Back to resultsInfrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites
Primary Purpose
Liver Cirrhosis, Refractory Ascites
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Infrared ray heat treatment
conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis focused on measuring Infrared ray heat treatment, liver cirrhosis, refractory ascites
Eligibility 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
Sites / Locations
- The first people's hospital of FoshanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Conventional Treatment and Infrared ray heat treatment group
conventional treatment group
Arm Description
conventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine.
conventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine.
Outcomes
Primary Outcome Measures
ascites pressure
use the invasive pressure sensor to estimate the ascites pressure before and after the Infrared ray heat treatment.
Secondary Outcome Measures
Full Information
NCT ID
NCT01558895
First Posted
March 18, 2012
Last Updated
March 20, 2012
Sponsor
First People's Hospital of Foshan
1. Study Identification
Unique Protocol Identification Number
NCT01558895
Brief Title
Infrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites
Official Title
Infrared Ray Heat Treatment in Hepatic Area in Liver Cirrhosis Patients With Refractory Ascites
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First People's Hospital of Foshan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Refractory Ascites
Keywords
Infrared ray heat treatment, liver cirrhosis, refractory ascites
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional Treatment and Infrared ray heat treatment group
Arm Type
Experimental
Arm Description
conventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine.
Arm Title
conventional treatment group
Arm Type
Active Comparator
Arm Description
conventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine.
Intervention Type
Radiation
Intervention Name(s)
Infrared ray heat treatment
Intervention Description
Patients in experimental group accepted Infrared ray heat treatment in hepatic area for 30 minutes as well as conventional therapy.
Intervention Type
Other
Intervention Name(s)
conventional treatment
Intervention Description
Conventional treatment consists of antiviral drugs, lowering aminotransferase and jaundice medicine.
Primary Outcome Measure Information:
Title
ascites pressure
Description
use the invasive pressure sensor to estimate the ascites pressure before and after the Infrared ray heat treatment.
Time Frame
30 min
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yinong Ye, doctor
Organizational Affiliation
First People's Hospital of Foshan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first people's hospital of Foshan
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yinong Ye, doctor
Phone
13826065501
Email
yinongye@163.com
12. IPD Sharing Statement
Learn more about this trial
Infrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites
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