Efficacy of Pentoxifylline and Rifaximin Combination in Pentoxifylline Refractory Clinical and Subclinical Hepatopulmonary Syndrome
NCT01676597 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2013-12-17
Summary
* The study will be a prospective open labelled double blinded randomized controlled study.
* The study will be conducted on patients admitted to Department of Hepatology from 2012 to 2014 at Institute of Liver and Biliary Sciences, New Delhi
* Patients diagnosed as having clinical or subclinical hepatopulmonary syndrome will be started on oral pentoxifylline therapy 400 mg thrice daily for 12 weeks.
* Patients not responding to this therapy will be given divided into 2 arms with one arm receiving additional Tab Rifaximin 400 mg thrice daily or placebo for 12 weeks.
Conditions
- Hepatopulmonary Syndrome
Interventions
- DRUG
-
pentoxifylline and rifaximin
Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks
- DRUG
-
Pentoxifylline and placebo
Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks
Sponsors & Collaborators
-
Institute of Liver and Biliary Sciences, India
lead OTHER
Principal Investigators
-
Dr Naveen Kumar, MD · Institute of Liver and Biliary Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-09-30
- Primary Completion
- 2014-09-30
- Completion
- 2014-09-30
Countries
- India
Study Locations
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