Infrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 18, 2012
CompletedFirst Posted
Study publicly available on registry
March 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedMarch 21, 2012
March 1, 2012
1 year
March 18, 2012
March 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ascites pressure
use the invasive pressure sensor to estimate the ascites pressure before and after the Infrared ray heat treatment.
30 min
Study Arms (2)
Conventional Treatment and Infrared ray heat treatment group
EXPERIMENTALconventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine.
conventional treatment group
ACTIVE COMPARATORconventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine.
Interventions
Patients in experimental group accepted Infrared ray heat treatment in hepatic area for 30 minutes as well as conventional therapy.
Conventional treatment consists of antiviral drugs, lowering aminotransferase and jaundice medicine.
Eligibility Criteria
You may qualify if:
- Male
- aged 18\~60 years
- inpatient
- Diagnosed with liver cirrhosis and liver stubborn ascites.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The first people's hospital of Foshan
Foshan, Guangdong, 528000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yinong Ye, doctor
First People's Hospital of Foshan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chief
Study Record Dates
First Submitted
March 18, 2012
First Posted
March 20, 2012
Study Start
March 1, 2012
Primary Completion
March 1, 2013
Study Completion
April 1, 2013
Last Updated
March 21, 2012
Record last verified: 2012-03