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The purpose of this study is to investigate the safety, effective dosage and treatment of Magnesium Isolycyrrhizinate Injection to cure the acute drug-induced liver injury compared with the Tiopronin Injection.
The pharmacology research shows that Magnesium Isoglycyrrhizinate could significantly decrease the elevation of ALT and AST coursed by carbon tetrachloride, D-galactosamine and Thioacetamide. It could also significantly reduce the injury on the liver coursed by D-galacosamine and immunologic factors. Magnesium Isoglycyrrhizinate with strong anti-inflammatory effect could protect the liver cell and improve the liver function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm 1 | Experimental | lower dose: Magnesium Isoglycyrrhizinate injection 100mg OD for 4 weeks |
|
| arm 2 | Experimental | higher dose:Magnesium Isoglycyrrhizinate injection 200mg OD for 4 weeks. |
|
| Tiopronin Injection | Active Comparator | Tiopronin Injection 200mg OD for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Isoglycyrrhizinate Injection 100mg OD | Drug | Magnesium Isoglycyrrhizinate Injection 100mg OD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of ALT normalization at week 4 of treatment | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| rates of ALT normalization at weeks 1, 2, and 3 of treatment | 3 weeks | |
| change of ALT at weeks 1, 2, 3 and 4 of treatment; | 4 weeks | |
| change of AST at weeks 1, 2, 3 and 4 of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
ULN=Upper Limited Normal
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| Name | Affiliation | Role |
|---|---|---|
| Minde Zeng, MD | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chest Hospital, Capital Medical University | Beijing | Beijing Municipality | China | |||
| Nanjing Pulmonary Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9303497 | Background | Maria VA, Victorino RM. Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis. Hepatology. 1997 Sep;26(3):664-9. doi: 10.1002/hep.510260319. | |
| 16496329 | Background | Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology. 2006 Mar;43(3):618-31. doi: 10.1002/hep.21095. |
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| Magnesium Isoglycyrrhizinate Injection 200mg OD | Drug | Magnesium Isoglycyrrhizinate Injection 200mg OD for 4 weeks |
|
|
| Tiopronin Injection | Drug | Tiopronin Injection 200mg OD |
|
|
| 4 weeks |
| Nanjing |
| Jiangsu |
| China |
| 85 Hospital of People's Liberation Army | Shanghai | Shanghai Municipality | China |
| Renji Hospital Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | China |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | China |
| Integrated Chinese and Western Medicine Hospital of Zhejiang Province | Hangzhou | Zhejiang | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D056486 | Chemical and Drug Induced Liver Injury |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011041 | Poisoning |
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| ID | Term |
|---|---|
| C521270 | 18alpha,20beta-hydroxy-11-oxo-norolean-12-en-3beta-yl-2-O-beta-D-glucopyranurosyl-alpha-D-glucopyranosiduronate magnesium tetrahydrate |
| D036881 | Long-Term Synaptic Depression |
| D008625 | Tiopronin |
| ID | Term |
|---|---|
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D034442 | N-substituted Glycines |
| D005998 | Glycine |
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