xml: <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/NCT06041932</url>
    </required_header>
    <id_info>
      <org_study_id>ILBS-Cirrhosis-62</org_study_id>
      <nct_id>NCT06041932</nct_id>
    </id_info>
    <brief_title>Pentoxifylline Plus Carvedilol vs Carvedilol Monotherapy in Preventing New Decompensation in Stable Cirrhotic Patients With Prior Decompensation</brief_title>
    <official_title>Pentoxifylline Plus Carvedilol vs Carvedilol Monotherapy in Preventing New Decompensation in Stable Cirrhotic Patients With Prior Decompensation, an Open Label Randomised Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute of Liver and Biliary Sciences, India</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institute of Liver and Biliary Sciences, India</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>
        Cirrhotics with decompensation have increased risk of morbidity and mortality. There is&#xD;
        increased portal pressure leading to decompensation. Carvedilol is a standard therapy given&#xD;
        to cirrhotic patient with clinically significant portal hypertension to reduce portal&#xD;
        pressure. Pentoxifylline is a nonspecific phosphodiesterase inhibitor with anti-inflammatory&#xD;
        properties. It reduces portal hypertension, decreases lipopolysaccharide-induced liver&#xD;
        injury, improves nonalcoholic steatohepatitis, prevents development of HRS in ascites and&#xD;
        SAH, prevents hepatopulmonary syndrome. We want to study whether addition of pentoxifylline&#xD;
        to carvediolol vs carvedilol monotherapy reduces the risk of mortality and further&#xD;
        decompensation in cirrhotics with prior decompensation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        -  Study population: Cirrhotic patients with prior decompensation at least 1 year ago&#xD;
  &#xD;
          -  Study design: Open label randomized controlled trial&#xD;
  &#xD;
          -  Sample size Assuming decompensation in Arm 1 as 25%, and 10% in Arm 2, alpha error- 5,&#xD;
             power - 80, 160 patients, 10 % lost to follow up - 180, Each arm 90 patients.&#xD;
  &#xD;
          -  Intervention Arm 1 : Carvedilol Arm 2 : Pentoxiphylline plus Carvedilol&#xD;
  &#xD;
          -  Monitoring and assessment&#xD;
  &#xD;
        At enrollment:&#xD;
  &#xD;
          -  - Complete history and physical examination&#xD;
  &#xD;
          -  Prior ascites, Hepatic encephalopathy, acute variceal bleed.&#xD;
  &#xD;
          -  Time to prior decompensation&#xD;
  &#xD;
          -  Pattern and number of prior decompensation&#xD;
  &#xD;
          -  Prior spontaneous bacterial peritonitis, hydrothorax, Acute on chronic liver failure,&#xD;
             acute kidney injury&#xD;
  &#xD;
          -  Use of Non selective beta blockers, norfloxaxin, rifaximin and albumin&#xD;
  &#xD;
          -  Recent herbal/drugs intake&#xD;
  &#xD;
          -  History of EVL or other endotherapy&#xD;
  &#xD;
          -  History of hypertension, diabetes mellitus&#xD;
  &#xD;
          -  Fever , signs of sepsis&#xD;
  &#xD;
          -  Examination- Sarcopenia, fraility, icterus, pedal edema&#xD;
  &#xD;
        At follow-up (at 3 month, 6 month, 9 month, 12 month): Physical (preferably)&#xD;
  &#xD;
        • Complete history and physical examination&#xD;
  &#xD;
          -  New onset ascites, Hepatic encephalopathy, acute variceal bleed, clinical Jaundice&#xD;
  &#xD;
          -  Time to new decompensation from enrollment&#xD;
  &#xD;
          -  Pattern and number of new decompensation&#xD;
  &#xD;
          -  Other complications - Spontaneous bacterial peritonitis, hydrothorax, Acute on chronic&#xD;
             liver failure, acute kidney injury.&#xD;
  &#xD;
          -  Recent herbal/drugs intake&#xD;
  &#xD;
          -  History of EVL or other endotherapy&#xD;
  &#xD;
          -  Hypertension, Diabetes control&#xD;
  &#xD;
          -  Fever , signs of sepsis&#xD;
  &#xD;
          -  Examination- Sarcopenia, fraility, icterus, pedal edema, ascites, Hepatic encephalopathy&#xD;
  &#xD;
        Clinical evaluation&#xD;
  &#xD;
          -  Etiology of chronic liver disease (Baseline)&#xD;
  &#xD;
          -  Control of etiological factor (Baseline, 3 monthly) Alcohol - No relapse, if relapse -&#xD;
             severity HBV - on antivirals, HBV DNA -ve HCV - HCV RNA -ve Metabolic risk factors&#xD;
             control- DM, HT, weight etc.&#xD;
  &#xD;
          -  Severity of liver disease (Baseline, 3 monthly) MELD score, MELD-Na score, CTP score&#xD;
  &#xD;
          -  Complications (at 3 month, 6 month, 9 month, 12 month):&#xD;
  &#xD;
        Overt Hepatic Encephalopathy, Portal hypertension related bleed, clinical jaundice, ascites,&#xD;
        hyponatremia, Acute kidney injury, spontaneous bacterial peritonitis, Infections&#xD;
