Liver DamageNCT02329314
The Evaluation of Glycyrrhizic Acid's Pesticide Effect in Treating Liver Damage (Retrospective Study）
An observational study of Liver Damage, run by ShuGuang Hospital at 1 site in China.
Trial summary
Collect the details about hepatic dysfunctional patients induced by various etiology who have a usage of Glycyrrhizic Acid, then arrange and analyse the data to evaluate the clinical curative effect of glycyrrhizic acid. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Damage
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Jun 2016
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This experiment will screen and collect qualified casefrom medical records in Shuguang Hospital.to collect the patients with liver injury in clinic, including (1) conforms to ALT>1.5 times the normal value or >70IU/L, age 18 to 70 years of age, sex is not limited; (2) patients with viral hepatitis or cirrhosis of the liver, or autoimmune liver disease, or schistosomiasis, or drug-induced liver damage, or for other reasons clear or unclear leading to abnormal liver function ; (3) except for tumor patients.
Who may be able to join
- conforms to ALT>1.5 times the normal value or >70IU/L, age 18 to 70 years of age, sex is not limited;
- patients with viral hepatitis or cirrhosis of the liver, or autoimmune liver disease, or schistosomiasis, or drug-induced liver damage, or for other reasons clear or unclear leading to abnormal liver function ;
Who cannot join
- patients with tumor;
- pregnant or lactating women, and pregnancy may not take effective contraceptive measures;
- complicated with serious heart, lung, gallbladder, kidney, endocrine, hematopoietic system and mental disease;
- the researchers think that should not be selected for this test.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shuguang Hospital
Shanghai, Shanghai Municipality
Sun Mingyu, professor, 86-21-20256526, mysun248@hotmail.com
About this study
Collect the details about hepatic dysfunctional patients induced by various etiology who have a usage of Glycyrrhizic Acid, then arrange and analyse the data to evaluate the clinical curative effect of glycyrrhizic acid.
Read the detailed description
This experiment will screen and collect qualified cases from medical records in Shuguang Hospital.to collect the patients with liver injury in clinic, including (1) conforms to ALT>1.5 times the normal value or >70 IU/L, age 18 to 70 years of age, sex is not limited; (2) patients with viral hepatitis or cirrhosis of the liver, or autoimmune liver disease, or schistosomiasis, or drug-induced liver damage, or for other reasons clear or unclear leading to abnormal liver function ; (3) except for tumor patients. The index of liver function such as ALT, AST, Alb, et al are detected respectively before and after preventive treatment of the glycyrrhizic acid for liver injury ,and through the synthesizing of the single sample difference t test and clinical practice to analyze the clinical efficacy of glycyrrhizin intervention treatment of hepatic injury
- Conditions
- Liver Damage
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical indexes measured before and after the interference
to measure biochemical indexes such as ALT, AST, ALB, TBiL, et al before and after the interference with Glycyrrhizic Acid
Measured: 1-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DamageStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShuGuang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Wu, ShuGuang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329314
- Sponsor's protocol ID
- 2014-365-61-01
- Status last verified
- Dec 2014
- First submitted
- 26 Dec 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Glycyrrhizic Acid's Pesticide Effect in Treating Liver Damage (Retrospective Study）
- ClinicalTrials.gov ID
- NCT02329314
- Acronym / sponsor ID
- 2014-365-61-01
- Conditions
- Liver Damage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ShuGuang HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 31 Dec 2014 (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.
Collect the details about hepatic dysfunctional patients induced by various etiology who have a usage of Glycyrrhizic Acid, then arrange and analyse the data to evaluate the clinical curative effect of glycyrrhizic acid.
Detailed description
This experiment will screen and collect qualified cases from medical records in Shuguang Hospital.to collect the patients with liver injury in clinic, including (1) conforms to ALT>1.5 times the normal value or >70 IU/L, age 18 to 70 years of age, sex is not limited; (2) patients with viral hepatitis or cirrhosis of the liver, or autoimmune liver disease, or schistosomiasis, or drug-induced liver damage, or for other reasons clear or unclear leading to abnormal liver function ; (3) except for tumor patients. The index of liver function such as ALT, AST, Alb, et al are detected respectively before and after preventive treatment of the glycyrrhizic acid for liver injury ,and through the synthesizing of the single sample difference t test and clinical practice to analyze the clinical efficacy of glycyrrhizin intervention treatment of hepatic injury
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This experiment will screen and collect qualified casefrom medical records in Shuguang Hospital.to collect the patients with liver injury in clinic, including (1) conforms to ALT>1.5 times the normal value or >70IU/L, age 18 to 70 years of age, sex is not limited; (2) patients with viral hepatitis or cirrhosis of the liver, or autoimmune liver disease, or schistosomiasis, or drug-induced liver damage, or for other reasons clear or unclear leading to abnormal liver function ; (3) except for tumor patients.
Key inclusion criteria (2 listed)
- conforms to ALT>1.5 times the normal value or >70IU/L, age 18 to 70 years of age, sex is not limited;
- patients with viral hepatitis or cirrhosis of the liver, or autoimmune liver disease, or schistosomiasis, or drug-induced liver damage, or for other reasons clear or unclear leading to abnormal liver function ;
Key exclusion criteria (4 listed)
- patients with tumor;
- pregnant or lactating women, and pregnancy may not take effective contraceptive measures;
- complicated with serious heart, lung, gallbladder, kidney, endocrine, hematopoietic system and mental disease;
- the researchers think that should not be selected for this test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biochemical indexes measured before and after the interference
Time frame: 1-4 weeks
to measure biochemical indexes such as ALT, AST, ALB, TBiL, et al before and after the interference with Glycyrrhizic Acid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Damage, run by ShuGuang Hospital 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 2 inclusion and 4 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 31 Dec 2014. 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.
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?
Contact Wu Chao, postgraduate (15221095202, 15221095202@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical indexes measured before and after the interference (time frame: 1-4 weeks). 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 31 Dec 2014.