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

NCT ID: NCT04479553

Last Updated: 2022-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-17

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Safety Surveillance Adverse Drug Events Adverse Drug Reactions Severe Adverse Events Severe Adverse Reactions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Qizhi Tongluo Capsules

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanxi Zhendong Pharmacy Co., Ltd

INDUSTRY

Sponsor Role collaborator

Zhong Wang

OTHER

Sponsor Role lead

Responsible Party

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Zhong Wang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ningming County Hospital of Chinese Medicine

Changzuo, Guangxi, China

Site Status RECRUITING

Fangchenggang City Hospital of Chinese Medicine

Fangchenggang, Guangxi, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Guangxi University of Chinese Medicine

Nanning, Guangxi, China

Site Status RECRUITING

Shanglin County Hospital of Chinese Medicine

Nanning, Guangxi, China

Site Status RECRUITING

Long'an County Hospital of Chinese Medicine

Nanning, Guangxi, China

Site Status RECRUITING

Luohe Hospital of traditional Chinese Medicine

Luohe, Henan, China

Site Status RECRUITING

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

Site Status WITHDRAWN

The Second Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

Site Status RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Henan University of traditional Chinese Medicine

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

The Third Affiliated Hospital of Henan University of traditional Chinese Medicine

Zhengzhou, Henan, China

Site Status WITHDRAWN

Affiliated Hospital of Yanbian University

Yanbian, Jilin, China

Site Status WITHDRAWN

The Second Affiliated Hospital of Shandong University of Chinese Medicine

Jinan, Shandong, China

Site Status RECRUITING

Affiliated Hospital of Changzhi Institute of traditional Chinese Medicine

Changzhi, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhong Wang

Role: CONTACT

86-10-64093207

Facility Contacts

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Jie Liu

Role: primary

Haizhen Pan

Role: primary

Peng Wu

Role: primary

Guige Tan

Role: primary

Zhenming Lu

Role: primary

Yingmin Song

Role: primary

13623957063

Wanqun Wang

Role: primary

Ping Zhang

Role: primary

Xinzhi Wang

Role: primary

18638189355

Xingchen Wang

Role: primary

Jinbin Guo

Role: primary

13111251707

Other Identifiers

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QZTL-V1.0

Identifier Type: -

Identifier Source: org_study_id

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