Adverse Drug Events Clinical Trial
Official title:
Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.
NCT number | NCT04479553 |
Other study ID # | QZTL-V1.0 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 17, 2020 |
Est. completion date | December 2023 |
This registry aims to monitor the safety of Qizhi Tongluo Capsules and to identify the potential risk factors for its adverse drug reactions.
Status | Recruiting |
Enrollment | 30000 |
Est. completion date | December 2023 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients who use Qizhi Tongluo Capsules in the monitoring hospitals. Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Hospital of Changzhi Institute of traditional Chinese Medicine | Changzhi | Shanxi |
China | Ningming County Hospital of Chinese Medicine | Changzuo | Guangxi |
China | Fangchenggang City Hospital of Chinese Medicine | Fangchenggang | Guangxi |
China | The Second Affiliated Hospital of Shandong University of Chinese Medicine | Jinan | Shandong |
China | Luohe Hospital of traditional Chinese Medicine | Luohe | Henan |
China | Long'an County Hospital of Chinese Medicine | Nanning | Guangxi |
China | Shanglin County Hospital of Chinese Medicine | Nanning | Guangxi |
China | The First Affiliated Hospital of Guangxi University of Chinese Medicine | Nanning | Guangxi |
China | The First Affiliated Hospital of Nanyang Medical College | Nanyang | Henan |
China | The Second Affiliated Hospital of Nanyang Medical College | Nanyang | Henan |
China | The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan |
China | Affiliated Hospital of Yanbian University | Yanbian | Jilin |
China | The First Affiliated Hospital of Henan University of traditional Chinese Medicine | Zhengzhou | Henan |
China | The Third Affiliated Hospital of Henan University of traditional Chinese Medicine | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Zhong Wang | Shanxi Zhendong Pharmacy Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of adverse drug reactions (ADR) to the Qizhi Tongluo Capsules | 3 years | ||
Secondary | The incidence of adverse drug event (ADE) to the Qizhi Tongluo Capsules | 3 years | ||
Secondary | The incidence of new ADRs to the Qizhi Tongluo Capsules | 3 years | ||
Secondary | The incidence of serious adverse drug event (SADE) to the Qizhi Tongluo Capsules | 3 years | ||
Secondary | Changes in biological indicators of patients with serious adverse events | Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for liver function (ALT, AST, ALP, TBIL, DBIL) | 3 years | |
Secondary | Changes in biological indicators of patients with serious adverse events | Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for renal function (BUN, SCr, UA) | 3 years | |
Secondary | Changes in biological indicators of patients with serious adverse events | Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for immune indicators (IgA, IgE, T-lymphocyte, B lymphocyte, cell surface antigen, serum histamine concentration and complement). | 3 years |
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