Table 6 Clinical research design status
Clinical research design Items | Including types | Trials number | Participants number |
|---|---|---|---|
Participants enrollment | |||
Inclusion criteria | Including: diagnosis criteria, biochemical indexes, age, medication history, radiological examination, good adherence, comorbidities, liver histology test, no mention of inclusion criteria, history of NASH, not participating in other clinical trials, alcohol intake requirements | 112 | 10,573 |
Exclusion criteria | Including: comorbidities, fatty liver or liver disease with an established cause, pregnancy or breastfeeding | 91 | 8824 |
Allergy, age, analogous therapeutic medication history, relevant drug usage history that might have an impact on the trial, non-cooperation | |||
Excessive alcohol intake, genetic metabolic conditions, participation in other RCT, liver enzymes, poor adherence, drug abuse | |||
Not specific the exclusion criteria | 21 | 1749 | |
Diagnostic criteria | Integration medicine and western medicine criteria | 75 | 7622 |
Western medicine diagnostic criteria | 24 | 2036 | |
Integration medicine criteria | 4 | 350 | |
Not mentioned | 9 | 565 | |
Country | China | 108 | 10,341 |
Iran | 3 | 224 | |
Japan | 1 | 8 | |
Age | Range: 16–76 years old | 107 | 10,070 |
History of NASH | Range: 3 months–16 years from | 62 | 5806 |
Not mentioned | 50 | 4767 | |
Visit type | Outpatients | 47 | 4579 |
Inpatients | 4 | 326 | |
Inpatients or outpatients | 21 | 1682 | |
Not mentioned: 40 trials | |||
Comorbidity | Obesity | 2 | 169 |
Type II diabetes | 1 | 62 | |
COPD | 1 | 60 | |
Hyperuricemia | 1 | 59 | |
Chronic hepatitis B | 1 | 68 | |
Glycometabolic disease (1 trial) | 1 | 119 | |
Source | Single hospital | 81 | 8782 |
Multiple hospitals | 13 | 1791 | |
Size | Mean: 94 ± 31 patients | \ | \ |
Range: 8 to 220 patients | \ | \ | |
Interventions | |||
Medication | Only TCMs | 73 | 7347 |
TCMs combining with other medicine | 39 | 3226 | |
Other interventions | Exercise and/or diet | 80 | 7341 |
Comparator | |||
Medication | Chemical medicine | 92 | 8691 |
Chinese patent medicine | 6 | 529 | |
TCMs and Chemical medicine | 2 | 219 | |
Placebo | 7 | 468 | |
Exercise/diet | 3 | 414 | |
Other interventions | Basic treatment | 1 | 32 |
No comparator | Self-comparison | 1 | 220 |
Outcome | Primary outcome | \ | \ |
Overall clinical efficacy rate | |||
Hepatic function outcomes | |||
Blood lipid profiles | |||
Radiological response improvement | |||
Secondary outcome | \ | \ | |
TCMs syndrome scores efficacy rate | |||
Blood sugar | |||
Liver fat, Indexes of inflammation and tumor necrosis factor | |||
Other indicators | |||
Adverse effect | 51 | 5229 | |
Research design | Single-arm | 1 | |
Two-arms | 110 | ||
Three-arms | 1 | ||
Time period < 6 months | 90 | 8130 | |
Time period = 6 months | 21 | 2375 | |
Time period = 12 months | 1 | 68 |