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

Sponsor
China Academy of Chinese Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04714489
Collaborator
(none)
3,000
Enrollment
25
Locations
6.5
Anticipated Duration (Months)
120
Patients Per Site
18.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: NO.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Scientific Title：A Study on the Registration of The Use of Feilike HeJi in Adults
Actual Study Start Date :
Jan 16, 2021
Actual Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm Intervention/Treatment
experimental group

Other: NO.
NO.

Outcome Measures

Primary Outcome Measures

  1. AE [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 China-Japan Friendship Hospital Beijing Beijing China 100029
2 Peking University Third Hospital Yanqing Hospital Beijing Beijing China 102100
3 The First Affiliated Hospital Of Guangzhou Medical University Guangzhou Guangdong China 510120
4 The Eighth Affiliated Hospital, Sun Yat-sen University Shenzhen Guangdong China 518033
5 Southern University of Science and Technology Hospital Shenzhen Guangdong China 518051
6 Guizhou Provincial People's Hospital Guiyang Guizhou China 550001
7 The Second People's Hospital of Guiyang Guiyang Guizhou China 550023
8 Henan Provincial People's Hospital Zhengzhou Henan China 450000
9 First Affiliated Hospital, Hunan University of Traditional Chinese Medicine Changsha Hunan China 410000
10 People's Hospital of Ningxiang Changsha Hunan China 410000
11 Xiangtan County People's Hospital Changsha Hunan China 410000
12 Nanjing Central Hospital Nanjing Jiangsu China 210018
13 Yifu Hospital Affiliated to Nanjing Medical University Nanjing Jiangsu China 211112
14 Nanjing Jiangning Hospital of traditional Chinese Medicine Nankín Jiangsu China 211199
15 Guixi People's Hospital, Jiangxi Province Guixi Jiangxi China 335400
16 Jiangxi University of Traditional Chinese Medicine Affiliated Hospital Nanchang Jiangxi China 330000
17 Wanzai County People's Hospital, Jiangxi Province Yichun Jiangxi China 336100
18 Changchun Second Hospital Changchun Jilin China 132000
19 People's Hospital of Fuxin Mongolian Autonomous County Fuxin Liaoning China 123000
20 First People's Hospital of Jining City Jining Shandong China 272011
21 People's Hospital of Mengyin County Linyi Shandong China 276200
22 Hanyin County People's Hospital, Shaanxi Province Ankang Shanxi China 725100
23 First Affiliated Hospital of Xi'an Medical College Xian Shanxi China 710000
24 Peking University Binhai Hospital Tianjin Tianjin China 010100
25 Tianjin First Central Hospital Tianjin Tianjin China 010100

Sponsors and Collaborators

  • China Academy of Chinese Medical Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhong Wang, Professor, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT04714489
Other Study ID Numbers:
  • Felike V1.0
First Posted:
Jan 19, 2021
Last Update Posted:
Jun 28, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Asthma

Study Results

No Results Posted as of Jun 28, 2021