<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/NCT03018821</url>
  </required_header>
  <id_info>
    <org_study_id>XAZYYLS2017-02</org_study_id>
    <nct_id>NCT03018821</nct_id>
  </id_info>
  <brief_title>The Study of Two Different Chinese Traditional Medicine Treatment on Chronic Hepatitis B</brief_title>
  <official_title>Efficacy Comparison Between Two Kind of Chinese Herbal Formulas on Traditional Chinese Medicine Syndromes Among Chronic Hepatitis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xi'an Traditional Medicine Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xi'an Traditional Medicine Hospital</source>
  <brief_summary>
    <textblock>
      Although the incidence of Hepatitis B has been decreased a lot recently years, there are&#xD;
      still quite a few chronic hepatitis B patients in China. The anti-virus drugs of western&#xD;
      medicine such as Entecavir and Tenofovir have been proved effective on decreasing the serum&#xD;
      hepatitis B virus (HBV) level, on the other hand, Chinese materia medica showed effective on&#xD;
      TCM syndromes of chronic hepatitis B (CHB) such as hypochondriac pain, jaundice and abdominal&#xD;
      mass. Besides, the hepatic fibrosis could be delayed after the appropriate treatment of TCM.&#xD;
      This study is a multicenter, randomized, open label, parallel group clinical trial to&#xD;
      evaluate the efficacy of two different traditional Chinese medicine (TCM) herbal treatment on&#xD;
      chronic hepatitis B.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Traditional Chinese Medicine symptom scale</measure>
    <time_frame>Change of TCM symptom scale between baseline and sixth months of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of liver fibrosis</measure>
    <time_frame>Chnage of liver fibrosis between baseline and 6th months of treatment</time_frame>
    <description>Use change of FibroScan measurement of liver between baseline and 6th months of treatment to express the change of liver fibrosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall effectiveness of treatment defined by the guidelines for prevention and treatment of chronic hepatitis B</measure>
    <time_frame>Overall effectiveness of treatment between baseline and 6th months of treatment</time_frame>
    <description>Treatments were completely effective, partially effective or not effective after treatment.&#xD;
Complete effective: Alanine aminotransferase normal, HBV DNA, HBeAg and HBsAg are negative&#xD;
Partially effective: Alanine aminotransferase normal, HBV DNA, HBeAg are negative and HBsAg stay positive&#xD;
Not effective: Did not reach any one of what are listed above.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Hepatitis B， Chronic</condition>
  <arm_group>
    <arm_group_label>Standard CMF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir).&#xD;
Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao&#xD;
Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation&#xD;
Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency.&#xD;
Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney&#xD;
Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney&#xD;
Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Advanced CMF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Advanced TCM formulas for corresponding TCM syndromes provided by famous TCM doctors who were national wide known in China, plus an anti-virus western drugs (such as Entecavir or Tenofovir).&#xD;
Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao&#xD;
Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation&#xD;
Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency.&#xD;
Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney&#xD;
Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney&#xD;
Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pure Entecavir or Tenofovir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use an anti-virus western drug alone (such as Entecavir or Tenofovir).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard - Yinchengao Decoction plus Ganlu Detoxification Pill</intervention_name>
    <description>Yinchengao Decoction plus Ganlu Detoxification Pill is one Chinese Medicine Formula for the TCM syndrome: Damp-heat blocking middle jiao.</description>
    <arm_group_label>Standard CMF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Entecavir or Tenofovir</intervention_name>
    <description>Western drug for anti-HBV such as Entecavir and Tenofovir</description>
    <arm_group_label>Advanced CMF</arm_group_label>
    <arm_group_label>Pure Entecavir or Tenofovir</arm_group_label>
    <arm_group_label>Standard CMF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard - Ge Xia Zhu Yu Decoction</intervention_name>
    <description>Ge Xia Zhu Yu Decoction is one Chinese Medicine Formula for the TCM syndrome: internal blood stasis.</description>
    <arm_group_label>Standard CMF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Advanced - Supplemented Taohong Huazhuo Decoction</intervention_name>
    <description>Supplemented Taohong Huazhuo Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Damp-heat blocking middle jiao.</description>
