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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
experimental group
Other: NO.
NO.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China Academy of Chinese Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Bronchial Asthma

Clinical Trials on NO.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings