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Infrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites

This study is currently recruiting participants.
Verified March 2012 by First People's Hospital of Foshan
Sponsor:
Information provided by (Responsible Party):
Yinong Ye, First People's Hospital of Foshan
ClinicalTrials.gov Identifier:
NCT01558895
First received: March 18, 2012
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

The objective of this study is to evaluate the therapeutic efficacy of Infrared ray heat treatment in hepatic area in cirrhosis patients with refractory ascites. The evaluation of the efficacy includes the ascites pressure, portal vein velocity，SAAG before and after the treatment. Clinical symptoms were also observed simultaneously.


Condition Intervention Phase
Liver Cirrhosis
Refractory Ascites
 Radiation: Infrared ray heat treatment
Other: conventional treatment
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Infrared Ray Heat Treatment in Hepatic Area in Liver Cirrhosis Patients With Refractory Ascites

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by First People's Hospital of Foshan:

Primary Outcome Measures:
  • ascites pressure [ Time Frame: 30 min ] [ Designated as safety issue: Yes ]
    use the invasive pressure sensor to estimate the ascites pressure before and after the Infrared ray heat treatment.


Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional Treatment and Infrared ray heat treatment group
conventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine.
 Radiation: Infrared ray heat treatment
Patients in experimental group accepted Infrared ray heat treatment in hepatic area for 30 minutes as well as conventional therapy.
Active Comparator: conventional treatment group
conventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine.
 Other: conventional treatment
Conventional treatment consists of antiviral drugs, lowering aminotransferase and jaundice medicine.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male
  • aged 18~60 years
  • inpatient
  • Diagnosed with liver cirrhosis and liver stubborn ascites.

Exclusion Criteria:

  • Severe problems in other vital organs(e.g.the heart,renal or lungs).
  • combined with malignant tumour.
  • combined with endocrine diseases.
  • combined with high fever.
  • infected with the AIDS virus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558895

Locations
China, Guangdong
The first people`s hospital of Foshan Recruiting
Foshan, Guangdong, China, 528000
Contact: Yinong Ye, doctor     13826065501     yinongye@163.com    
Sponsors and Collaborators
First People's Hospital of Foshan
Investigators
Principal Investigator: Yinong Ye, doctor The First People`s Hospital of Foshan
  More Information

No publications provided

Responsible Party: Yinong Ye, Professor and Chief, First People's Hospital of Foshan
ClinicalTrials.gov Identifier: NCT01558895     History of Changes
Other Study ID Numbers: FS-001
Study First Received: March 18, 2012
Last Updated: March 20, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by First People's Hospital of Foshan:
Infrared ray heat treatment
liver cirrhosis
refractory ascites

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
 Digestive System Diseases
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013