<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/NCT03019042</url>
  </required_header>
  <id_info>
    <org_study_id>JXUTCM-EBM-01</org_study_id>
    <nct_id>NCT03019042</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Non-organic Gastrointestinal Disorders</brief_title>
  <official_title>Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Non-organic Gastrointestinal Disorders: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangxi University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nanchang Hongdu Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanchang Hospital of Integrated Traditional Chinese and Western Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Nanchang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital of Nanchang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jiangxi University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial aims to determine whether Hou Gu Mi Xi is an effective treatment for improving&#xD;
      symptoms and indicators in patients with spleen qi deficiency and mild gastrointestinal&#xD;
      disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic gastrointestinal disorders are one of major health problems around the globe. The&#xD;
      annual number of patients with chronic gastrointestinal disorders was about 60 to 70 million&#xD;
      in American. According to the American statistics in 2014, 4.6 million admissions and 230&#xD;
      thousand patients died due to chronic gastrointestinal disorders. The direct or indirect&#xD;
      costs caused by chronic gastrointestinal disorders reached at 142 billion dollars. In China,&#xD;
      the incidence of chronic gastrointestinal disorders is 7.3‰ among urban residents, which&#xD;
      ranks No. 5 among all diseases and leads to 975 dollars of annually medical costs for per&#xD;
      patient.&#xD;
&#xD;
      Along with the development of medical science, traditional Chinese medicine (TCM) is playing&#xD;
      an increasingly rule in treatment of chronic gastrointestinal disorders, especially for these&#xD;
      mild gastrointestinal disorders which are hard to obtain efficacy in western medicine. Shen&#xD;
      Ling Bai Zhu San, a classic Chinese medicinal formulae originally described in Tai Ping Hui&#xD;
      Min He Ji Ju Fang in the Fang Song Dynasty (1102 AD), is composed of ginseng, tuckahoe,&#xD;
      atractylodes, baked licorice, coixenolide, Chinese yam, lotus seed, shrinkage fructus amomi,&#xD;
      platycodon grandiflorum, white hyacinth bean, and dried orange peel. It has effects of&#xD;
      replenishing qi and invigorating spleen (spleen is a TCM conception different from western&#xD;
      medicine), as well as penetrating wet and antidiarrheal. It is mainly used for treating the&#xD;
      syndrome of spleen qi deficiency, including dyspepsia, chest and stomach distress,&#xD;
      borborygmus and diarrhea, limb weakness, thin body, sallow complexion, pale tongue with white&#xD;
      and greasy coating, and weak and slow pulse, etc. In the theory of TCM, spleen is the source&#xD;
      for producing qi and blood and thus is the root of life. Shen Ling Bai Zhu San could&#xD;
      invigorate spleen by supplying spleen and remove wet, and finally nourish the stomach and&#xD;
      intestine.&#xD;
&#xD;
      To date, Shen Ling Bai Zhu San is mainly used to treat mild gastrointestinal disorder like&#xD;
      irritable bowel syndrome and functional dyspepsia in patients with a TCM syndrome of spleen&#xD;
      qi deficiency. Pharmacologic study revealed that Shen Ling Bai Zhu San could adjust function&#xD;
      of anaerobic and aerobic bacteria in gastrointestinal tract; specifically, it could improve&#xD;
      the proliferation of probiotics (such as bifidobacterium) and inhibit the main resistance&#xD;
      strains (such as enterococcus) and thus has an effect to improve gastrointestinal symptoms.&#xD;
&#xD;
      Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, of which removes&#xD;
      atractylodes and platycodon grandiflorum (two herbs that could not be used as food) from Shen&#xD;
      Ling Bai Zhu San, and adds perilla leaf for adapting a dietary therapy. Hou Gu Mi Xi used the&#xD;
      main formula of Shen Ling Bai Zhu San, so that it could theoretically maintain the treatment&#xD;
      effects. Although the reliable health effects of Shen Ling Bai Zhu San has been proved in&#xD;
      previous studies, Hou Gu Mi Xi is optimized in formula and its preparations changed from&#xD;
      electuary to rice paste, so that its functional mechanism and efficacy may also be different.&#xD;
      Therefore, the investigators plan to perform a hospital-based randomized controlled trial,&#xD;
      enroll patients from five hospitals in Nanchang City of Jiangxi Province in China, for&#xD;
      assessing efficacy and safety of Hou Gu Mi Xi on Gastrointestinal symptoms and indicators in&#xD;
      Patients with Spleen Qi Deficiency and Mild Gastrointestinal Disorder.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2016</start_date>
  <completion_date type="Actual">July 10, 2019</completion_date>
