Clinical trial NCT04479553: Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.
Official title: Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Safety Surveillance
Adverse Drug Events
Adverse Drug Reactions
Severe Adverse Events
Severe Adverse Reactions
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shanxi Zhendong Pharmacy Co., Ltd
First posted: 2020-07-21
Enrollment: 30000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who use Qizhi Tongluo Capsules in the monitoring hospitals.

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.


Eligibility criteria: Inclusion Criteria:

* Patients who use Qizhi Tongluo Capsules in the monitoring hospitals.

Exclusion Criteria:

* None

Primary outcomes:
measure: The incidence of adverse drug reactions (ADR) to the Qizhi Tongluo Capsules
timeFrame: 3 years
Secondary outcomes:
measure: The incidence of adverse drug event (ADE) to the Qizhi Tongluo Capsules
timeFrame: 3 years
measure: The incidence of new ADRs to the Qizhi Tongluo Capsules
timeFrame: 3 years
measure: The incidence of serious adverse drug event (SADE) to the Qizhi Tongluo Capsules
timeFrame: 3 years
measure: Changes in biological indicators of patients with serious adverse events
timeFrame: 3 years
measure: Changes in biological indicators of patients with serious adverse events
timeFrame: 3 years
measure: Changes in biological indicators of patients with serious adverse events
timeFrame: 3 years
Other outcomes:
Locations:
city: Changzuo
country: China
facility: Ningming County Hospital of Chinese Medicine
state: Guangxi
city: Fangchenggang
country: China
facility: Fangchenggang City Hospital of Chinese Medicine
state: Guangxi
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi University of Chinese Medicine
state: Guangxi
city: Nanning
country: China
facility: Shanglin County Hospital of Chinese Medicine
state: Guangxi
city: Nanning
country: China
facility: Long'an County Hospital of Chinese Medicine
state: Guangxi
city: Luohe
country: China
facility: Luohe Hospital of traditional Chinese Medicine
state: Henan
city: Nanyang
country: China
facility: The First Affiliated Hospital of Nanyang Medical College
state: Henan
city: Nanyang
country: China
facility: The Second Affiliated Hospital of Nanyang Medical College
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of traditional Chinese Medicine
state: Henan
city: Zhengzhou
country: China
facility: The Third Affiliated Hospital of Henan University of traditional Chinese Medicine
state: Henan
city: Yanbian
country: China
facility: Affiliated Hospital of Yanbian University
state: Jilin
city: Jinan
country: China
facility: The Second Affiliated Hospital of Shandong University of Chinese Medicine
state: Shandong
city: Changzhi
country: China
facility: Affiliated Hospital of Changzhi Institute of traditional Chinese Medicine
state: Shanxi
Study officials:
References: