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NCT01558895 Clinical Trial

Infrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01558895
Other study ID # FS-001
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received March 18, 2012
Last updated March 20, 2012
Start date March 2012
Est. completion date April 2013

Study information
Verified date March 2012
Source First People's Hospital of Foshan
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date April 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.
Other:
• conventional treatment
Conventional treatment consists of antiviral drugs, lowering aminotransferase and jaundice medicine.

Locations
Country Name City State
China The first people`s hospital of Foshan Foshan Guangdong

Sponsors (1)
Lead Sponsor Collaborator
First People's Hospital of Foshan

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary ascites pressure use the invasive pressure sensor to estimate the ascites pressure before and after the Infrared ray heat treatment. 30 min Yes
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