  <primary_completion_date type="Actual">July 10, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in total scores of Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (Units on a scale)</measure>
    <time_frame>At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks</time_frame>
    <description>Higher score indicates severer symptoms of Spleen Qi Deficiency. Units of measure (Units on a scale)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Gastrin-17 (ng/L)</measure>
    <time_frame>At baseline and 52 and 104 weeks</time_frame>
    <description>To determine whether the interventions improve gastric function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative results of gastroscopy</measure>
    <time_frame>At baseline and 104 weeks</time_frame>
    <description>To assess pathologic changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in body weight (kg)</measure>
    <time_frame>At baseline and 52 and 104 weeks</time_frame>
    <description>To determine whether the interventions improve body weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in body mass index (kg/m2)</measure>
    <time_frame>At baseline and 52 and 104 weeks</time_frame>
    <description>To determine whether the interventions improve body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of any adverse events</measure>
    <time_frame>From the first dose of intervention up to 104 weeks</time_frame>
    <description>Assessing by abnormal results (indicated by more or less than 2 × normal reference interval) in the routine blood, urine, and stool tests, liver function tests (alanine transaminase [ALT], aspartate aminotransferase [AST], total bilirubin [TBIL], direct bilirubin [DBIL], indirect bilirubin [IBIL]), kidney function tests (serum creatinine [SCr] and urea nitrogen [BUN]), and electrocardiogram as well as doctor-evaluated and patient-reported adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of severe adverse events</measure>
    <time_frame>From the first dose of intervention up to 104 weeks</time_frame>
    <description>AEs that lead to new or prolonged hospitalization, disability, admission to intensive care unit, life danger, and death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of drug-related adverse events</measure>
    <time_frame>From the first dose of intervention up to 104 weeks</time_frame>
    <description>This outcome is assessed by blinded clinicians in each research center</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of withdrawn due to adverse events</measure>
    <time_frame>From the first dose of intervention up to 104 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Gastrointestinal Disease</condition>
  <arm_group>
    <arm_group_label>Hou Gu Mi Xi</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm receive Hou Gu Mi Xi, with oral dose of 30 g/day (contain 10.1 herb materials) during entire follow up period (2 years). HGMX is composed of 10 dietary Chinese herbs (including ginseng (Renshen), tuckahoe (Fuling), coixenolide (Yiyiren), Chinese yam (Shanyao), lotus seed (Lianzi), amomum (Sharen), platycodon (Jiegen), white hyacinth bean (Baibiandou), licorice (Gancao), and orange peel (Jupi)), early rice, and oats.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients in this arm receive placebo, with oral dose of 30 g/day during entire follow up period (2 years). The placebo is only consist of early rice and oats.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Hou Gu Mi Xi</intervention_name>
    <description>Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, of which removes atractylodes and platycodon grandiflorum, adds perilla leaf for adapting a dietary therapy.</description>
    <arm_group_label>Hou Gu Mi Xi</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>The placebo has same appearance, taste and smell as Hou Gu Mi Xi.</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient should have mild gastrointestinal disorder without any organic pathologic&#xD;
             changes (see exclusion criteria) by diagnosis of gastroscopy within 6 months, which&#xD;
             mainly include chronic non-atrophic gastritis, functional gastrointestinal disorders,&#xD;
             irritable bowel syndrome, and functional dyspepsia&#xD;
&#xD;
          -  Patient should be status of spleen qi deficiency, that is, meet 2 main symptoms of&#xD;
             spleen deficiency and 2 main symptoms of qi deficiency, or have 2 main symptoms of&#xD;
             spleen deficiency, 1 main symptoms of qi deficiency and 1 tongue symptom, or have 1&#xD;
             main symptom of spleen deficiency + 1 main symptom of qi deficiency + 2 secondary&#xD;
             symptom + 1 tongue symptom as follow:&#xD;
&#xD;
               1. Main symptoms of spleen deficiency: a) poor appetite; b) abnormal stool (loose,&#xD;
                  diarrhea); c) abdominal distention after meal or afternoon&#xD;
&#xD;
               2. Main symptoms of qi deficiency: a) fatigue; b) tired mind and taciturnity&#xD;
&#xD;
               3. Secondary symptoms: a) tastelessness, hypodipsia, like hot drink, or polysialia;&#xD;
                  b) abdominal pain, as a result either patients like warm or press, or remit after&#xD;
                  meal, or occur when work; c) nausea and vomiting; d) fullness in stomach; e)&#xD;
                  abnormal bowel sounds; f) lean or puffiness; g) sallow complexion; h) powerless&#xD;
                  defecation weakness; i) edema&#xD;
&#xD;
               4. Tongue symptoms: pale or swollen or teeth-printed tongue with thin and white fur&#xD;
&#xD;
          -  Fourteen years old or more&#xD;
&#xD;
          -  Sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have organic pathologic changes, including peptic ulcer, gastrointestinal&#xD;
             erosions, gastroesophageal reflux disease, acute gastrointestinal hemorrhage or&#xD;
             perforation, structural changes in gastrointestinal structure, gastrointestinal&#xD;
             vascular diseases, ileus, and benign tumor&#xD;
&#xD;
          -  Pregnancy or breast-feeding women&#xD;
&#xD;
          -  Allergic to sample or sample composition&#xD;
&#xD;
          -  impaired liver function, including one of following condition: a) total bilirubin &gt; 2&#xD;
             upper limit of normal (ULN); b) alanine transaminase &gt;2 ULN; or c) aspartate&#xD;
             aminotransferase &gt;2 ULN&#xD;
&#xD;
          -  impaired kidney function, that is, serum creatinine &gt;2 ULN&#xD;
&#xD;
          -  obviously abnormal electrocardiogram&#xD;
&#xD;
          -  patients who undertaken drugs that could cause damage in stomach and intestine, or&#xD;
             patients experience side effects of dyspepsia as undertaking non-steroidal&#xD;
             anti-inflammatory drugs, theophylline, oral antibiotic or potassium supplements within&#xD;
             3 months&#xD;
&#xD;
          -  patients who are receiving any agents or other intervention for treating his/her&#xD;
             gastrointestinal disorder&#xD;
&#xD;
          -  patients with any malignant tumor&#xD;
&#xD;
          -  patients who have severe mental disorders so that could not control his/her action and&#xD;
             coordinate the treatment in this trial.&#xD;
&#xD;
          -  patients who are unwilling to provider personal information and enter this trial&#xD;
&#xD;
          -  patients who cannot understand and sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weifeng Zhu, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Jiangxi University of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jiangxi University of Traditional Chinese Medicine</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Everhart JE, Ruhl CE. Burden of digestive diseases in the United States part I: overall and upper gastrointestinal diseases. Gastroenterology. 2009 Feb;136(2):376-86. doi: 10.1053/j.gastro.2008.12.015. Epub 2009 Jan 3. No abstract available.</citation>
    <PMID>19124023</PMID>
  </reference>
  <reference>
    <citation>Farthing M, Roberts SE, Samuel DG, Williams JG, Thorne K, Morrison-Rees S, John A, Akbari A, Williams JC. Survey of digestive health across Europe: Final report. Part 1: The burden of gastrointestinal diseases and the organisation and delivery of gastroenterology services across Europe. United European Gastroenterol J. 2014 Dec;2(6):539-43. doi: 10.1177/2050640614554154. No abstract available.</citation>
    <PMID>25452850</PMID>
  </reference>
  <reference>
    <citation>Wu TH, Chen IC, Chen LC. Antacid effects of Chinese herbal prescriptions assessed by a modified artificial stomach model. World J Gastroenterol. 2010 Sep 21;16(35):4455-9. doi: 10.3748/wjg.v16.i35.4455.</citation>
    <PMID>20845514</PMID>
  </reference>
  <reference>
    <citation>Yin GY, Chen Y, Shen XJ, He XF, Zhang WN. Study on the pathophysiologic basis of classification of 'spleen' deficiency in chronic gastritis. Chin Med J (Engl). 2005 Mar 20;118(6):468-73.</citation>
    <PMID>15788127</PMID>
  </reference>
  <reference>
    <citation>Yin GY, Zhang WN, Shen XJ, He XF, Chen Y. Study on the pathological basis of classification of spleen deficiency in chronic gastritis. Chin Med J (Engl). 2004 Aug;117(8):1246-52.</citation>
    <PMID>15361303</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 7, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>May 7, 2020</last_update_submitted>
  <last_update_submitted_qc>May 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jiangxi University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Xu Zhou</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>Hou Gu Mi Xi</keyword>
  <keyword>Shen Ling Bai Zhu San</keyword>
  <keyword>mild gastrointestinal disorders</keyword>
  <keyword>traditional Chinese medicine</keyword>
  <keyword>randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The individual participant data are not planned to share.</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/NCT03019042
org study id: JXUTCM-EBM-01
nct id: NCT03019042
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This trial aims to determine whether Hou Gu Mi Xi is an effective treatment for improving
      symptoms and indicators in patients with spleen qi deficiency and mild gastrointestinal
      disorder.
Chronic gastrointestinal disorders are one of major health problems around the globe. The
      annual number of patients with chronic gastrointestinal disorders was about 60 to 70 million
      in American. According to the American statistics in 2014, 4.6 million admissions and 230
      thousand patients died due to chronic gastrointestinal disorders. The direct or indirect
      costs caused by chronic gastrointestinal disorders reached at 142 billion dollars. In China,
      the incidence of chronic gastrointestinal disorders is 7.3‰ among urban residents, which
      ranks No. 5 among all diseases and leads to 975 dollars of annually medical costs for per
      patient.

      Along with the development of medical science, traditional Chinese medicine (TCM) is playing
      an increasingly rule in treatment of chronic gastrointestinal disorders, especially for these
      mild gastrointestinal disorders which are hard to obtain efficacy in western medicine. Shen
      Ling Bai Zhu San, a classic Chinese medicinal formulae originally described in Tai Ping Hui
      Min He Ji Ju Fang in the Fang Song Dynasty (1102 AD), is composed of ginseng, tuckahoe,
      atractylodes, baked licorice, coixenolide, Chinese yam, lotus seed, shrinkage fructus amomi,
      platycodon grandiflorum, white hyacinth bean, and dried orange peel. It has effects of
      replenishing qi and invigorating spleen (spleen is a TCM conception different from western
      medicine), as well as penetrating wet and antidiarrheal. It is mainly used for treating the
      syndrome of spleen qi deficiency, including dyspepsia, chest and stomach distress,
      borborygmus and diarrhea, limb weakness, thin body, sallow complexion, pale tongue with white
      and greasy coating, and weak and slow pulse, etc. In the theory of TCM, spleen is the source
      for producing qi and blood and thus is the root of life. Shen Ling Bai Zhu San could
      invigorate spleen by supplying spleen and remove wet, and finally nourish the stomach and
      intestine.

      To date, Shen Ling Bai Zhu San is mainly used to treat mild gastrointestinal disorder like
      irritable bowel syndrome and functional dyspepsia in patients with a TCM syndrome of spleen
      qi deficiency. Pharmacologic study revealed that Shen Ling Bai Zhu San could adjust function
      of anaerobic and aerobic bacteria in gastrointestinal tract; specifically, it could improve
      the proliferation of probiotics (such as bifidobacterium) and inhibit the main resistance
      strains (such as enterococcus) and thus has an effect to improve gastrointestinal symptoms.

      Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, of which removes
      atractylodes and platycodon grandiflorum (two herbs that could not be used as food) from Shen
      Ling Bai Zhu San, and adds perilla leaf for adapting a dietary therapy. Hou Gu Mi Xi used the
      main formula of Shen Ling Bai Zhu San, so that it could theoretically maintain the treatment
      effects. Although the reliable health effects of Shen Ling Bai Zhu San has been proved in
      previous studies, Hou Gu Mi Xi is optimized in formula and its preparations changed from
      electuary to rice paste, so that its functional mechanism and efficacy may also be different.