  &#xD;
        Laboratory parametres&#xD;
  &#xD;
          -  Baseline (at enrollment) - Blood : KFT, LFT, CBC, INR, AFP, TNF-a, IL-6, CRP, VWF, ADAM&#xD;
             TS 13 Imaging : USG abdomen, LSM, SSM, ECHO Hemodynamics : HVPG (not mandatory)&#xD;
  &#xD;
          -  At 3 and 6 month - Blood : KFT, LFT, CBC, INR Imaging : USG abdomen, LSM, SSM&#xD;
  &#xD;
          -  At 1 year (end of follow-up) Blood : KFT, LFT, CBC, INR, AFP, TNF-a, IL-6, CRP, VWF,&#xD;
             ADAM TS 13 Imaging : USG abdomen, LSM, SSM Hemodynamics : HVPG ( not mandatory)&#xD;
  &#xD;
             - STATISTICAL ANALYSIS:&#xD;
  &#xD;
          -  Data will be reported as mean + SD.&#xD;
  &#xD;
          -  Categorical variables will be compared using the chi-square test or Fisher exact test&#xD;
  &#xD;
          -  Normal continuous variables will be compared using the Student's t test&#xD;
  &#xD;
          -  Non normal continuous variables will be compared using the Mann-Whitney rank-sum test&#xD;
             (unpaired data) or the Wilcoxon test (paired data).&#xD;
  &#xD;
          -  The actuarial probability of survival will be calculated by the Kaplan-Meier method and&#xD;
             compared using the log-rank test.&#xD;
  &#xD;
          -  A Cox regression analysis will be performed to identify independent prognostic factors&#xD;
             for survival.&#xD;
  &#xD;
          -  Univariate and multivariate analysis will be used whenever applicable. - Adverse effects&#xD;
             Carvedilol - Bradycardia, hypotension, giddiness, diarrhea, insomnia, hyperglycemia,&#xD;
             weight gain, increased BUN, increased nonprotein nitrogen (NPN), increased cough,&#xD;
             abnormal vision.&#xD;
  &#xD;
        Pentoxiphylline - Abdominal discomfort, bloating, diarrhea, Dizziness, headache, flushing,&#xD;
        chest pain, arrhythmias, hypertension, dyspnea, tachycardia, and hypotension.&#xD;
  &#xD;
        - Stopping rule If primary end point achieved or any adverse event due to drug&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</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>Incidence of New onset clinical decompensation (any of overt HE, variceal bleed, clinical jaundice and ascites) at 1 year in two groups.</measure>
      <time_frame>1 year</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Precipitants, timing of new-onset decompensation at 6 months in two groups.</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality at 6 months</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Precipitants, timing of new-onset decompensation at 12 months in two groups</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality at 12 months in two groups.</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Liver stiffness measured by Fibroscan at 6 months</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Liver stiffness measured by Fibroscan at 12 months</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ESR at 6 months in both groups</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in CRP at 6 months in both groups</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in IL 6 at 6 months in both groups</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in TNF Alpha at 6 months in both groups</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Von Willebrand factor at 6 months in both groups</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ADAM TS 13 at 6 months in both groups</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ESR at 12 months in both groups.</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in CRP at 12 months in both groups</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in IL 6 at 12 months in both groups</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in TNF Alpha at 12 months in both groups</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Von Willebrand factor at 12 months in both groups</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ADAM TS 13 at 12 months in both groups</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dose of Pentoxifylline and Carvedilol at 6 months.</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dose of Pentoxifylline and Carvedilol at 12 months</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with change in CTP in both groups.</measure>
      <time_frame>3 month, 6 month, 9 month and at end of 1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with change in MELD score in both groups.</measure>
      <time_frame>3 month, 6 month, 9 month and at end of 1 year</time_frame>
