<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/NCT03837210</url>
  </required_header>
  <id_info>
    <org_study_id>zahoor11</org_study_id>
    <nct_id>NCT03837210</nct_id>
  </id_info>
  <brief_title>Comparative Anti Helicobacter Pylori Efficacy Assessment of Unani Formulation and Quintuple Regimen</brief_title>
  <official_title>Comparative Anti Helicobacter Pylori Efficacy Assessment of Unani Formulation and Quintuple Regimen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hamdard University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hamdard University</source>
  <oversight_info>
    <has_dmc>No</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>
      Helicobacter pylori (H. pylori) is a bacterium its infection is regarded the most common&#xD;
      medical condition associated with gastritis1 more over peptic ulcer disease2, gastric&#xD;
      adenocarcinoma3 and lymphoma.4control of H pylori infection is thought to be the solution of&#xD;
      public health problem.5,6 rate of infection is abating in developed world 7 , but this is&#xD;
      slow and people health is challenged, to stop or decrease the new cases is complicated&#xD;
      despite the fact that route of transmission are still unclear .8-10 The only option for&#xD;
      reducing incidence and prevalence is that screening of masses followed by eradication&#xD;
      therapy. A rough estimate propose about 50% of developing country population is affected from&#xD;
      infection than the industrialized country. Infected individual may be asymptomatic or some&#xD;
      time present with gastroduodenal disease. Prevalence of H pylori is different in developing&#xD;
      countries where the adult prevalence reaches up to 80% and in children it is found before the&#xD;
      age of 10 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Helicobacter pylori (H. pylori) is a bacterium its infection is regarded the most common&#xD;
      medical condition associated with gastritis1 more over peptic ulcer disease2, gastric&#xD;
      adenocarcinoma3 and lymphoma.4control of H pylori infection is thought to be the solution of&#xD;
      public health problem.5,6 rate of infection is abating in developed world 7 , but this is&#xD;
      slow and people health is challenged, to stop or decrease the new cases is complicated&#xD;
      despite the fact that route of transmission are still unclear .8-10 The only option for&#xD;
      reducing incidence and prevalence is that screening of masses followed by eradication&#xD;
      therapy. A rough estimate propose about 50% of developing country population is affected from&#xD;
      infection than the industrialized country. Infected individual may be asymptomatic or some&#xD;
      time present with gastroduodenal disease. Prevalence of H pylori is different in developing&#xD;
      countries where the adult prevalence reaches up to 80% and in children it is found before the&#xD;
      age of 10 years.&#xD;
&#xD;
      Aims and objectives&#xD;
&#xD;
        1. To establish and evaluate scientific and clinical evidence of herbal/eastern formulation&#xD;
           and find out the clinical safety and efficacy.&#xD;
&#xD;
        2. To measure the clinical response of herbal formulation in the patients of H.Pylori.&#xD;
&#xD;
      Research Questions&#xD;
&#xD;
      1. has the Unani formulation better effects than quadruple regimen?&#xD;
&#xD;
      Hypothesis (H1): Unani has shown better clinical, effects than quadruple regimen.&#xD;
&#xD;
      Null Hypothesis (Ho): Quadruple regimen has shown superior clinical, response than Unani&#xD;
      formulation.&#xD;
&#xD;
      Experimental approaches&#xD;
&#xD;
      To check this hypothesis independent variable to dependent variable and perplexing variables&#xD;
      will apply by statistical analysis. In this study H. Pylori infection, quadruple regimen are&#xD;
      independent variables while signs and symptoms, level of improvement are dependent variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2017</start_date>
  <completion_date type="Actual">January 10, 2019</completion_date>
  <primary_completion_date type="Actual">January 10, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eradication of H. Pylori</measure>
    <time_frame>4 week duration</time_frame>
    <description>Negative Stool antigen for H. pylori</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>H.Pylori Infection</condition>
  <arm_group>
    <arm_group_label>Test Drug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group is treated with Herbal formulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Drug</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group is treated with Quintuple therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pylorin</intervention_name>
    <description>Poly Herbal formulation</description>
    <arm_group_label>Control Drug</arm_group_label>
    <arm_group_label>Test Drug</arm_group_label>
    <other_name>Poly Herbal formulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The individuals suffering from H. pylori infection .&#xD;
&#xD;
          2. Individuals having no previous history of H. pylori infection treatment.&#xD;
&#xD;
          3. Individuals living in Karachi.&#xD;
&#xD;
          4. Individuals with no pathological finding on routine examination.&#xD;
&#xD;
          5. Individuals from either socioeconomic class including lower, middle and higher.&#xD;
&#xD;
          6. Both male and female individuals between 14 to 55 years of age&#xD;
&#xD;
          7. Subjects with informed written consent&#xD;
&#xD;
          8. Patients having no complications regarding other than GIT system.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        The following were the reason for excluding the individuals from this trial:&#xD;
&#xD;
          1. Patient with simultaneous physical illness, for example renal dialysis and&#xD;
             uncontrolled diabetes mellitus.&#xD;
&#xD;
          2. Individuals having stomach or intestinal surgical history were excluded.&#xD;
&#xD;
          3. Individuals with past record of any herbal or allopathic medication were excluded&#xD;
&#xD;
          4. Individuals with hyper sensitivity history of drug or adverse reaction to any of the&#xD;
             study drugs .&#xD;
&#xD;
          5. Females with pregnancy were also excluded for the safety measures&#xD;
&#xD;
          6. Individuals with coma, meningitis, and encephalitis or head injury were also excluded.&#xD;
&#xD;
          7. Hospitalized individuals due to any serious diseases were excluded.&#xD;
&#xD;
          8. Individuals with known poor compliance and history of drug abuse were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zahoor Zaidi, M.Phil</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hamdard University</affiliation>
  </overall_official>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hamdard University</investigator_affiliation>
    <investigator_full_name>Syed Zahoor Ul Hassan Zaidi</investigator_full_name>
    <investigator_title>Syed Zahoor Ul Hassan Zaidi</investigator_title>
  </responsible_party>
  <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/NCT03837210
org study id: zahoor11
nct id: NCT03837210
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Helicobacter pylori (H. pylori) is a bacterium its infection is regarded the most common
      medical condition associated with gastritis1 more over peptic ulcer disease2, gastric
      adenocarcinoma3 and lymphoma.4control of H pylori infection is thought to be the solution of
      public health problem.5,6 rate of infection is abating in developed world 7 , but this is
      slow and people health is challenged, to stop or decrease the new cases is complicated
      despite the fact that route of transmission are still unclear .8-10 The only option for
      reducing incidence and prevalence is that screening of masses followed by eradication
      therapy. A rough estimate propose about 50% of developing country population is affected from
      infection than the industrialized country. Infected individual may be asymptomatic or some
      time present with gastroduodenal disease. Prevalence of H pylori is different in developing
      countries where the adult prevalence reaches up to 80% and in children it is found before the
      age of 10 years.
Helicobacter pylori (H. pylori) is a bacterium its infection is regarded the most common
      medical condition associated with gastritis1 more over peptic ulcer disease2, gastric
      adenocarcinoma3 and lymphoma.4control of H pylori infection is thought to be the solution of
      public health problem.5,6 rate of infection is abating in developed world 7 , but this is
      slow and people health is challenged, to stop or decrease the new cases is complicated
      despite the fact that route of transmission are still unclear .8-10 The only option for
      reducing incidence and prevalence is that screening of masses followed by eradication
      therapy. A rough estimate propose about 50% of developing country population is affected from
      infection than the industrialized country. Infected individual may be asymptomatic or some
      time present with gastroduodenal disease. Prevalence of H pylori is different in developing
      countries where the adult prevalence reaches up to 80% and in children it is found before the
      age of 10 years.