      Therefore, the investigators plan to perform a hospital-based randomized controlled trial,
      enroll patients from five hospitals in Nanchang City of Jiangxi Province in China, for
      assessing efficacy and safety of Hou Gu Mi Xi on Gastrointestinal symptoms and indicators in
      Patients with Spleen Qi Deficiency and Mild Gastrointestinal Disorder.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in total scores of Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (Units on a scale)
time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
description: Higher score indicates severer symptoms of Spleen Qi Deficiency. Units of measure (Units on a scale)
measure: Change from baseline in Gastrin-17 (ng/L)
time frame: At baseline and 52 and 104 weeks
description: To determine whether the interventions improve gastric function
measure: Quantitative results of gastroscopy
time frame: At baseline and 104 weeks
description: To assess pathologic changes
measure: Changes from baseline in body weight (kg)
time frame: At baseline and 52 and 104 weeks
description: To determine whether the interventions improve body weight
measure: Changes from baseline in body mass index (kg/m2)
time frame: At baseline and 52 and 104 weeks
description: To determine whether the interventions improve body mass index
measure: Incidence of any adverse events
time frame: From the first dose of intervention up to 104 weeks
description: Assessing by abnormal results (indicated by more or less than 2 × normal reference interval) in the routine blood, urine, and stool tests, liver function tests (alanine transaminase [ALT], aspartate aminotransferase [AST], total bilirubin [TBIL], direct bilirubin [DBIL], indirect bilirubin [IBIL]), kidney function tests (serum creatinine [SCr] and urea nitrogen [BUN]), and electrocardiogram as well as doctor-evaluated and patient-reported adverse events
measure: Incidence of severe adverse events
time frame: From the first dose of intervention up to 104 weeks
description: AEs that lead to new or prolonged hospitalization, disability, admission to intensive care unit, life danger, and death
measure: Incidence of drug-related adverse events
time frame: From the first dose of intervention up to 104 weeks
description: This outcome is assessed by blinded clinicians in each research center
measure: Incidence of withdrawn due to adverse events
time frame: From the first dose of intervention up to 104 weeks
arm group label: Hou Gu Mi Xi
arm group type: Experimental
description: Patients in this arm receive Hou Gu Mi Xi, with oral dose of 30 g/day (contain 10.1 herb materials) during entire follow up period (2 years). HGMX is composed of 10 dietary Chinese herbs (including ginseng (Renshen), tuckahoe (Fuling), coixenolide (Yiyiren), Chinese yam (Shanyao), lotus seed (Lianzi), amomum (Sharen), platycodon (Jiegen), white hyacinth bean (Baibiandou), licorice (Gancao), and orange peel (Jupi)), early rice, and oats.
arm group label: placebo
arm group type: Placebo Comparator
description: Patients in this arm receive placebo, with oral dose of 30 g/day during entire follow up period (2 years). The placebo is only consist of early rice and oats.
intervention type: Dietary Supplement
intervention name: Hou Gu Mi Xi
description: Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, of which removes atractylodes and platycodon grandiflorum, adds perilla leaf for adapting a dietary therapy.
arm group label: Hou Gu Mi Xi
intervention type: Other
intervention name: placebo
description: The placebo has same appearance, taste and smell as Hou Gu Mi Xi.
arm group label: placebo
criteria: 
gender: All
minimum age: 14 Years
maximum age: 120 Years
healthy volunteers: No
last name: Weifeng Zhu, Ph.D.
role: Study Chair
affiliation: Jiangxi University of Traditional Chinese Medicine
facility: 
country: China
citation: Everhart JE, Ruhl CE. Burden of digestive diseases in the United States part I: overall and upper gastrointestinal diseases. Gastroenterology. 2009 Feb;136(2):376-86. doi: 10.1053/j.gastro.2008.12.015. Epub 2009 Jan 3. No abstract available.
PMID: 19124023
citation: Farthing M, Roberts SE, Samuel DG, Williams JG, Thorne K, Morrison-Rees S, John A, Akbari A, Williams JC. Survey of digestive health across Europe: Final report. Part 1: The burden of gastrointestinal diseases and the organisation and delivery of gastroenterology services across Europe. United European Gastroenterol J. 2014 Dec;2(6):539-43. doi: 10.1177/2050640614554154. No abstract available.
PMID: 25452850
citation: Wu TH, Chen IC, Chen LC. Antacid effects of Chinese herbal prescriptions assessed by a modified artificial stomach model. World J Gastroenterol. 2010 Sep 21;16(35):4455-9. doi: 10.3748/wjg.v16.i35.4455.
PMID: 20845514
citation: Yin GY, Chen Y, Shen XJ, He XF, Zhang WN. Study on the pathophysiologic basis of classification of 'spleen' deficiency in chronic gastritis. Chin Med J (Engl). 2005 Mar 20;118(6):468-73.
PMID: 15788127
citation: Yin GY, Zhang WN, Shen XJ, He XF, Chen Y. Study on the pathological basis of classification of spleen deficiency in chronic gastritis. Chin Med J (Engl). 2004 Aug;117(8):1246-52.
PMID: 15361303
responsible party type: Principal Investigator
investigator affiliation: Jiangxi University of Traditional Chinese Medicine
investigator full name: Xu Zhou
investigator title: Lecturer
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases
sharing ipd: No
ipd description: The individual participant data are not planned to share.