muller T, Adolph TE, Tilg H. Faecal calprotectin indicates intestinal inflammation in COVID-19. Gut. 2020 Aug;69(8):1543-1544. doi: 10.1136/gutjnl-2020-321388. Epub 2020 Apr 20. No abstract available.
PMID: 32312790
citation: Jin X, Lian JS, Hu JH, Gao J, Zheng L, Zhang YM, Hao SR, Jia HY, Cai H, Zhang XL, Yu GD, Xu KJ, Wang XY, Gu JQ, Zhang SY, Ye CY, Jin CL, Lu YF, Yu X, Yu XP, Huang JR, Xu KL, Ni Q, Yu CB, Zhu B, Li YT, Liu J, Zhao H, Zhang X, Yu L, Guo YZ, Su JW, Tao JJ, Lang GJ, Wu XX, Wu WR, Qv TT, Xiang DR, Yi P, Shi D, Chen Y, Ren Y, Qiu YQ, Li LJ, Sheng J, Yang Y. Epidemiological, clinical and virological characteristics of 74 cases of coronavirus-infected disease 2019 (COVID-19) with gastrointestinal symptoms. Gut. 2020 Jun;69(6):1002-1009. doi: 10.1136/gutjnl-2020-320926. Epub 2020 Mar 24.
PMID: 32213556
citation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
PMID: 32171076
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Bentonite
sharing ipd: No
ipd description: We have other articles about covid-19 yet to be published