adverse drug reaction
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients whose doctor's prescription contains varieties of TCM granules of key concern or there are situations of unreasonable use of TCM granules;
Exclusion criteria
Exclusion criteria: (1) The patient was not taking TCM granules; (2) The patients had poor compliance and could not be followed up to the occurrence of adverse events; (3) The patient has participated in this study before; (4) Women of childbearing age who were pregnant nursing planning to become pregnant or unable to use effective contraception during the study period and men of childbearing age who were unable or unwilling to use effective contraception.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The occurrence of serious adverse event;Occurrence of adverse drug reactions judged to be possibly relevant probably relevant and definitely relevant;Occurrence of serious adverse drug reactions judged to be possibly relevant probably relevant and definitely relevant;Occurrence of adverse events / adverse reactions of other formula granules used in combination with focused varieties Situation; | — |
Primary
| Measure | Time frame |
|---|---|
| The occurrence of adverse events; | — |
Countries
China
Contacts
First Affiliated Hospital of Guangzhou Medical University