Item | Screening visit day | 1st month | 2nd month | 3rd month | 4th month | 5th month | 6th month | 7th month | 8th month | 9th month | 10th month | 11th month |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Informed consent | √ |  |  |  |  |  |  |  |  |  |  |  |
Basic informationa | √ |  |  |  |  |  |  |  |  |  |  |  |
Epidemiological investigationb | √ |  |  |  |  |  |  |  |  |  |  |  |
Underlying diseasec | √ |  |  |  |  |  |  |  |  |  |  |  |
Allocation | √ |  |  |  |  |  |  |  |  |  |  |  |
Intervention |  | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
 Chemotherapeutic drugs + No.1 + No.3 compound |  | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
 Chemotherapeutic drugs + No. 1 placebo + No. 3 placebo |  | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
 Chemotherapeutic drugs + No. 2 + No. 4 compound |  | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
 Chemotherapeutic drugs + No. 2 placebo + No. 4 placebo |  | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
Outcome measure | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Cure rate |  |  |  |  |  |  |  |  |  |  |  | √ |
 Time to sputum culture conversion |  |  |  |  |  |  |  |  |  |  |  | √ |
 Lesion absorption rate | √ |  |  | √ |  |  | √ |  |  |  |  | √ |
 Cavity closure rate | √ |  |  | √ |  |  | √ |  |  |  |  | √ |
The effect rate of TCM syndrome | √ |  |  | √ |  |  | √ |  |  |  |  | √ |
Clinical manifestationsa | √ | √ | √ | √ | √ | √ | √ | √ | √ |  | √ | √ |
Chest CT | √ |  |  | √ |  |  | √ |  |  |  |  | √ |
Culture of M.tba,b | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
Acid-Fast Bacilli sputum smeard,e | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
DSTd,e | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
Safety assessments | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 Physical examinationd | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
 Vital signsd,f | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
 Physical examinationd | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
 Complete ophthalmological examinationd | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
 Blood routined | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
 Urine routined | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
 Liver functiond | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
 Kidney functiond | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
 Electrocardiogramd | √ | √ |  | √ |  |  |  |  |  |  |  | √ |
 Blood glucose | √ | √ |  | √ |  |  |  |  |  |  |  | √ |
 Adverse events recordedd,g | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |