<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/NCT03825692</url>
  </required_header>
  <id_info>
    <org_study_id>2017YFC1703703</org_study_id>
    <nct_id>NCT03825692</nct_id>
  </id_info>
  <brief_title>International Clinical Study of Zhizhu Kuanzhong Capsule</brief_title>
  <official_title>A Multi-center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Clinical Trial of Zhizhu Kuanzhong Capsule in Treating Patients With Postprandial Distress Syndrome of Functional Dyspepsia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiyuan Hospital of China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xiyuan Hospital of China Academy of Chinese Medical Sciences</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 evaluate the clinical efficacy and safety of Zhizhu Kuanzhong Capsule in&#xD;
      the treating patients with functional dyspepsia postprandial distress syndrome(FD PDS). Half&#xD;
      of participants will receive Zhizhu Kuanzhong Capsule,while the other will receive a placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders.&#xD;
      Current data from clinical studies have shown that traditional Chinese medicine can obviously&#xD;
      relieve clinical symptoms of patients with FD, and has special advantages and good clinical&#xD;
      application prospects in the treatment of FD. Zhizhu Kuanzhong Capsule is mainly composed of&#xD;
      the following 4 kinds of Chinese herbs: Rhizoma Atractylodis Macrocephala, Fructus Aurantii&#xD;
      Immaturus, Radix Bupleuri and Fructus Crataegi. This trial aims to evaluate the clinical&#xD;
      efficacy and safety of Zhizhu Kuanzhong Capsule in the treating patients with functional&#xD;
      dyspepsia postprandial distress syndrome(FD PDS). This is a multi-center, stratified-block&#xD;
      randomized, double-blind and placebo parallel-controlled trial. The comparison between the&#xD;
      investigational drug and the placebo will be conducted with superiority design. About 480&#xD;
      subjects matched Rome IV diagnostic criteria for FD PDS will be enrolled. For each subject,&#xD;
      this study includes a 0-2 week screening period, a 1-week run-in period, an 8-week&#xD;
      double-blind treatment period, and a 4-week follow-up period. The drugs used in the clinical&#xD;
      study (including investigational drug and placebo) will be supplied by Shuangren&#xD;
      Pharmaceutical Co., Ltd. of Lonch Group.The quality standards and test methods for the&#xD;
      placebo are consistent with those for the investigational drug, and the quality test meets&#xD;
      the proposed quality standards. The selection and evaluation bias are controlled by means of&#xD;
      strictly implementing randomized control blinded method etc, and the investigator will be&#xD;
      trained on the consistency of scale evaluation.The electronic case report form (hereinafter&#xD;
      referred to as eCRF) of this trial is created using the Medical Clinical Trial Data&#xD;
      Management System (eCDMS3.0) for online data acquisition and management via the Internet. The&#xD;
      data in the eCRF are from the original documents such as the original medical records and the&#xD;
      physicochemical examination report sheets and should be consistent with the original&#xD;
      documents. The response rate for functional dyspepsia VAS score will be compared between the&#xD;
      test group and control group at 8 weeks after randomization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 24, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>
    <intervention_model_description>Randomized, double-blind, placebo-controlled, multi-center</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of the response at 8 weeks after randomization</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>Subjects with the functional dyspepsia-postprandial distress syndrome are self-rated on the Visual Analogue Score (VAS) which is a scale of 0-10, with subjects indicating the degree of discomfort on a 10 cm ruler marked 0- &quot;Asymptomatic or No Discomfort &quot;to 10- &quot;Extreme Severe or Extreme Discomfort &quot;at its head and tail, respectively. The record is made once a day and 7 days a week via a diary card. For VAS scores for postprandial fullness discomfort and early satiety, the integral average for both symptoms over the past week is evaluated, and a 50% decrease from baseline in the integral average at 8 Weeks is recorded as a response.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of VAS score of each symptom of functional dyspepsia</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>On the diary cards, subjects recorded the Visual Analogue Score (VAS) of each symptom of the functional dyspepsia daily. VAS is scored on a scale of 0-10 which the higher the score, the severer the symptom is. The record is made once a day and 7 days. The investigators use the average of the weekly VAS scores as the symptom intensity score for this week, with one VAS score per week. The change in the score of each symptom at 8 weeks after randomization relative to the baseline is evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall treatment response rate</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>The overall treatment efficacy is evaluated using a 7-point Likert Overall Evaluation Scale (OTE). The clinical investigators asked the subjects the following questions weekly: &quot;In the last week, how much have your dyspeptic symptoms been alleviated as compared to pre-treatment? &quot; There are 7 options: ① the symptoms improved significantly, ② the symptoms improved, ③ the symptoms improved slightly, ④ the symptoms did not change, ⑤ the symptoms aggravated slightly, ⑥ the symptoms aggravated, ⑦ the symptoms aggravated significantly. At the last visit time point of the treatment cycle, patients who selected ① and ② were defined as treatment responders, and those who selected ③-⑦ were defined as non-responders. The response rate at 8 weeks after randomization between the groups are compared for differences.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form Nepean Dyspepsia Index (SFNDI)</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Short Form-Nepean Dyspepsia Index (SFNDI) is a reliable and valid measure of quality of life in functional dyspepsia with 10 items which questions are about how subjects stomach pain, discomfort, or other epigastric symptoms over the last 14 days affect their lives. Add up the ten items for each of the five sub-scale scores (range of each sub-scale 2-10). The changes of SFNDI score at 4 weeks and 8 weeks after randomization relative to the baseline are calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale score</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>The Hospital Anxiety and Depression Scale (HAD) is mainly used in patients in general hospitals which provides two sets of tests to assess the state of anxiety and depression, respectively. Among them, A stands for anxiety items, D stands for depression items, and each item is scored at four levels. Each of the two sets of items are superimposed to obtain their respective total score. A total score of 0 to 7 indicates normal, 8 to 10 indicates borderline abnormal, and 11 to 21 indicates abnormal. The changes of HAD score at 4 weeks and 8 weeks after randomization relative to the baseline are calculated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">480</enrollment>
  <condition>Functional Dyspepsia</condition>
  <condition>Postprandial Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>Zhizhu Kuanzhong Capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Zhizhu Kuanzhong Capsule Arm is Zhizhu Kuanzhong Capsule, Specification: 0.43 g/granule; Manufacturer: Lonch Group, Shuangren Pharmaceutical Co., Ltd. ; Approval number: NMPA approval number: GUOYAOZHUNZI Z20020003; Dosage and administration: 3 capsules at a time, 3 times a day, taken orally 10-15 min before meals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Zhizhu Kuanzhong Placebo Capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Zhizhu Kuanzhong Placebo Capsule Arm is Zhizhu Kuanzhong Capsule Mimics composed of microcrystalline cellulose, mannitol and magnesium stearate, which used for filling agent and lubricant respectively; Specification: 0.43 g/granule; Manufacturer: Lonch Group, Shuangren Pharmaceutical Co., Ltd.; Dosage and administration: Be identical with the investigational drug.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zhizhu Kuanzhong Capsule</intervention_name>
    <description>Zhizhu Kuanzhong Capsule, 3 capsules at a time, 3 times a day, taken orally 10-15 min before meals. an 8-week intervention period</description>
    <arm_group_label>Zhizhu Kuanzhong Capsule</arm_group_label>
    <other_name>ZZKZ capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zhizhu Kuanzhong Placebo Capsule</intervention_name>
    <description>Placebo, 3 capsules at a time, 3 times a day, taken orally 10-15 min before meals. an 8-week intervention period</description>
    <arm_group_label>Zhizhu Kuanzhong Placebo Capsule</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Meeting the Rome IV diagnostic criteria for functional dyspepsia-postprandial distress&#xD;
             syndrome;&#xD;
&#xD;
          2. * At least 3 days during the one-week run-in period with VAS score ≥ 4 for major&#xD;
             symptoms (at least one of postprandial fullness discomfort and early satiety) .&#xD;
&#xD;
          3. Age between 18 and 65 years old (including 18 and 65 years old), male or female,&#xD;
             outpatients;&#xD;
&#xD;
          4. **Be able to discontinue prohibited medications that may affect the evaluation of the&#xD;
             effectiveness, such as acid inhibition/antacids, prokinetic agents, non-steroidal&#xD;
             anti-inflammatory drugs, anticholinergic agents, glucocorticoids, and therapeutic&#xD;
             medication for H. pylori eradication.&#xD;
&#xD;
          5. Each subject is informed and voluntarily signed the informed consent form(ICF).&#xD;
&#xD;
               -  Subjects who entered the one-week run-in period are self-rated on the Visual&#xD;
                  Analogue Score (VAS) for the degree of discomfort with both symptoms of&#xD;
                  postprandial fullness and early fullness, with subjects indicating the degree of&#xD;
                  discomfort on a 10 cm ruler marked 0- &quot;Asymptomatic or No Discomfort&quot;and 10-&#xD;
                  &quot;Extreme Severe or Extreme Discomfort&quot;at its head and tail, respectively. The&#xD;
                  rating was made once a day and 7 days a week with scores of 0 to 10.&#xD;
&#xD;
                    -  A 2-week wash-out period is required for patients taking prohibited&#xD;
                       medications prior to screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Gastroscopic findings of gastric cancer, peptic ulcer, erosive gastritis (grade 2 or&#xD;
