Liver CirrhosisPhase 2/3NCT01558895
Infrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites
A Phase 2/3 study testing Infrared ray heat treatment and conventional treatment in people with Liver Cirrhosis and Refractory Ascites, run by First People's Hospital of Foshan at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis, Refractory Ascites
- What is being tested?
- Infrared ray heat treatment and conventional treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Apr 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- aged 18~60 years
- inpatient
- Diagnosed with liver cirrhosis and liver stubborn ascites.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first people's hospital of Foshan
Foshan, Guangdong, 528000
Yinong Ye, doctor, 13826065501, yinongye@163.com
About this study
Official title: 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.
- Conditions
- Liver Cirrhosis, Refractory Ascites
- Being tested
- Infrared ray heat treatment, conventional treatment
- Keywords
- Infrared ray heat treatment, liver cirrhosis, refractory ascites
- Medical subject headings
- Liver Cirrhosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared ray heat treatmentRadiation
Patients in experimental group accepted Infrared ray heat treatment in hepatic area for 30 minutes as well as conventional therapy.
conventional treatmentOther
Conventional treatment consists of antiviral drugs, lowering aminotransferase and jaundice medicine.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment and Infrared ray heat treatment group | Experimental | conventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine. Receives: Radiation: Infrared ray heat treatment |
| conventional treatment group | Active comparator | conventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine. Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ascites pressure
use the invasive pressure sensor to estimate the ascites pressure before and after the Infrared ray heat treatment.
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Foshan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinong Ye, First People's Hospital of Foshan
- Investigators
- Yinong Ye, doctor, Principal investigator, First People's Hospital of Foshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558895
- Sponsor's protocol ID
- FS-001
- Status last verified
- Mar 2012
- First submitted
- 18 Mar 2012
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infrared Ray Heat Treatment in Hepatic Area in Liver Cirrhosis Patients With Refractory Ascites
- ClinicalTrials.gov ID
- NCT01558895
- Acronym / sponsor ID
- FS-001
- Conditions
- Liver Cirrhosis, Refractory Ascites
- Keywords
- Infrared ray heat treatment, liver cirrhosis, refractory ascites
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First People's Hospital of FoshanUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment and Infrared ray heat treatment group | Experimental | Radiation: Infrared ray heat treatmentconventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine. |
| conventional treatment group | Active comparator | Other: conventional treatmentconventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- aged 18~60 years
- inpatient
- Diagnosed with liver cirrhosis and liver stubborn ascites.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared ray heat treatmentPatients in experimental group accepted Infrared ray heat treatment in hepatic area for 30 minutes as well as conventional therapy. | Radiation | Conventional Treatment and Infrared ray heat treatment group |
| conventional treatmentConventional treatment consists of antiviral drugs, lowering aminotransferase and jaundice medicine. | Other | conventional treatment group |
Primary outcome
ascites pressure
Time frame: 30 min
use the invasive pressure sensor to estimate the ascites pressure before and after the Infrared ray heat treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yinong Ye, doctor principal investigator
First People's Hospital of Foshan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Infrared ray heat treatment and conventional treatment in people with Liver Cirrhosis and Refractory Ascites, run by First People's Hospital of Foshan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ascites pressure (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2012.