Adverse Drug Events, Adverse Drug Reactions, Safety Surveillance, Severe Adverse Events, Severe Adverse Reactions
Conditions
Brief summary
This registry aims to monitor the safety of Qizhi Tongluo Capsules and to identify the potential risk factors for its adverse drug reactions.
Interventions
DRUGQizhi Tongluo Capsules
Qizhi Tongluo Capsule, a Chinese patent medicine composed of 26 Chinese herbs, has been approved by China Food and Drug Administration for treating recovery period of ischemic stroke (drug approval numbers: B20171001).
Sponsors
Shanxi Zhendong Pharmacy Co., Ltd
Zhong Wang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who use Qizhi Tongluo Capsules in the monitoring hospitals.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse drug reactions (ADR) to the Qizhi Tongluo Capsules | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of serious adverse drug event (SADE) to the Qizhi Tongluo Capsules | 3 years | — |
| Changes in biological indicators of patients with serious adverse events | 3 years | Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for liver function (ALT, AST, ALP, TBIL, DBIL) |
| The incidence of adverse drug event (ADE) to the Qizhi Tongluo Capsules | 3 years | — |
| The incidence of new ADRs to the Qizhi Tongluo Capsules | 3 years | — |
Countries
China
Contacts
Primary ContactZhong Wang
Outcome results
None listed