Bronchial AsthmaNCT04658992
The Registration on the Use of Feilike Heji in Minors
An observational study of Bronchial Asthma, run by China Academy of Chinese Medical Sciences at 21 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bronchial Asthma
- How many people
- 3,000 participants
- Where
- 21 sitesChina
- Study dates
- 15 Dec 2020to 1 Mar 2022
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All minor patients (age <18 years old) who use Feilike Mixture at the specified monitoring time and in the monitoring center (department) and voluntarily participate in this study and meet ethical requirements.
Who may be able to join
- All minor patients (age <18 years old) who use Feilike Mixture at the specified monitoring time and in the monitoring center (department) .
- Voluntarily participate in this study and meet ethical requirements.
Who cannot join
- Not Applicable.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites, 21 recruiting
- Recruiting
Haicheng Central Hospital
Anshan, Liaoning, 114200
- Recruiting
Beijing Children's Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100045
Jing Liu, Prof., 010-59616885, lljjred@126.com
- Recruiting
Beijing Pinggu Hospital
Beijing, Beijing Municipality, 101200
Xiuying Mao, Bachelor, 13716295500, xiuyingmao@126.com
- Recruiting
Beijing Changping Hospital
Beijing, Beijing Municipality, 102200
Ting Zhou, Bachelor, 13521345341, 13521345341@163.com
- Not yet recruiting
Peking University Binhai Hospital
Beijing, Beijing Municipality, 300450
Ling Yao, Bachelor, 13516118161, yao-ling1960@163.com
- Not yet recruiting
The First People's Hospital of Bijie City
Bijie, Guizhou, 551700
XInqian Zhao, Bachelor, 18076153333, 919299950@qq.com
- Not yet recruiting
Changsha First Hospital
Changsha, Hunan, 410000
XIangyun Wang, Bachelor, 13973123613, wangxiangyun@126.com
- Not yet recruiting
Xiangya San Hospital, Central South University
Changsha, Hunan, 410000
Zuocheng Yang, Doctor, 13787170289, yang_zcr@126.com
- Recruiting
Fengcheng Central Hospital
Fengcheng, Liaoning, 118100
Na Yin, Bachelor, 1394255631, 867142081@qq.com
- Not yet recruiting
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510630
Zhuanggui Chen, Doctor, 13600009221, chenzhuanggui@126.com
- Not yet recruiting
The Second People's Hospital of Huadu District, Guangzhou
Guangzhou, Guangdong, 510850
Hong Zhou, Bachelor, 13926295809, zhouxin86914423@163.com
- Not yet recruiting
Guiyang Maternal and Child Health Hospital
Guiyang, Guizhou, 550003
Fei Wang, Bachelor, 18985016299, 1895016299@qq.com
- Not yet recruiting
Harbin Children's Hospital
Haerbin, Helongjiang, 150010
Yanqiu Zhang, Bachelor, 13654649272, 13654649272@qq.com
- Not yet recruiting
Qilu Hospital
Jinan, Shandong, 250002
- Recruiting
Jiangxi Children's Hospital
Nanchang, Jiangxi, 330000
Lan Li, Master, 13077913093, nclilan@163.com
- Recruiting
Second Affiliated Clinic, Nanjing Medical University
Nanjing, Jiangsu, 210003
Jing Gong, Doctor, 13705189604, njgongjing@outlook.com
- Recruiting
Lotus County Maternal and Child Health Hospital
Pingxiang, Jiangxi, 337100
Zhihao Liu, Bachelor, 15279903368, 1426878742@qq.com
- Recruiting
The First Hospital affiliated with The Chinese Medical University
Shenyang, Liaoning, 110000
Hong Jiang, Master, 13940195519, Jianghong724@163.com
- Not yet recruiting
Shenzhen Pingshan Women's and Children's Health Hospital
Shenzhen, Guangdong, 518112
Hanhua Yang, Doctor, 13537784919, drsam@126.com
- Not yet recruiting
The First Affiliated Hospital of Air Force Military Medical University
Xian, Shanxi, 710032
Xin Sun, Doctor, 13572536262, sunxin001@qq.com
- Recruiting
You County People's Hospital
Zhuzhou, Hunan, 412300
Xirong Fu, Bachelor, 13397536825, 2073623435@qq.com
About this study
Official title: A Study on the Registration of the Use of Feilike Heji in Minors
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.
- Conditions
- Bronchial Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
All adverse events occurred during the study were determined according to CTCAE V5.0 for severity.
Measured: The range of adverse events was from the beginning of the use of Feilike HeJi to 3 days after the cessation of the use of Feilike HeJi.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start15 Dec 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhong Wang, China Academy of Chinese Medical Sciences
- Investigators
- Jing Liu, Prof, Study director, Beijing Children's Hospital affiliated to Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658992
- Sponsor's protocol ID
- Feilike V2.0
- Status last verified
- Aug 2021
- First submitted
- 2 Dec 2020
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Registration of the Use of Feilike Heji in Minors
- ClinicalTrials.gov ID
- NCT04658992
- Acronym / sponsor ID
- Feilike V2.0
- Conditions
- Bronchial Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All minor patients (age <18 years old) who use Feilike Mixture at the specified monitoring time and in the monitoring center (department) and voluntarily participate in this study and meet ethical requirements.
Key inclusion criteria (2 listed)
- All minor patients (age <18 years old) who use Feilike Mixture at the specified monitoring time and in the monitoring center (department) .
- Voluntarily participate in this study and meet ethical requirements.
Key exclusion criteria (1 listed)
- Not Applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AE
Time frame: The range of adverse events was from the beginning of the use of Feilike HeJi to 3 days after the cessation of the use of Feilike HeJi.
All adverse events occurred during the study were determined according to CTCAE V5.0 for severity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Liu, Prof study director
Beijing Children's Hospital affiliated to Capital Medical University
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma, run by China Academy of Chinese Medical Sciences at 21 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Liu, Prof (010-59616885, lljjred@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: The range of adverse events was from the beginning of the use of Feilike HeJi to 3 days after the cessation of the use of Feilike HeJi.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.