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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 June 2018 |
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Main ID: |
ChiCTR1800016669 |
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Date of registration:
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2018-06-15 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury: A multi-center, randomized, double-blind, positive control, phase III clinical trial
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Scientific title:
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Efficacy and Safety of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury: A multi-center, randomized, double-blind, positive control, phase III clinical trial |
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Date of first enrolment:
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2009-12-01 |
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Target sample size:
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intervention group:360;control group:120; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=28340 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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III (Phase III study)
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Countries of recruitment
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China
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Contacts
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Name:
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Ning Ding
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Address:
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369 Yuzhou Road South, Haizhou District, Lianyungang, Jiangsu, China
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Telephone:
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+86 18538737790 |
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Email:
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694466576@qq.com |
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Affiliation:
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CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
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Name:
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Minde Zeng
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Address:
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145 Shandong Middle Road, Huangpu District, Shanghai, China
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Telephone:
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+86 021-63364118 |
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Email:
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694466576@qq.com |
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Affiliation:
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National Pharmaceutical Clinical Research Institute, Renji Hospital Affiliated to Medical School of Shanghai Jiaotong University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged 18-70 years;
2. RACUM =6;
3. ALTs =2ULN, but TBiL = 3 ULN;
4. Liver biochemical abnormalities duration of no more than three months;
5. Patients need to fully understand and sign the inform consent form.
Exclusion criteria: 1. The liver injury is caused by other diseases, such as virus hepatitis, alcohol and non-alcohol fatty liver disease or the autoimmune liver disease;
2. The patients with the acute hepatic failure or hepatic decompensation, such as hepatic encephalopathy, ascites, albumin is = 35g/L, prothrombin time is elongated more than 2 seconds compared to its normal range;
3. The value of the TBiL is > 3ULN;
4. The value of serum creatinine > 1.5ULN;
5. Patients who have severe organic diseases on heart, lungs, brain, kidney and gastrointestinal tract;
6. Patients who are taking the drugs that might interfere the trial;
7. Patients who are allergic or intolerant to the study drug;
8. Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis;
9. Patients who are compliant with protocol;
10. Women who are pregnant, breast-feeding or with childbearing potential;
11. Patients who have attended other clinical trials within 3 months;
12. Not appropriate to be included after assessing by the investigators.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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drug-induced liver injury
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Intervention(s)
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intervention group:Magnesium Isoglycyrrhizinate Injection;control group:tiopronin injection;
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Primary Outcome(s)
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level of glutamic-pyruvic transaminase;level of glutamic oxalacetic transaminase;level of total bilirubin;level of alkline phosphatase;
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Source(s) of Monetary Support
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CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
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Ethics review
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Status: Approved
Approval date: 30/11/2009
Contact:
Guanrong Fan
+86 021-58752345-3417
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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