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

November 14, 2022 updated by: Zhong Wang
This registry aims to monitor the safety of Qizhi Tongluo Capsules and to identify the potential risk factors for its adverse drug reactions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangxi
      • Changzuo, Guangxi, China, 532500
        • Recruiting
        • Ningming County Hospital of Chinese Medicine
        • Contact:
          • Jie Liu
      • Fangchenggang, Guangxi, China, 538021
        • Not yet recruiting
        • Fangchenggang City Hospital of Chinese Medicine
        • Contact:
          • Haizhen Pan
      • Nanning, Guangxi, China, 530023
        • Recruiting
        • The First Affiliated Hospital of Guangxi University of Chinese Medicine
        • Contact:
          • Peng Wu
      • Nanning, Guangxi, China, 530500
        • Recruiting
        • Shanglin County Hospital of Chinese Medicine
        • Contact:
          • Guige Tan
      • Nanning, Guangxi, China, 532799
        • Recruiting
        • Long'an County Hospital of Chinese Medicine
        • Contact:
          • Zhenming Lu
    • Henan
      • Luohe, Henan, China, 462000
        • Recruiting
        • Luohe Hospital of traditional Chinese Medicine
        • Contact:
      • Nanyang, Henan, China, 473000
        • Withdrawn
        • The First Affiliated Hospital of Nanyang Medical College
      • Nanyang, Henan, China, 473000
        • Recruiting
        • The Second Affiliated Hospital of Nanyang Medical College
        • Contact:
          • Wanqun Wang
      • Xinxiang, Henan, China, 453199
        • Not yet recruiting
        • The First Affiliated Hospital of Xinxiang Medical University
        • Contact:
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
        • Contact:
      • Zhengzhou, Henan, China, 450003
        • Withdrawn
        • The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
    • Jilin
      • Yanbian, Jilin, China, 133000
        • Withdrawn
        • Affiliated Hospital of Yanbian University
    • Shandong
      • Jinan, Shandong, China, 250001
        • Recruiting
        • The Second Affiliated Hospital of Shandong University of Chinese Medicine
        • Contact:
          • Xingchen Wang
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Recruiting
        • Affiliated Hospital of Changzhi Institute of traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who use Qizhi Tongluo Capsules in the monitoring hospitals.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of adverse drug reactions (ADR) to the Qizhi Tongluo Capsules
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of adverse drug event (ADE) to the Qizhi Tongluo Capsules
Time Frame: 3 years
3 years
The incidence of new ADRs to the Qizhi Tongluo Capsules
Time Frame: 3 years
3 years
The incidence of serious adverse drug event (SADE) to the Qizhi Tongluo Capsules
Time Frame: 3 years
3 years
Changes in biological indicators of patients with serious adverse events
Time Frame: 3 years
Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for liver function (ALT, AST, ALP, TBIL, DBIL)
3 years
Changes in biological indicators of patients with serious adverse events
Time Frame: 3 years
Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for renal function (BUN, SCr, UA)
3 years
Changes in biological indicators of patients with serious adverse events
Time Frame: 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).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhong Wang

Collaborators

Shanxi Zhendong Pharmacy Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2020

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (Actual)

July 21, 2020

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QZTL-V1.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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