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To evaluate the efficacy and safety of Bailui Granule in the treatment of acute bronchitis (lung syndrome caused by wind and heat)

Registration number：

ITMCTR2200006636

Date of Last Refreshed on：

2022-09-20

Date of Registration：

2022-09-20

Registration Status：

Prospective registration

Public title：

To evaluate the efficacy and safety of Bailui Granule in the treatment of acute bronchitis (lung syndrome caused by wind and heat)

English Acronym：

Scientific title：

To evaluate the efficacy and safety of Bailui Granule in the treatment of acute bronchitis (lung syndrome caused by wind and heat)

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200063906 ; ChiMCTR2200006636

Applicant：

Wang Xifeng

Study leader：

Ban Chengjun

Applicant telephone：

13511056675

Study leader's telephone：

010-84013326

Applicant Fax：

Study leader's fax：

Applicant E-mail：

wangxifeng@qhcro.com

Study leader's E-mail：

banchengjun@sina.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Room 611, Building 1, SDIC Fortune Plaza, 9 Guang 'an Road, Fengtai District, Beijing

Study leader's address：

Haiyancang No.5, Dongcheng District, Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Beijing Qizhuang Technology Co. LTD

Approved by ethic committee：

Approved No. of ethic committee：

2021DZMEC-212-02

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine

Date of approved by ethic committee：

2022/3/2 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine

Primary sponsor's address：

Haiyancang No.5, Dongcheng District, Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine

Address：

Haiyancang No.5, Dongcheng District, Beijing

Source(s) of funding：

Anhui Jiuhua Huayuan Pharmaceutical Co. LTD

Target disease：

acute bronchitis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Post-marketing clinical trial

Objectives of Study：

In this study, positive drug control was used to further clarify the efficacy, safety and clinical advantages of Bailui granule in the treatment of acute bronchitis (lung syndrome caused by wind and heat), so as to provide a basis for the application of this product for the protection of traditional Chinese medicine varieties.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) In line with the diagnosis of acute tracheo-bronchitis in Western medicine; (2) The syndrome differentiation of traditional Chinese medicine is the syndrome of wind and heat invading lung; (3) Onset of acute tracheo-bronchitis (onset time of cough during the course of the disease) ≤3 days; (4) daytime cough symptom score ≥2 points or nighttime cough symptom score ≥2 points; (5) Age 18-65 (including 18 and 65), both genders; (6) Voluntary participation in the clinical trial, informed consent and signed the informed consent form.

Exclusion criteria：

(1) Armpit temperature ≥38.5℃ during the course of the disease; (2) Pneumonia, bronchiectasis, bronchial asthma, cough variant asthma, lung cancer, acute exacerbation of chronic obstructive pulmonary disease and other diseases accompanied with cough, sputum production symptoms or ACEI drug-induced cough; (3) white blood cell count > 11×109/L or neutrophil percentage > 80%; (4) During the course of the disease, before the treatment, the use of antitussive and phlegm-reducing drugs, traditional Chinese medicine decoction, acupuncture and other drugs or non-drug treatment for the disease; Antibiotics were used within 48 hours before treatment; (5) Liver function ALT and AST exceeded the upper limit of the normal reference value 1.5 times or Scr exceeded the upper limit of the normal reference value; (6) Complicated with serious diseases of major organs or systems such as heart, brain, liver, kidney, respiratory system and blood system, such as acute myocardial infarction, acute cerebral infarction, viral hepatitis and hemophilia; (7) Allergic constitution, if there is a history of allergy to two or more drugs or food, or allergic to test drugs (including positive drugs) or their ingredients and excipients; (8) women who are pregnant or planning to become pregnant, breastfeeding women, patients of reproductive age who are unable or unwilling to use adequate contraception during the trial period, or their spouses who are unwilling to use contraception; (9) Suspected or confirmed history of alcohol dependence or drug abuse; (10) having an intellectual or mental handicap; (11) Participated in or is participating in clinical trials of other drugs or medical devices within one month; (12) According to the judgment of the investigator, there are other lesions or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the work environment and unstable living environment, which are likely to cause loss of follow-up.

Study execute time：

From 2022-08-20

To      2023-05-20

Recruiting time：

From 2022-09-20

To      2023-04-18

Interventions：

108

Group：

experimental group

Sample size：

Intervention：

Bairui granule + Reyanning granule simulant，1 bag each time, 3 times a day, wash with boiled water

Intervention code：

54

Group：

Positive medicine group

Sample size：

Intervention：

Bairui granule simulant + Reyanning granule，1 bag each time, 3 times a day, wash with boiled water

Intervention code：

Total sample size ： 162

Countries of recruitment
and research settings：

Country：

CHINA

Province：

Beijing

City：

Institution/hospital：

Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine

Level of the institution：

top three hospitals

Outcomes：

Outcome：

Routine urine and microscopic examination of sediment

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

-

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Bronchitis Severity Score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

blood routine examination

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Sputum symptom score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Curative effect of TCM syndrome

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

liver function

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

renal function

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

health checkup

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Twelve lead electrocardiogram

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Vital signs

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Cough disappearance time

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

AE

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Area under the curve of cough severity-time

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Block randomization was used. According to the given number of random seeds, the random sequences of the treatment group (experimental group, positive drug group) of 162 subjects were generated in a ratio of 2∶1 with the help of SAS 9.4 statistical software, and the assigned drug number (random coding t

Blinding：

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Published academic papers

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

(Electronic Data Capture, EDC）

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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