Infrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites

March 20, 2012 updated by: Yinong Ye, First People's Hospital of Foshan

Infrared Ray Heat Treatment in Hepatic Area in Liver Cirrhosis Patients With Refractory Ascites

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Recruiting
        • The First People's Hospital of Foshan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ascites pressure
Time Frame: 30 min
use the invasive pressure sensor to estimate the ascites pressure before and after the Infrared ray heat treatment.
30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Foshan

Investigators

  • Principal Investigator: Yinong Ye, doctor, First People's Hospital of Foshan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ANTICIPATED)

March 1, 2013

Study Completion (ANTICIPATED)

April 1, 2013

Study Registration Dates

First Submitted

March 18, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (ESTIMATE)

March 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 21, 2012

Last Update Submitted That Met QC Criteria

March 20, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Cirrhosis

Clinical Trials on Infrared ray heat treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe