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NCT04479553 Clinical Trial

Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.

Adverse Drug Events Clinical Trial

Official title:
Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.

Clinical Trial Details — Status: Recruiting

Administrative data
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

Study information
Verified date November 2022
Source China Academy of Chinese Medical Sciences
Contact Zhong Wang
Phone 86-10-64093207
Email zhonw@vip.sina.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This registry aims to monitor the safety of Qizhi Tongluo Capsules and to identify the potential risk factors for its adverse drug reactions.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Qizhi 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).

Locations
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

Sponsors (2)
Lead Sponsor Collaborator
Zhong Wang Shanxi Zhendong Pharmacy Co., Ltd

Country where clinical trial is conducted

China, 

Outcome
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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