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This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao Capsule (XLGB Capsule) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to XLGB Capsule.
The primary objectives of this study include:
(i) The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Capsule; (ii) The record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) The specimen collection of surveiled individuals. (iv) The attempt to establish a predictive model to screen susceptibilities to XLGB Capsule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The individuals taking XLGB Capsule | The overall individuals taking XLGB Capsule with recommended dosage and achieving the inclusion criteria. |
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| Measure | Description | Time Frame |
|---|---|---|
| The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Capsule. | The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Capsule. | participants will be followed duration intake of XLGB Capsule, an expected average within 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical features of early liver injuries caused by XLGB Capsule assessed by serum parameters of liver function. | Clinical features of early liver injuries caused by XLGB Capsule assessed by serum parameters of liver function. | participants will be followed duration intake of XLGB Capsule, an expected average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease progression of early liver injuries caused by XLGB Capsule, i.e. death, liver failure, chronic DILI, recovery. | Disease progression of early liver injuries caused by XLGB Capsule, i.e. death, liver failure, chronic DILI, recovery. | 8 weeks |
Inclusion Criteria:
Individuals in accordance with indications for XLGB Capsule, including osteoarthritis, and lumbar muscle strain;
The age range of 18 to 70 yearsï¼›
Individuals taking XLGB Capsule over 2 weeks;
Abnormalities of serum liver biochemistry achieving one of the criteria as follows:
(i) alanine aminotransaminase (ALT) or aspartate transaminase (AST) ≥2 folds of upper limit of normal (ULN); (ii) total bilirubin (TBiL) ≥ 2 ULN; (iii) alkaline phosphatase (ALP) ≥ 2 ULN;
Individuals can provide informed consent form.
Exclusion Criteria:
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community sample and primary care clinic.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao-he Xiao | Contact | +86 66933322 | pharmacy302xxh@126.com | |
| Jia-bo Wang | Contact | +86 66933323 | pharm_sci@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao-he Xiao | 302 Military Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 302 Military Hospital | Beijing | Beijing Municipality | 100039 | China |
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| 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 |
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serum, plasma, histology and urine.
| D011041 | Poisoning |