<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/NCT03025152</url>
  </required_header>
  <id_info>
    <org_study_id>JXUTCM-EBM-02</org_study_id>
    <nct_id>NCT03025152</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Radical Gastrectomy for Gastric Cancer</brief_title>
  <official_title>Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Radical Gastrectomy for Gastric Cancer: A Multicenter, Randomized, Double-blinded, 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>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>Jiangxi Provincial Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jiangxi University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</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>
      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 radical gastrectomy for&#xD;
      gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The incidence of gastric cancer ranks high in many countries around the world. Although along&#xD;
      with the development of economy and medical condition the incidence of gastric cancer appears&#xD;
      a trend of decrease in developed countries, it is still one of most common cancers in Asia.&#xD;
      There are more new gastric cancer cases in China compared with other countries every year.&#xD;
      According to an epidemiological survey by World Health Organization, 5-year prevalence of&#xD;
      gastric cancer was 53.7/10,000 in China - it is only lower than Japan. For the early gastric&#xD;
      cancer, radical gastrectomy, is the most important treatment, which could significantly&#xD;
      prolong disease-free survival and overall survival. However, the severe damage of surgery and&#xD;
      following radiation and chemotherapy in intestinal tract usually leads patients to be a&#xD;
      constitution of spleen qi deficiency, a concept of traditional Chinese medicine (TCM) that&#xD;
      mainly involves digestive symptoms, such as poor appetite, abnormal stool (loose, diarrhea)&#xD;
      and abdominal distention. Therefore, how to resolve and protect the function of intestinal&#xD;
      tract, and change the constitution of spleen qi deficiency postoperatively is important for&#xD;
      improving quality of life and reducing the recurrence rate of cancer.&#xD;
&#xD;
      Shen Ling Bai Zhu San, a classic Chinese medicinal formulae originally described in Tai Ping&#xD;
      Hui Min He Ji Ju Fang in the 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 that differs 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. Previous pharmacologic studies also revealed that Shen Ling Bai Zhu San could&#xD;
      adjust function of anaerobic and aerobic bacteria in gastrointestinal tract; specifically, it&#xD;
      could improve the proliferation of probiotics (such as bifidobacterium) and inhibit the main&#xD;
      resistance strains (such as enterococcus) and thus has an effect to improve gastrointestinal&#xD;
      symptoms.&#xD;
&#xD;
      According to the experience of TCM, the constitution of patients who are undergoing radiation&#xD;
      and chemotherapy is usually yin deficiency, but changes to spleen qi deficiency due to&#xD;
      digestive disorders after those treatment. Therefore, Shen Ling Bai Zhu San is expected to&#xD;
      improve symptoms in patients who underwent gastrectomy and following radiation and&#xD;
      chemotherapy.&#xD;
&#xD;
      Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, which removes atractylodes&#xD;
      and platycodon grandiflorum (two herbs that could not be used as food) from Shen Ling Bai Zhu&#xD;
      San, and adds perilla leaf for adapting a dietary therapy for a long-term use. Hou Gu Mi Xi&#xD;
      uses the main formula of Shen Ling Bai Zhu San, so that it could theoretically maintain the&#xD;
      treatment effects. Although the reliable health effects of Shen Ling Bai Zhu San has been&#xD;
      proved in previous studies, Hou Gu Mi Xi is optimized in formula and its preparations changed&#xD;
      from electuary to rice paste, so that its functional mechanism and efficacy may be different.&#xD;
      Therefore, the investigators plan to perform a hospital-based randomized controlled trial,&#xD;
      enroll patients from three hospitals in Nanchang City of Jiangxi Province in China, for&#xD;
      assessing efficacy and safety of Hou Gu Mi Xi on digestive symptoms in patients with spleen&#xD;
      qi deficiency and radical gastrectomy for gastric cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    High attrition rate up to 37.7% at one year's follow-up&#xD;
  </why_stopped>
  <start_date type="Actual">November 11, 2016</start_date>
  <completion_date type="Actual">July 20, 2019</completion_date>
  <primary_completion_date type="Actual">July 20, 2019</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>Changes 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>Qualitative assessment of changes in total scores of SQD scale from baseline</measure>
    <time_frame>At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks</time_frame>
    <description>1) completely remission: reduction in scores is ≥ 95% compared with baseline; 2) markedly effective: reduction in scores is 70% to 94% compared with baseline; 3) effective: reduction in scores is 30% to 69% compared with baseline; 4) not effective: reduction in scores is &lt; 30% compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in scores of each item of SQD scale from baseline</measure>
    <time_frame>At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks</time_frame>
    <description>1) Stomach distension*, 2) Abdominal distension*, 3) Fatigue and weakness*, 4) Tired mind and taciturnity*, 5) Inappetence*, 6) Stomach pain, 7) Stomach tightness, 8) Abdominal pain, 9) Acid reflux, 10) Belching, 11) Nausea and vomiting, 12) Abnormal stools, 13) Abnormal bowel sounds, 14) Powerless defecation, 15) Sallow complexion, 16) Tastelessness and hypodipsia, and 17) Face and limbs edema.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in total scores of Short Form 36 (SF-36) (Units on a scale)</measure>
    <time_frame>At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks</time_frame>
    <description>To assess quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in scores of subitems in Short Form 36 (SF-36) (Units on a scale)</measure>
