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

Recruiting

• Conditions: Adverse Drug Reactions; Severe Adverse Events; Safety Surveillance; Adverse Drug Events; Severe Adverse Reactions
• Interventions: Drug: Qizhi Tongluo Capsules

• Registration Number: NCT04479553
• Lead Sponsor: Zhong Wang

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-21
• Study Start: 2020-08-17
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-15
• Primary Completion: 2023-09
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30000

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Qizhi Tongluo Capsules	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.

Primary Outcome Measures

Name	Time	Method
The incidence of adverse drug reactions (ADR) to the Qizhi Tongluo Capsules	3 years

Secondary Outcome Measures

Name	Time	Method
The incidence of new ADRs 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 immune indicators (IgA, IgE, T-lymphocyte, B lymphocyte, cell surface antigen, serum histamine concentration and complement).
The incidence of serious adverse drug event (SADE) to the Qizhi Tongluo Capsules	3 years
The incidence of adverse drug event (ADE) to the Qizhi Tongluo Capsules	3 years

Trial Locations

Locations (14)

The First Affiliated Hospital of Guangxi University of Chinese Medicine; 🇨🇳 Nanning, Guangxi, China

Shanglin County Hospital 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

Fangchenggang City Hospital of Chinese Medicine; 🇨🇳 Fangchenggang, Guangxi, China

Long'an County Hospital of Chinese Medicine; 🇨🇳 Nanning, Guangxi, China

The Second Affiliated Hospital of Shandong University of Chinese Medicine; 🇨🇳 Jinan, Shandong, China

Affiliated Hospital of Changzhi Institute of traditional Chinese Medicine; 🇨🇳 Changzhi, Shanxi, China

Luohe Hospital of traditional Chinese Medicine; 🇨🇳 Luohe, Henan, China

The First Affiliated Hospital of Xinxiang Medical University; 🇨🇳 Xinxiang, Henan, China

Affiliated Hospital of Yanbian University; 🇨🇳 Yanbian, Jilin, China

Ningming County Hospital of Chinese Medicine; 🇨🇳 Changzuo, Guangxi, 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, China