             higher), moderate to severe atrophic gastritis, dysplasia, or other organ&#xD;
             gastrointestinal disease.&#xD;
&#xD;
          2. Patients with a history of abdominal surgery (except for appendectomy and cesarean&#xD;
             section).&#xD;
&#xD;
          3. Patients with immune system defects (such as leukaemia or cancer), or those who have&#xD;
             been administered immunosuppressive agents or glucocorticoids within the past 3&#xD;
             months.&#xD;
&#xD;
          4. Patients who combined severe cardiac and pulmonary insufficiency, insufficiency of&#xD;
             liver (ALT/AST &gt; 1.5 times the upper limit of the normal value) and kidney&#xD;
             insufficiency (BUN/Serum Creatinine &gt; the upper limit of the normal value), abnormal&#xD;
             of endocrine system( such as diabetes and thyroid dysfunction), abnormal hematopoietic&#xD;
             system, and iron deficiency anemia as indicated on hematological examination.&#xD;
&#xD;
          5. Patients with severe anxiety and depression.&#xD;
&#xD;
          6. Patients with psychosis and mental retardation as well as language disorder precluding&#xD;
             the ability of filling scales or recording symptoms.&#xD;
&#xD;
          7. Pregnant (a female of childbearing potential with a positive pregnancy test) or&#xD;
             lactating females; or patients of childbearing potential without effective&#xD;
             contraception.&#xD;
&#xD;
          8. Patients who are known to be allergic to the ingredients of this drug.&#xD;
&#xD;
          9. Patients who are suspected to have or indeed have a history of alcohol or drug abuse.&#xD;
&#xD;
         10. Patients who have participated in a clinical trial in the past 3 months.&#xD;
&#xD;
         11. Patients who are deemed by the investigator as being not suitable for participation in&#xD;
             the clinical trial.&#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_official>
    <last_name>Fang Lu, Md, Phd</last_name>
    <role>Study Director</role>
    <affiliation>Xiyuan Hospital of China Academy of Chinese Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fang Lu, MD,Phd</last_name>
    <phone>+861062835652</phone>
    <email>deerfang@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yingpan Zhao, MD,Phd</last_name>
    <phone>86015810964983</phone>
    <email>zypzyp1984@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Gerald Holtmann</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xiyuan Hospital of China Academy of Chinese Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100091</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fang Lu, Phd</last_name>
      <phone>+861062835652</phone>
      <email>deerfang@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Jishuitan Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yu Lan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital of Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaohong Sun</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fujian Provincial Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital of Chinese Academy of Medical Sciences</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yinglian Xiao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou University of Chinese Medicine</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fengbin Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hong Kong Baptist University</name>
      <address>
        <city>Hong Kong</city>
        <state>Hongokng</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Linda Zhong</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wuhan Union Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaohua Hou</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guoxin Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital Affiliated to China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kulun Qimeng Hospital</name>
      <address>
        <city>Tongliao</city>
        <state>Neimenggu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Duowu Zou</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Shaanxi University of traditional Chinese medicine</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiehong Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shaanxi Academy of Traditional Chinese Medicine</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tao Yu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinghai Wang</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>China</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>August 2, 2023</last_update_submitted>
  <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Functional Dyspepsia</keyword>
  <keyword>Postprandial Distress Syndrome</keyword>
  <keyword>Traditional Chinese Medicine</keyword>
  <keyword>efficacy</keyword>
  <keyword>safety</keyword>
  <keyword>clinical evaluation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Dyspepsia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03825692
org study id: 2017YFC1703703
nct id: NCT03825692
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This trial aims to evaluate the clinical efficacy and safety of Zhizhu Kuanzhong Capsule in
      the treating patients with functional dyspepsia postprandial distress syndrome(FD PDS). Half
      of participants will receive Zhizhu Kuanzhong Capsule,while the other will receive a placebo.
Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders.
      Current data from clinical studies have shown that traditional Chinese medicine can obviously
      relieve clinical symptoms of patients with FD, and has special advantages and good clinical
      application prospects in the treatment of FD. Zhizhu Kuanzhong Capsule is mainly composed of
      the following 4 kinds of Chinese herbs: Rhizoma Atractylodis Macrocephala, Fructus Aurantii
      Immaturus, Radix Bupleuri and Fructus Crataegi. This trial aims to evaluate the clinical
      efficacy and safety of Zhizhu Kuanzhong Capsule in the treating patients with functional
      dyspepsia postprandial distress syndrome(FD PDS). This is a multi-center, stratified-block
      randomized, double-blind and placebo parallel-controlled trial. The comparison between the
      investigational drug and the placebo will be conducted with superiority design. About 480
      subjects matched Rome IV diagnostic criteria for FD PDS will be enrolled. For each subject,
      this study includes a 0-2 week screening period, a 1-week run-in period, an 8-week
      double-blind treatment period, and a 4-week follow-up period. The drugs used in the clinical
      study (including investigational drug and placebo) will be supplied by Shuangren
      Pharmaceutical Co., Ltd. of Lonch Group.The quality standards and test methods for the
      placebo are consistent with those for the investigational drug, and the quality test meets
      the proposed quality standards. The selection and evaluation bias are controlled by means of
      strictly implementing randomized control blinded method etc, and the investigator will be
      trained on the consistency of scale evaluation.The electronic case report form (hereinafter
      referred to as eCRF) of this trial is created using the Medical Clinical Trial Data
      Management System (eCDMS3.0) for online data acquisition and management via the Internet. The
      data in the eCRF are from the original documents such as the original medical records and the
      physicochemical examination report sheets and should be consistent with the original
      documents. The response rate for functional dyspepsia VAS score will be compared between the
      test group and control group at 8 weeks after randomization.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, double-blind, placebo-controlled, multi-center
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The proportion of the response at 8 weeks after randomization
time frame: up to 8 weeks
description: Subjects with the functional dyspepsia-postprandial distress syndrome are self-rated on the Visual Analogue Score (VAS) which is a scale of 0-10, with subjects indicating the degree of discomfort on a 10 cm ruler marked 0- "Asymptomatic or No Discomfort "to 10- "Extreme Severe or Extreme Discomfort "at its head and tail, respectively. The record is made once a day and 7 days a week via a diary card. For VAS scores for postprandial fullness discomfort and early satiety, the integral average for both symptoms over the past week is evaluated, and a 50% decrease from baseline in the integral average at 8 Weeks is recorded as a response.
measure: The change of VAS score of each symptom of functional dyspepsia
time frame: Up to 8 weeks
description: On the diary cards, subjects recorded the Visual Analogue Score (VAS) of each symptom of the functional dyspepsia daily. VAS is scored on a scale of 0-10 which the higher the score, the severer the symptom is. The record is made once a day and 7 days. The investigators use the average of the weekly VAS scores as the symptom intensity score for this week, with one VAS score per week. The change in the score of each symptom at 8 weeks after randomization relative to the baseline is evaluated.