    <time_frame>At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks</time_frame>
    <description>Physical Component Summary (PCS) and Mental Component Summary (MCS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in scores of Eastern Cooperative Oncology Group (ECOG) Performance Status (Units on a scale)</measure>
    <time_frame>At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks</time_frame>
    <description>To assess performance status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (month)</measure>
    <time_frame>From the first dose of intervention up to 104 weeks</time_frame>
    <description>assessed by evidence of pathological examination, computed tomography and/or magnetic resonance imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in systolic blood pressure (mmHg)</measure>
    <time_frame>At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks</time_frame>
    <description>To determine whether the interventions improve systolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in diastolic blood pressure (mmHg)</measure>
    <time_frame>At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks</time_frame>
    <description>To determine whether the interventions improve diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in body weight (kg)</measure>
    <time_frame>At baseline and 2, 4, 8, 26, 52, 78 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 2, 4, 8, 26, 52, 78 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>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]), coagulation function (prothrombin time [PT], activated partial thromboplastin time [APTT], thrombin time [TT], fibrinogen [FIB]), and electrocardiogram as well as any other new-onset symptoms or diseases related or unrelated to the intervention</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">130</enrollment>
  <condition>Gastric Cancer</condition>
  <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 an oral dose of 10 g/day during entire follow up period (2 years).</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 an oral dose of 10 g/day during entire follow up period (2 years).</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, 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 be diagnosed as gastric cancer by pathology and have received radical&#xD;
             gastrectomy. They should finish the following radiotherapy and chemotherapy and the&#xD;
             treatment for surgical complications (such as leak, stricture, and marginal ulcer).&#xD;
&#xD;
          -  Patient should be constitution of spleen qi deficiency, that is, meet two primary&#xD;
             symptoms of spleen deficiency + two primary symptoms of qi deficiency, or meet two&#xD;
             primary symptoms of spleen deficiency + one primary symptoms of qi deficiency + one&#xD;
             auxiliary symptoms, or meet one primary symptoms of spleen deficiency + one primary&#xD;
             symptoms of qi deficiency + two secondary symptoms + one auxiliary symptoms 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, polysialia; b)&#xD;
                  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. Auxiliary symptoms: pale or swollen or teeth-printed tongue with thin and white&#xD;
                  fur&#xD;
&#xD;
          -  Age ranges from 18 to 70 years; both male and female&#xD;
&#xD;
          -  Patient should be in fair performance status, indicated by a score of Eastern&#xD;
             Cooperative Oncology Group (ECOG) Performance Status ≤ 1&#xD;
&#xD;
          -  Sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stage IV gastric cancer according to the Japanese classification criteria [16]&#xD;
&#xD;
          -  Impaired liver function (total bilirubin &gt; 2 × upper limit of normal (ULN), alanine&#xD;
             transaminase &gt; 2 × ULN, or aspartate aminotransferase &gt; 2 × ULN), kidney function&#xD;
             (serum creatinine &gt; 2 × ULN), or hematopoiesis (neutrophil counts &lt; 0.5×109/L or,&#xD;
             thrombocyte counts &lt; 20×109/L or, absolute reticulocyte counts &lt; 15×109/L)&#xD;
&#xD;
          -  Obviously abnormal electrocardiogram&#xD;
&#xD;
          -  Severe mental disorders&#xD;
&#xD;
          -  Other severe diseases (e.g. multiple organ failure, HIV infection)&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Allergic to the test sample&#xD;
&#xD;
          -  Unwilling to provider personal information and sign the informed consent&#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_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>Oh SY, Lee HJ, Yang HK. Pylorus-Preserving Gastrectomy for Gastric Cancer. J Gastric Cancer. 2016 Jun;16(2):63-71. doi: 10.5230/jgc.2016.16.2.63. Epub 2016 Jun 24.</citation>
    <PMID>27433390</PMID>
  </reference>
  <reference>
    <citation>Yang L. Incidence and mortality of gastric cancer in China. World J Gastroenterol. 2006 Jan 7;12(1):17-20. doi: 10.3748/wjg.v12.i1.17.</citation>
    <PMID>16440411</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>April 2021</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>April 22, 2021</last_update_submitted>
  <last_update_submitted_qc>April 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2021</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>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hou Gu Mi Xi</keyword>
  <keyword>Shen Ling Bai Zhu San</keyword>
  <keyword>radical gastrectomy</keyword>
  <keyword>gastric cancer</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>Stomach Neoplasms</mesh_term>
    <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 investigators do not plan to share individual participant data.</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/NCT03025152
org study id: JXUTCM-EBM-02
nct id: NCT03025152
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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 radical gastrectomy for
      gastric cancer.
The incidence of gastric cancer ranks high in many countries around the world. Although along
      with the development of economy and medical condition the incidence of gastric cancer appears
      a trend of decrease in developed countries, it is still one of most common cancers in Asia.