    <arm_group_label>Advanced CMF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard - Chaihu Shugan San</intervention_name>
    <description>Chaihu Shugan San is one Chinese Medicine Formula for the TCM syndrome: Liver depression and qi stagnation.</description>
    <arm_group_label>Standard CMF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Advanced - Soothe the liver and regulate qi Decoction</intervention_name>
    <description>Soothe the liver and regulate qi Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Liver depression and qi stagnation.</description>
    <arm_group_label>Advanced CMF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard - Xiaoyao powder</intervention_name>
    <description>Xiaoyao powder is one Chinese Medicine Formula for the TCM syndrome: Stagnation of liver qi and spleen deficiency.</description>
    <arm_group_label>Standard CMF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Advanced - Supplemented Ganbi Decoction</intervention_name>
    <description>Supplemented Ganbi Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Stagnation of liver qi and spleen deficiency.</description>
    <arm_group_label>Advanced CMF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard - Yiguan Decoction</intervention_name>
    <description>Yiguan Decoction is one Chinese Medicine Formula for the TCM syndrome: Yin deficiency of liver and kidney.</description>
    <arm_group_label>Standard CMF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Advanced - Supplemented Zimu Dan</intervention_name>
    <description>Supplemented Zimu Dan is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Yin deficiency of liver and kidney.</description>
    <arm_group_label>Advanced CMF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus</intervention_name>
    <description>Fuzilizhong Decoction plus Jinkui Shenqi Bolus is one Chinese Medicine Formula for the TCM syndrome: Yang deficiency of spleen and kidney.</description>
    <arm_group_label>Standard CMF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Advanced - Guifu Erxian Decoction</intervention_name>
    <description>Guifu Erxian Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Yang deficiency of spleen and kidney.</description>
    <arm_group_label>Advanced CMF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Advanced - Supplemented Ganji Decoction</intervention_name>
    <description>Supplemented Ganji Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: internal blood stasis.</description>
    <arm_group_label>Advanced CMF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18&lt;=age at treatment&lt;=65 years old&#xD;
&#xD;
          -  Was diagnosed as chronic hepatitis B (ICD10:K73.901) and one of the following Chinese&#xD;
             syndromes: hypochondriac pain (TCD:BNG010), jaundice(TCD:BNG020) or abdominal mass&#xD;
             (TCD:BNG040).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Combined with other virus hepatitis or alcoholic hepatitis&#xD;
&#xD;
          -  Combined with autoimmune disease&#xD;
&#xD;
          -  Combined with liver cancer or cirrhosis&#xD;
&#xD;
          -  Combined with severe hepatitis with or without complications&#xD;
&#xD;
          -  Combined with unstable cardio-cerebrovascular disease&#xD;
&#xD;
          -  Combined with severe lung, kidney, endocrine system, nervous system and hematological&#xD;
             system diseases&#xD;
&#xD;
          -  Combined with Tuberculosis&#xD;
&#xD;
          -  Chronic hepatitis patients with ongoing INF treatment&#xD;
&#xD;
          -  Woman with pregnancy or breasting feeding&#xD;
&#xD;
          -  Mental disorder and can not express self clearly&#xD;
&#xD;
          -  Cannot speak Chinese&#xD;
&#xD;
          -  Allergic constitution or allergy to multiple drugs&#xD;
&#xD;
          -  Refuse to enroll into the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jianmei Hao, MD</last_name>
    <phone>86-29-89626651</phone>
    <email>12479088@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xi'an Traditional Medicine Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianmei Hao, MD</last_name>
      <phone>86-29-89626651</phone>
      <email>12479088@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 6, 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>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Entecavir</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03018821
org study id: XAZYYLS2017-02
nct id: NCT03018821
lead sponsor: 
Although the incidence of Hepatitis B has been decreased a lot recently years, there are
      still quite a few chronic hepatitis B patients in China. The anti-virus drugs of western
      medicine such as Entecavir and Tenofovir have been proved effective on decreasing the serum
      hepatitis B virus (HBV) level, on the other hand, Chinese materia medica showed effective on
      TCM syndromes of chronic hepatitis B (CHB) such as hypochondriac pain, jaundice and abdominal
      mass. Besides, the hepatic fibrosis could be delayed after the appropriate treatment of TCM.
