Public Title：A Study on the Registration of The Use of Feilike HeJi in Adults

June 25, 2021 updated by: Zhong Wang, China Academy of Chinese Medical Sciences

Scientific Title：A Study on the Registration of The Use of Feilike HeJi in Adults

Feilike HeJi is produced by Guizhou Jianxing Pharmaceutical Co. LTD. For the treatment of phlegm heat caused by lung cough phlegm yellow, bronchial asthma, bronchitis, see the syndrome of proprietary Chinese medicine (approval number: Z20025136) approved by the state and the drug from radix scutellariae, radix peucedani, radix stemonae, red gentian root of deal, phoenix tree, spreading hedyotis herb, red tube 7 flavour, with qingrejiedu, antitussive expectorant effect. In order to fully understand the safety of Feilike HeJi in clinical practice and fulfill the responsibility of production enterprises for patients, the production enterprises initiated this study to further evaluate the safety and understanding of the function characteristics of Feilike HeJi in a wide range of people, so as to guide the clinical rational drug use.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

3000

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
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
      • Beijing, Beijing, China, 102100
        • Recruiting
        • Peking University Third Hospital Yanqing Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Shenzhen, Guangdong, China, 518033
        • Not yet recruiting
        • The Eighth Affiliated Hospital, Sun Yat-sen University
        • Contact:
      • Shenzhen, Guangdong, China, 518051
        • Not yet recruiting
        • Southern University of Science and Technology Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550001
        • Not yet recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
      • Guiyang, Guizhou, China, 550023
        • Not yet recruiting
        • The Second People's Hospital of Guiyang
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • First Affiliated Hospital, Hunan University of Traditional Chinese Medicine
        • Contact:
      • Changsha, Hunan, China, 410000
        • Recruiting
        • People's Hospital of Ningxiang
        • Contact:
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Xiangtan County People's Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210018
        • Recruiting
        • Nanjing Central Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 211112
        • Not yet recruiting
        • Yifu Hospital Affiliated to Nanjing Medical University
        • Contact:
      • Nankín, Jiangsu, China, 211199
        • Not yet recruiting
        • Nanjing Jiangning Hospital of traditional Chinese Medicine
        • Contact:
    • Jiangxi
      • Guixi, Jiangxi, China, 335400
        • Recruiting
        • Guixi People's Hospital, Jiangxi Province
        • Contact:
      • Nanchang, Jiangxi, China, 330000
        • Not yet recruiting
        • Jiangxi University of Traditional Chinese Medicine Affiliated Hospital
        • Contact:
      • Yichun, Jiangxi, China, 336100
        • Recruiting
        • Wanzai County People's Hospital, Jiangxi Province
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 132000
        • Not yet recruiting
        • Changchun Second Hospital
        • Contact:
    • Liaoning
      • Fuxin, Liaoning, China, 123000
        • Recruiting
        • People's Hospital of Fuxin Mongolian Autonomous County
        • Contact:
    • Shandong
      • Jining, Shandong, China, 272011
        • Recruiting
        • First People's Hospital of Jining City
        • Contact:
          • Jiping Yang, Master
          • Phone Number: 18678769825
      • Linyi, Shandong, China, 276200
        • Not yet recruiting
        • People's Hospital of Mengyin County
        • Contact:
    • Shanxi
      • Ankang, Shanxi, China, 725100
        • Not yet recruiting
        • Hanyin County People's Hospital, Shaanxi Province
        • Contact:
          • Houfang He, Bachelor
          • Phone Number: 18609157810
      • Xian, Shanxi, China, 710000
        • Not yet recruiting
        • First Affiliated Hospital of Xi'an Medical College
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 010100
        • Not yet recruiting
        • Peking University BinHai Hospital
        • Contact:
      • Tianjin, Tianjin, China, 010100
        • Recruiting
        • Tianjin First Central Hospital
        • 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The users of Feilike HeJi in adults.Patients in this study were sourced from outpatient or/and inpatient wards. Outpatient or inpatient patients are selected according to the Settings of the monitoring points of each research center. In other words, if the monitoring points of a research center are outpatient, the outpatient patients can be registered. If the monitoring site includes outpatient and ward, both outpatient and inpatient will need to be registered. The monitoring points of each research center can be one or more departments.

Description

Inclusion Criteria:

  • All adult patients (age ≥18 years old) who use Feilike HeJi at the specified monitoring time and in the monitoring center (department) ;
  • Must voluntarily participate in this study;
  • Must meet ethical requirements.

Exclusion Criteria:

  • NO

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
experimental group
Other: NO.
NO.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AE
Time Frame: From the prescription of Feilike HeJi to 3 days after stop using Feilike HeJi.
All the data to be collected are included in Table A and Table B of the registration And Research Information collection of Adults using Feilike HeJi.Data in Table A are filled in by authorized researchers (such as clinicians) and patients, and data in Table B are filled in by authorized researchers (such as clinicians).
From the prescription of Feilike HeJi to 3 days after stop using Feilike HeJi.

Collaborators and Investigators

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

Sponsor

China Academy of Chinese Medical Sciences

Investigators

  • Study Director: Hongchun Zhang, M.D., China-Japan Friendship Hospital

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)

January 16, 2021

Primary Completion (ACTUAL)

June 1, 2021

Study Completion (ANTICIPATED)

August 1, 2021

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

January 15, 2021

First Posted (ACTUAL)

January 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2021

Last Update Submitted That Met QC Criteria

June 25, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Felike 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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