      There are more new gastric cancer cases in China compared with other countries every year.
      According to an epidemiological survey by World Health Organization, 5-year prevalence of
      gastric cancer was 53.7/10,000 in China - it is only lower than Japan. For the early gastric
      cancer, radical gastrectomy, is the most important treatment, which could significantly
      prolong disease-free survival and overall survival. However, the severe damage of surgery and
      following radiation and chemotherapy in intestinal tract usually leads patients to be a
      constitution of spleen qi deficiency, a concept of traditional Chinese medicine (TCM) that
      mainly involves digestive symptoms, such as poor appetite, abnormal stool (loose, diarrhea)
      and abdominal distention. Therefore, how to resolve and protect the function of intestinal
      tract, and change the constitution of spleen qi deficiency postoperatively is important for
      improving quality of life and reducing the recurrence rate of cancer.

      Shen Ling Bai Zhu San, a classic Chinese medicinal formulae originally described in Tai Ping
      Hui Min He Ji Ju Fang in the 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 that differs 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. Previous pharmacologic studies also 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.

      According to the experience of TCM, the constitution of patients who are undergoing radiation
      and chemotherapy is usually yin deficiency, but changes to spleen qi deficiency due to
      digestive disorders after those treatment. Therefore, Shen Ling Bai Zhu San is expected to
      improve symptoms in patients who underwent gastrectomy and following radiation and
      chemotherapy.

      Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, 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 for a long-term use. Hou Gu Mi Xi
      uses 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 be different.
      Therefore, the investigators plan to perform a hospital-based randomized controlled trial,
      enroll patients from three hospitals in Nanchang City of Jiangxi Province in China, for
      assessing efficacy and safety of Hou Gu Mi Xi on digestive symptoms in patients with spleen
      qi deficiency and radical gastrectomy for gastric cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes 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: Qualitative assessment of changes in total scores of SQD scale from baseline
time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
description: 1) completely remission: reduction in scores is ≥ 95% compared with baseline; 2) markedly effective: reduction in scores is 70% to 94% compared with baseline; 3) effective: reduction in scores is 30% to 69% compared with baseline; 4) not effective: reduction in scores is < 30% compared with baseline
measure: Changes in scores of each item of SQD scale from baseline
time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
description: 1) Stomach distension*, 2) Abdominal distension*, 3) Fatigue and weakness*, 4) Tired mind and taciturnity*, 5) Inappetence*, 6) Stomach pain, 7) Stomach tightness, 8) Abdominal pain, 9) Acid reflux, 10) Belching, 11) Nausea and vomiting, 12) Abnormal stools, 13) Abnormal bowel sounds, 14) Powerless defecation, 15) Sallow complexion, 16) Tastelessness and hypodipsia, and 17) Face and limbs edema.
measure: Changes from baseline in total scores of Short Form 36 (SF-36) (Units on a scale)
time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
description: To assess quality of life
measure: Changes from baseline in scores of subitems in Short Form 36 (SF-36) (Units on a scale)
time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
description: Physical Component Summary (PCS) and Mental Component Summary (MCS)
measure: Changes from baseline in scores of Eastern Cooperative Oncology Group (ECOG) Performance Status (Units on a scale)
time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
description: To assess performance status
measure: Progression free survival (month)
time frame: From the first dose of intervention up to 104 weeks
description: assessed by evidence of pathological examination, computed tomography and/or magnetic resonance imaging
measure: Changes from baseline in systolic blood pressure (mmHg)
time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
description: To determine whether the interventions improve systolic blood pressure
measure: Changes from baseline in diastolic blood pressure (mmHg)
time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
description: To determine whether the interventions improve diastolic blood pressure
measure: Changes from baseline in body weight (kg)
time frame: At baseline and 2, 4, 8, 26, 52, 78 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 2, 4, 8, 26, 52, 78 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: 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]), coagulation function (prothrombin time [PT], activated partial thromboplastin time [APTT], thrombin time [TT], fibrinogen [FIB]), and electrocardiogram as well as any other new-onset symptoms or diseases related or unrelated to the intervention
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 an oral dose of 10 g/day during entire follow up period (2 years).
arm group label: placebo
arm group type: Placebo Comparator
description: Patients in this arm receive placebo, with an oral dose of 10 g/day during entire follow up period (2 years).
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, 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: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Weifeng Zhu, Ph.D.
role: Study Chair
affiliation: Jiangxi University of Traditional Chinese Medicine
facility: 
country: China
citation: Oh SY, Lee HJ, Yang HK. Pylorus-Preserving Gastrectomy for Gastric Cancer. J Gastric Cancer. 2016 Jun;16(2):63-71. doi: 10.5230/jgc.2016.16.2.63. Epub 2016 Jun 24.
PMID: 27433390
citation: Yang L. Incidence and mortality of gastric cancer in China. World J Gastroenterol. 2006 Jan 7;12(1):17-20. doi: 10.3748/wjg.v12.i1.17.
PMID: 16440411
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: Principal Investigator
mesh term: Stomach Neoplasms
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases
sharing ipd: No
ipd description: The investigators do not plan to share individual participant data.