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Infrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Yinong Ye, First People's Hospital of Foshan.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01558895
First Posted: March 20, 2012
Last Update Posted: March 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yinong Ye, First People's Hospital of Foshan
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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

Primary Outcome Measures:
  • ascites pressure [ Time Frame: 30 min ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 18, 2012
First Posted: March 20, 2012
Last Update Posted: March 21, 2012
Last Verified: March 2012

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

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