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Table 2 Data collection

From: Systematic analysis of randomised controlled trials of Chinese herb medicine for non-alcoholic steatohepatitis (NASH): implications for future drug development and trial design

Data category

Content

Medication

Medication type

 Herbal formula, dosage form

 Single herb extract, dosage form

Herbs

 The specific materials in each formula

Clinical research design

Patient enrollment

 Source: single hospital, multiple hospital

 Characteristics: country, age, history of NASH, comorbidity, visit type

 Sample size

 Diagnostic criteria

Interventions

 Other intervention besides medication

 Time period: trial duration and follow-up period

Comparator

 Other intervention besides medication

 Time period: trial duration and follow-up period

Outcome measures

 Primary outcome: overall clinical efficacy rate, hepatic function outcomes, blood lipids profiles, Radiological response improvement

 Secondary outcome: TCMs syndrome scores, blood sugar, liver fat, indexes of inflammation and tumor necrosis factor, other indicators

 Efficacy evaluation criteria and results

 Adverse effects

Clinical research design

 Single-arm/two-arms/three-arms