      <description>MELD minimum value=6 and maximum value=40</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Hepatocellular carcinoma at 6 months between two groups.</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Hepatocellular carcinoma at 12 months between two groups.</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Portal vein thrombosis at 6 months between two groups.</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Portal vein thrombosis at 12 months between two groups.</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with adverse events in both the groups.</measure>
      <time_frame>6 months and 12 months</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Liver Cirrhosis</condition>
    <arm_group>
      <arm_group_label>Pentoxiphylline plus Carvedilol</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Pentoxiphylline plus Carvedilol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Carvedilol</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>PCarvedilol</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Carvedilol</intervention_name>
      <description>Carvedilol</description>
      <arm_group_label>Carvedilol</arm_group_label>
      <arm_group_label>Pentoxiphylline plus Carvedilol</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pentoxifylline</intervention_name>
      <description>Pentoxiphylline</description>
      <arm_group_label>Pentoxiphylline plus Carvedilol</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18-70 years&#xD;
  &#xD;
            2. Cirrhosis with prior clinical decompensation (ascites, Hepatic encephalopathy, Portal&#xD;
               Hypertension related bleed)&#xD;
  &#xD;
            3. No current clinical decompensation (for at least 1 year)&#xD;
  &#xD;
            4. CTP A at enrollment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. NASH - not on lifestyle modification&#xD;
  &#xD;
            2. Post TIPS/ BRTO/ SAE patients&#xD;
  &#xD;
            3. Post renal or liver transplantation&#xD;
  &#xD;
            4. History of CAD, ischemic cardiomyopathy, PVD, ventricular arrythmia&#xD;
  &#xD;
            5. Presence of clinical ascites, HE, Jaundice&#xD;
  &#xD;
            6. Last clinical decompensation within 1 year.&#xD;
  &#xD;
            7. Bilirubin &gt;2mg/dl, Albumin &lt;3g/dl&#xD;
  &#xD;
            8. Ongoing significant alcohol use&#xD;
  &#xD;
            9. Active HCV/HBV infection (Detectable HCV RNA/ HBV DNA)&#xD;
  &#xD;
           10. Prior Intolerance to carvedilol and hypersensitivity to Pentoxyfylline&#xD;
  &#xD;
           11. Use of Pentoxifylline within last 3 months&#xD;
  &#xD;
           12. Lack of informed consent&#xD;
  &#xD;
           13. Hepatocellular carcinoma / Portal vein thrombosis/ Budd Chiari Syndrome&#xD;
  &#xD;
           14. Non-cirrhotic portal hypertension&#xD;
  &#xD;
           15. Ongoing CAM/Hepatotoxic drug intake&#xD;
  &#xD;
           16. Known HIV infection&#xD;
  &#xD;
           17. Pregnant women&#xD;
  &#xD;
           18. HepatoPulmonary Syndrome&#xD;
  &#xD;
           19. Known Etiology of decomepnsation during follow up&#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_contact>
      <last_name>Dr Jaifrin Daniel, MD</last_name>
      <phone>01146300000</phone>
      <email>jdaniel.m07@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Institute of Liver &amp; Biliary Sciences.</name>
        <address>
          <city>New Delhi</city>
          <state>Delhi</state>
          <zip>110070</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr Jaifrin Daniel, MD</last_name>
        <phone>+91-011-46300000</phone>
        <email>jdaniel.m07@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</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>Liver Cirrhosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carvedilol</mesh_term>
      <mesh_term>Pentoxifylline</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041932
  org study id: ILBS-Cirrhosis-62
  nct id: NCT06041932
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cirrhotics with decompensation have increased risk of morbidity and mortality. There is
        increased portal pressure leading to decompensation. Carvedilol is a standard therapy given
        to cirrhotic patient with clinically significant portal hypertension to reduce portal
        pressure. Pentoxifylline is a nonspecific phosphodiesterase inhibitor with anti-inflammatory
        properties. It reduces portal hypertension, decreases lipopolysaccharide-induced liver
        injury, improves nonalcoholic steatohepatitis, prevents development of HRS in ascites and
        SAH, prevents hepatopulmonary syndrome. We want to study whether addition of pentoxifylline
        to carvediolol vs carvedilol monotherapy reduces the risk of mortality and further
        decompensation in cirrhotics with prior decompensation.
  -  Study population: Cirrhotic patients with prior decompensation at least 1 year ago
  