      This study is a multicenter, randomized, open label, parallel group clinical trial to
      evaluate the efficacy of two different traditional Chinese medicine (TCM) herbal treatment on
      chronic hepatitis B.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Traditional Chinese Medicine symptom scale
time frame: Change of TCM symptom scale between baseline and sixth months of treatment
measure: The change of liver fibrosis
time frame: Chnage of liver fibrosis between baseline and 6th months of treatment
description: Use change of FibroScan measurement of liver between baseline and 6th months of treatment to express the change of liver fibrosis
measure: Overall effectiveness of treatment defined by the guidelines for prevention and treatment of chronic hepatitis B
time frame: Overall effectiveness of treatment between baseline and 6th months of treatment
description: Treatments were completely effective, partially effective or not effective after treatment.
Complete effective: Alanine aminotransferase normal, HBV DNA, HBeAg and HBsAg are negative
Partially effective: Alanine aminotransferase normal, HBV DNA, HBeAg are negative and HBsAg stay positive
Not effective: Did not reach any one of what are listed above.
arm group label: Standard CMF
arm group type: Active Comparator
description: Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir).
Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation
Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney
Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney
Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis
arm group label: Advanced CMF
arm group type: Experimental
description: Advanced TCM formulas for corresponding TCM syndromes provided by famous TCM doctors who were national wide known in China, plus an anti-virus western drugs (such as Entecavir or Tenofovir).
Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation
Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney
Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney
Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis
arm group label: Pure Entecavir or Tenofovir
arm group type: Experimental
description: Use an anti-virus western drug alone (such as Entecavir or Tenofovir).
intervention type: Drug
intervention name: Standard - Yinchengao Decoction plus Ganlu Detoxification Pill
description: Yinchengao Decoction plus Ganlu Detoxification Pill is one Chinese Medicine Formula for the TCM syndrome: Damp-heat blocking middle jiao.
arm group label: Standard CMF
intervention type: Drug
intervention name: Entecavir or Tenofovir
description: Western drug for anti-HBV such as Entecavir and Tenofovir
arm group label: Advanced CMF
arm group label: Pure Entecavir or Tenofovir
arm group label: Standard CMF
intervention type: Drug
intervention name: Standard - Ge Xia Zhu Yu Decoction
description: Ge Xia Zhu Yu Decoction is one Chinese Medicine Formula for the TCM syndrome: internal blood stasis.
arm group label: Standard CMF
intervention type: Drug
intervention name: Advanced - Supplemented Taohong Huazhuo Decoction
description: Supplemented Taohong Huazhuo Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Damp-heat blocking middle jiao.
arm group label: Advanced CMF
intervention type: Drug
intervention name: Standard - Chaihu Shugan San
description: Chaihu Shugan San is one Chinese Medicine Formula for the TCM syndrome: Liver depression and qi stagnation.
arm group label: Standard CMF
intervention type: Drug
intervention name: Advanced - Soothe the liver and regulate qi Decoction
description: Soothe the liver and regulate qi Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Liver depression and qi stagnation.
arm group label: Advanced CMF
intervention type: Drug
intervention name: Standard - Xiaoyao powder
description: Xiaoyao powder is one Chinese Medicine Formula for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
arm group label: Standard CMF
intervention type: Drug
intervention name: Advanced - Supplemented Ganbi Decoction
description: Supplemented Ganbi Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
arm group label: Advanced CMF
intervention type: Drug
intervention name: Standard - Yiguan Decoction
description: Yiguan Decoction is one Chinese Medicine Formula for the TCM syndrome: Yin deficiency of liver and kidney.
arm group label: Standard CMF
intervention type: Drug
intervention name: Advanced - Supplemented Zimu Dan
description: Supplemented Zimu Dan is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Yin deficiency of liver and kidney.
arm group label: Advanced CMF
intervention type: Drug
intervention name: Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus
description: Fuzilizhong Decoction plus Jinkui Shenqi Bolus is one Chinese Medicine Formula for the TCM syndrome: Yang deficiency of spleen and kidney.
arm group label: Standard CMF
intervention type: Drug
intervention name: Advanced - Guifu Erxian Decoction
description: Guifu Erxian Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Yang deficiency of spleen and kidney.
arm group label: Advanced CMF
intervention type: Drug
intervention name: Advanced - Supplemented Ganji Decoction
description: Supplemented Ganji Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: internal blood stasis.
arm group label: Advanced CMF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jianmei Hao, MD
phone: 86-29-89626651
email: 12479088@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Tenofovir
mesh term: Entecavir