measure: Overall treatment response rate
time frame: Up to 8 weeks
description: The overall treatment efficacy is evaluated using a 7-point Likert Overall Evaluation Scale (OTE). The clinical investigators asked the subjects the following questions weekly: "In the last week, how much have your dyspeptic symptoms been alleviated as compared to pre-treatment? " There are 7 options: ① the symptoms improved significantly, ② the symptoms improved, ③ the symptoms improved slightly, ④ the symptoms did not change, ⑤ the symptoms aggravated slightly, ⑥ the symptoms aggravated, ⑦ the symptoms aggravated significantly. At the last visit time point of the treatment cycle, patients who selected ① and ② were defined as treatment responders, and those who selected ③-⑦ were defined as non-responders. The response rate at 8 weeks after randomization between the groups are compared for differences.
measure: Short Form Nepean Dyspepsia Index (SFNDI)
time frame: Up to 8 weeks
description: Short Form-Nepean Dyspepsia Index (SFNDI) is a reliable and valid measure of quality of life in functional dyspepsia with 10 items which questions are about how subjects stomach pain, discomfort, or other epigastric symptoms over the last 14 days affect their lives. Add up the ten items for each of the five sub-scale scores (range of each sub-scale 2-10). The changes of SFNDI score at 4 weeks and 8 weeks after randomization relative to the baseline are calculated.
measure: Hospital Anxiety and Depression Scale score
time frame: Up to 8 weeks
description: The Hospital Anxiety and Depression Scale (HAD) is mainly used in patients in general hospitals which provides two sets of tests to assess the state of anxiety and depression, respectively. Among them, A stands for anxiety items, D stands for depression items, and each item is scored at four levels. Each of the two sets of items are superimposed to obtain their respective total score. A total score of 0 to 7 indicates normal, 8 to 10 indicates borderline abnormal, and 11 to 21 indicates abnormal. The changes of HAD score at 4 weeks and 8 weeks after randomization relative to the baseline are calculated.
arm group label: Zhizhu Kuanzhong Capsule
arm group type: Experimental
description: Zhizhu Kuanzhong Capsule Arm is Zhizhu Kuanzhong Capsule, Specification: 0.43 g/granule; Manufacturer: Lonch Group, Shuangren Pharmaceutical Co., Ltd. ; Approval number: NMPA approval number: GUOYAOZHUNZI Z20020003; Dosage and administration: 3 capsules at a time, 3 times a day, taken orally 10-15 min before meals
arm group label: Zhizhu Kuanzhong Placebo Capsule
arm group type: Placebo Comparator
description: Zhizhu Kuanzhong Placebo Capsule Arm is Zhizhu Kuanzhong Capsule Mimics composed of microcrystalline cellulose, mannitol and magnesium stearate, which used for filling agent and lubricant respectively; Specification: 0.43 g/granule; Manufacturer: Lonch Group, Shuangren Pharmaceutical Co., Ltd.; Dosage and administration: Be identical with the investigational drug.
intervention type: Drug
intervention name: Zhizhu Kuanzhong Capsule
description: Zhizhu Kuanzhong Capsule, 3 capsules at a time, 3 times a day, taken orally 10-15 min before meals. an 8-week intervention period
arm group label: Zhizhu Kuanzhong Capsule
other name: ZZKZ capsule
intervention type: Drug
intervention name: Zhizhu Kuanzhong Placebo Capsule
description: Placebo, 3 capsules at a time, 3 times a day, taken orally 10-15 min before meals. an 8-week intervention period
arm group label: Zhizhu Kuanzhong Placebo Capsule
other name: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Fang Lu, Md, Phd
role: Study Director
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
last name: Fang Lu, MD,Phd
phone: +861062835652
email: deerfang@126.com
last name: Yingpan Zhao, MD,Phd
phone: 86015810964983
email: zypzyp1984@163.com
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status: Not yet recruiting
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status: Completed
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country: Australia
country: China
responsible party type: Sponsor
mesh term: Syndrome
mesh term: Dyspepsia
sharing ipd: No