Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.
1 other identifier
observational
30,000
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2020
CompletedFirst Posted
Study publicly available on registry
July 21, 2020
CompletedStudy Start
First participant enrolled
August 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedNovember 15, 2022
November 1, 2022
3 years
July 17, 2020
November 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of adverse drug reactions (ADR) to the Qizhi Tongluo Capsules
3 years
Secondary Outcomes (6)
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
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
Changes in biological indicators of patients with serious adverse events
3 years
- +1 more secondary outcomes
Study Arms (1)
Qizhi Tongluo Capsules
Qizhi Tongluo Capsules will be given to the patients, and the investigators will record all the information including ADR, application of Qizhi Tongluo Capsules and the combined medications, etc.
Interventions
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).
Eligibility Criteria
Patients who use Qizhi Tongluo Capsules in the monitoring hospitals.
You may qualify if:
- Patients who use Qizhi Tongluo Capsules in the monitoring hospitals.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhong Wanglead
- Shanxi Zhendong Pharmacy Co., Ltdcollaborator
Study Sites (14)
Ningming County Hospital of Chinese Medicine
Changzuo, Guangxi, 532500, China
Fangchenggang City Hospital of Chinese Medicine
Fangchenggang, Guangxi, 538021, China
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, 530023, China
Shanglin County Hospital of Chinese Medicine
Nanning, Guangxi, 530500, China
Long'an County Hospital of Chinese Medicine
Nanning, Guangxi, 532799, China
Luohe Hospital of traditional Chinese Medicine
Luohe, Henan, 462000, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473000, China
The Second Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473000, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453199, China
The First Affiliated Hospital of Henan University of traditional Chinese Medicine
Zhengzhou, Henan, 450003, China
The Third Affiliated Hospital of Henan University of traditional Chinese Medicine
Zhengzhou, Henan, 450003, China
Affiliated Hospital of Yanbian University
Yanbian, Jilin, 133000, China
The Second Affiliated Hospital of Shandong University of Chinese Medicine
Jinan, Shandong, 250001, China
Affiliated Hospital of Changzhi Institute of traditional Chinese Medicine
Changzhi, Shanxi, 046000, China
Biospecimen
1. The blood routine, urine routine, and stool routine before and after medication need to be obtained in the patients with adverse events 2. The level of the liver functional indicators (including ALT,AST,ALP,TBIL,DBIL) the renal functional indicators (including BUN,SCr,UA) and the immune indicators (including IgA，IgE,the counts of T lymphocyte and B lymphocyte,CD3，CD4，CD8，CD20,serum histamine concentration,C3,C4) should be obtained in patients with serious adverse events and suspicious unexpected serious adverse reactions.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 17, 2020
First Posted
July 21, 2020
Study Start
August 17, 2020
Primary Completion
September 1, 2023
Study Completion
December 1, 2023
Last Updated
November 15, 2022
Record last verified: 2022-11