          -  Study design: Open label randomized controlled trial
  
          -  Sample size Assuming decompensation in Arm 1 as 25%, and 10% in Arm 2, alpha error- 5,
             power - 80, 160 patients, 10 % lost to follow up - 180, Each arm 90 patients.
  
          -  Intervention Arm 1 : Carvedilol Arm 2 : Pentoxiphylline plus Carvedilol
  
          -  Monitoring and assessment
  
        At enrollment:
  
          -  - Complete history and physical examination
  
          -  Prior ascites, Hepatic encephalopathy, acute variceal bleed.
  
          -  Time to prior decompensation
  
          -  Pattern and number of prior decompensation
  
          -  Prior spontaneous bacterial peritonitis, hydrothorax, Acute on chronic liver failure,
             acute kidney injury
  
          -  Use of Non selective beta blockers, norfloxaxin, rifaximin and albumin
  
          -  Recent herbal/drugs intake
  
          -  History of EVL or other endotherapy
  
          -  History of hypertension, diabetes mellitus
  
          -  Fever , signs of sepsis
  
          -  Examination- Sarcopenia, fraility, icterus, pedal edema
  
        At follow-up (at 3 month, 6 month, 9 month, 12 month): Physical (preferably)
  
        • Complete history and physical examination
  
          -  New onset ascites, Hepatic encephalopathy, acute variceal bleed, clinical Jaundice
  
          -  Time to new decompensation from enrollment
  
          -  Pattern and number of new decompensation
  
          -  Other complications - Spontaneous bacterial peritonitis, hydrothorax, Acute on chronic
             liver failure, acute kidney injury.
  
          -  Recent herbal/drugs intake
  
          -  History of EVL or other endotherapy
  
          -  Hypertension, Diabetes control
  
          -  Fever , signs of sepsis
  
          -  Examination- Sarcopenia, fraility, icterus, pedal edema, ascites, Hepatic encephalopathy
  
        Clinical evaluation
  
          -  Etiology of chronic liver disease (Baseline)
  
          -  Control of etiological factor (Baseline, 3 monthly) Alcohol - No relapse, if relapse -
             severity HBV - on antivirals, HBV DNA -ve HCV - HCV RNA -ve Metabolic risk factors
             control- DM, HT, weight etc.
  
          -  Severity of liver disease (Baseline, 3 monthly) MELD score, MELD-Na score, CTP score
  
          -  Complications (at 3 month, 6 month, 9 month, 12 month):
  
        Overt Hepatic Encephalopathy, Portal hypertension related bleed, clinical jaundice, ascites,
        hyponatremia, Acute kidney injury, spontaneous bacterial peritonitis, Infections
  
        Laboratory parametres
  
          -  Baseline (at enrollment) - Blood : KFT, LFT, CBC, INR, AFP, TNF-a, IL-6, CRP, VWF, ADAM
             TS 13 Imaging : USG abdomen, LSM, SSM, ECHO Hemodynamics : HVPG (not mandatory)
  
          -  At 3 and 6 month - Blood : KFT, LFT, CBC, INR Imaging : USG abdomen, LSM, SSM
  
          -  At 1 year (end of follow-up) Blood : KFT, LFT, CBC, INR, AFP, TNF-a, IL-6, CRP, VWF,
             ADAM TS 13 Imaging : USG abdomen, LSM, SSM Hemodynamics : HVPG ( not mandatory)
  
             - STATISTICAL ANALYSIS:
  
          -  Data will be reported as mean + SD.
  
          -  Categorical variables will be compared using the chi-square test or Fisher exact test
  
          -  Normal continuous variables will be compared using the Student's t test
  
          -  Non normal continuous variables will be compared using the Mann-Whitney rank-sum test
             (unpaired data) or the Wilcoxon test (paired data).
  
          -  The actuarial probability of survival will be calculated by the Kaplan-Meier method and
             compared using the log-rank test.
  
