Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective registry study to surveil early liver injuries caused by Yangxue Shengfa Capsule (YXSF Capsule) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to YXSF Capsule.
The primary objectives of this study include:
(i) The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of YXSF 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 YXSF Capsule.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taking YXSF Capsule Group | The overall individuals taking YXSF Capsule and achieving the inclusion criteria. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of YXSF Capsule. | The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of YXSF Capsule. | participants will be followed duration intake of YXSF Capsule, an expected average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical features of early liver injuries caused by YXSF Capsule assessed by serum parameters of liver function. | Clinical features of early liver injuries caused by YXSF Capsule assessed by serum parameters of liver function, such as liver biochemistry. | participants will be followed duration intake of YXSF Capsule, an expected average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease progression of early liver injuries caused by YXSF Capsule, i.e. death, liver failure, chronic DILI, recovery. | Disease progression of early liver injuries caused by YXSF Capsule, i.e. death, liver failure, chronic DILI, recovery. | 8 weeks |
Inclusion Criteria:
Individuals in accordance with indications for YXSF Capsule, including xerasia, itchy scalp, alopecia areata, seborrheic dermatitis and alopecia;
The age range of 18 to 70 yearsï¼›
Individuals taking YXSF 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:
Not provided
Not provided
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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
serum, plasma, histology and urine
| D011041 | Poisoning |