      Aims and objectives

        1. To establish and evaluate scientific and clinical evidence of herbal/eastern formulation
           and find out the clinical safety and efficacy.

        2. To measure the clinical response of herbal formulation in the patients of H.Pylori.

      Research Questions

      1. has the Unani formulation better effects than quadruple regimen?

      Hypothesis (H1): Unani has shown better clinical, effects than quadruple regimen.

      Null Hypothesis (Ho): Quadruple regimen has shown superior clinical, response than Unani
      formulation.

      Experimental approaches

      To check this hypothesis independent variable to dependent variable and perplexing variables
      will apply by statistical analysis. In this study H. Pylori infection, quadruple regimen are
      independent variables while signs and symptoms, level of improvement are dependent variables.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Eradication of H. Pylori
time frame: 4 week duration
description: Negative Stool antigen for H. pylori
arm group label: Test Drug
arm group type: Experimental
description: This group is treated with Herbal formulation.
arm group label: Control Drug
arm group type: Active Comparator
description: This group is treated with Quintuple therapy
intervention type: Drug
intervention name: Pylorin
description: Poly Herbal formulation
arm group label: Control Drug
arm group label: Test Drug
other name: Poly Herbal formulation
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Zahoor Zaidi, M.Phil
role: Principal Investigator
affiliation: Hamdard University
responsible party type: Principal Investigator
investigator affiliation: Hamdard University
investigator full name: Syed Zahoor Ul Hassan Zaidi
investigator title: Syed Zahoor Ul Hassan Zaidi
sharing ipd: No