          -  A Cox regression analysis will be performed to identify independent prognostic factors
             for survival.
  
          -  Univariate and multivariate analysis will be used whenever applicable. - Adverse effects
             Carvedilol - Bradycardia, hypotension, giddiness, diarrhea, insomnia, hyperglycemia,
             weight gain, increased BUN, increased nonprotein nitrogen (NPN), increased cough,
             abnormal vision.
  
        Pentoxiphylline - Abdominal discomfort, bloating, diarrhea, Dizziness, headache, flushing,
        chest pain, arrhythmias, hypertension, dyspnea, tachycardia, and hypotension.
  
        - Stopping rule If primary end point achieved or any adverse event due to drug
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of New onset clinical decompensation (any of overt HE, variceal bleed, clinical jaundice and ascites) at 1 year in two groups.
  time frame: 1 year
  measure: Precipitants, timing of new-onset decompensation at 6 months in two groups.
  time frame: 6 months
  measure: Mortality at 6 months
  time frame: 6 months
  measure: Precipitants, timing of new-onset decompensation at 12 months in two groups
  time frame: 12 months
  measure: Mortality at 12 months in two groups.
  time frame: 12 months
  measure: Changes in Liver stiffness measured by Fibroscan at 6 months
  time frame: 6 months
  measure: Changes in Liver stiffness measured by Fibroscan at 12 months
  time frame: 12 months
  measure: Change in ESR at 6 months in both groups
  time frame: 6 months
  measure: Change in CRP at 6 months in both groups
  time frame: 6 months
  measure: Change in IL 6 at 6 months in both groups
  time frame: 6 months
  measure: Change in TNF Alpha at 6 months in both groups
  time frame: 6 months
  measure: Change in Von Willebrand factor at 6 months in both groups
  time frame: 6 months
  measure: Change in ADAM TS 13 at 6 months in both groups
  time frame: 6 months
  measure: Change in ESR at 12 months in both groups.
  time frame: 12 months
  measure: Change in CRP at 12 months in both groups
  time frame: 12 months
  measure: Change in IL 6 at 12 months in both groups
  time frame: 12 months
  measure: Change in TNF Alpha at 12 months in both groups
  time frame: 12 months
  measure: Change in Von Willebrand factor at 12 months in both groups
  time frame: 12 months
  measure: Change in ADAM TS 13 at 12 months in both groups
  time frame: 12 months
  measure: Dose of Pentoxifylline and Carvedilol at 6 months.
  time frame: 6 months
  measure: Dose of Pentoxifylline and Carvedilol at 12 months
  time frame: 12 months
  measure: Number of patients with change in CTP in both groups.
  time frame: 3 month, 6 month, 9 month and at end of 1 year
  measure: Number of patients with change in MELD score in both groups.
  time frame: 3 month, 6 month, 9 month and at end of 1 year
  description: MELD minimum value=6 and maximum value=40
  measure: Incidence of Hepatocellular carcinoma at 6 months between two groups.
  time frame: 6 months
  measure: Incidence of Hepatocellular carcinoma at 12 months between two groups.
  time frame: 12 months
  measure: Incidence of Portal vein thrombosis at 6 months between two groups.
  time frame: 6 months
  measure: Incidence of Portal vein thrombosis at 12 months between two groups.
  time frame: 12 months
  measure: Number of patients with adverse events in both the groups.
  time frame: 6 months and 12 months
  arm group label: Pentoxiphylline plus Carvedilol
  arm group type: Experimental
  description: Pentoxiphylline plus Carvedilol
  arm group label: Carvedilol
  arm group type: Active Comparator
  description: PCarvedilol
  intervention type: Drug
  intervention name: Carvedilol
  description: Carvedilol
  arm group label: Carvedilol
  arm group label: Pentoxiphylline plus Carvedilol
  intervention type: Drug
  intervention name: Pentoxifylline
  description: Pentoxiphylline
  arm group label: Pentoxiphylline plus Carvedilol
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Dr Jaifrin Daniel, MD
  phone: 01146300000
  email: jdaniel.m07@gmail.com
  facility: 
  contact: 
  country: India
  responsible party type: Sponsor
  mesh term: Liver Cirrhosis
  mesh term: Carvedilol
  mesh term: Pentoxifylline
  sharing ipd: No