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Evidence-based evaluation study of Beimu Zhizhu granules in the treatment of reflux cough

Registration number：

ITMCTR2024000387

Date of Last Refreshed on：

2024-09-05

Date of Registration：

2024-09-05

Registration Status：

Prospective registration

Public title：

Evidence-based evaluation study of Beimu Zhizhu granules in the treatment of reflux cough

English Acronym：

Scientific title：

Evidence-based evaluation study of Beimu Zhizhu granules in the treatment of reflux cough

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Hu Xuebing

Study leader：

Wang Bin

Applicant telephone：

19801395495

Study leader's telephone：

13146098570

Applicant Fax：

Study leader's fax：

Applicant E-mail：

19801395495@163.com

Study leader's E-mail：

wjyyhxkwb@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

6 Huajiadi Street, Chaoyang District, Beijing

Study leader's address：

6 Huajiadi Street, Chaoyang District, Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Wangjing Hospital of the Chinese Academy of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

WJEC-KT-2024-038-P002

Approved file of Ethical Committee：

View

Name of the ethic committee：

Wangjing Hospital, China Academy of Chinese Medical Science

Date of approved by ethic committee：

2024/5/29 0:00:00

Contact Name of the ethic committee：

Wang Hao

Contact Address of the ethic committee：

6 Huajiadi Street, Chaoyang District, Beijing

Contact phone of the ethic committee：

+86 84739681

Contact email of the ethic committee：

wjyyec@126.com

Primary sponsor：

Wangjing Hospital China Academy of Chinese Medical Science

Primary sponsor's address：

Wangjing Hospital China Academy of Chinese Medical Science

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Chaoyang

Institution
hospital：

Wangjing Hospital of the Chinese Academy of Traditional Chinese Medicine

Address：

6 Huajiadi Street Chaoyang District Beijing

Source(s) of funding：

Capital health development research project

Target disease：

Reflux cough

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

The research group plans to conduct a prospective, randomized, double-blind, double-simulation, positive drug controlled clinical study, using observation indicators such as cough severity score, reflux cough score, Leicester cough quality of life score, salivary pepsin level, salivary bile acid level, and number of gastric ultrasound contrast-enhanced reflux, to comprehensively and objectively evaluate the efficacy and safety of Beimu Zhizhu granules in treating GERC, providing high-quality evidence-based medical support for the optimization of GERC traditional Chinese medicine guidelines.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Individuals who meet the diagnostic criteria for reflux cough in both traditional Chinese and Western medicine; ② In the past 4 weeks, have not taken with cough, anti-reflux, acid inhibition effect of Chinese medicine/proprietary Chinese medicine/Western medicine; Age ≥18 years old; ④ Voluntarily accept the treatment plan and sign the informed consent.

Exclusion criteria：

① Merge other cough causing diseases; ② Merge severe primary diseases such as cardiovascular, cerebrovascular, liver and kidney, hematopoietic and endocrine systems, and malignancy Tumor patients and high-risk individuals for fractures; ③ Pregnant and lactating women; ④ Individuals who have participated or are currently participating in other clinical trials within the past month; ⑤ Taking warfarin, clopidogrel, aspirin, fenavir/azavir/nefenavir/ Shaquinavir, tacrolimus, voriconazole/posaconazole/ketoconazole/itraconazole, erlotinib, ciloconazole Tazole, diazepam, digoxin, methotrexate, phenytoin, nifedipine, rifampicin, St. John's wort and other drugs Objects; ⑥ Individuals who are known to be allergic to the treatment drugs specified in the protocol.

Study execute time：

From 2024-01-01

To      2026-12-31

Recruiting time：

From 2024-09-10

To      2026-12-31

Interventions：

54

Group：

Observation group

Sample size：

Intervention：

The observation group was given Beimu Zhizhu Granules (mainly composed of 10g of bran fried Fructus Aurantii, 12g of bran fried Atractylodes macrocephala, 15g of Poria cocos, 3g of Chuan Beimu, etc.) orally, one dose per day, diluted with 50-100ml of water, and taken 30 minutes after breakfast and dinner; Oral administration of omeprazole enteric coated capsule mimetic, 1 capsule per time, once daily, 30 minutes before breakfast. The treatment pe

Intervention code：

54

Group：

Control group

Sample size：

Intervention：

The control group was given omeprazole enteric coated capsules orally, 20mg each time, once a day, 30 minutes before breakfast; Beimu Zhizhu Granules Simulated Oral Administration, 1 dose per day, diluted with 50-100ml water, taken 30 minutes after breakfast and dinner. The treatment period is 8 weeks.

Intervention code：

Total sample size ： 108

Countries of recruitment
and research settings：

Country：

中国

Province：

Beijing

City：

Institution/hospital：

Wangjing Hospital of the Chinese Academy of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Reflux Cough Rating Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Leicester cough questionnair

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Salivary pepsin

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Color Doppler gastrointestinal contrast ultrasound

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Salivary bile acid

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Safety indicators [blood routine, urine routine, liver function (ALT, AST), kidney function (CRE, BUN)]

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Cough evaluationg test

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

saliva

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
90
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

This study was randomized, double-blind, double-simulation, positive drug control design, and divided into observation group and control group according to 1:1 ratio. Application of statistical software SAS 9.4 PROC PLAN process statements, a given number of seeds, respectively 108 cases accepted participants processing (test drug and placebo) random number table (i.e., random coding table), import randomized clinical trials system (http://www.eclinica.cn/randomize). The researchers used a random system to obtain random numbers and assign therapeutic drug numbers according to the order of enrollment.

Blinding：

This study adopts a double-blind design and both the subjects and the researchers are unaware of the grouping of the intervention measures. Management and preservation of the blind bottom: The random coding table is established by the clinical trial statistics unit and the blind bottom is divided into two levels. The first level is the group (A and B) corresponding to each random number; the second level is the drug name corresponding to the two treatment groups (A and B). The blind bottom is sealed in duplicate and handed over to the statistics unit and the scientific research department of the clinical research unit for safekeeping. The entire drug coding process is written into a document by the blinder that is the blinding record which is saved as one of the files of the clinical trial. In the random system (IWRS) each coded test drug has a corresponding electronic emergency letter which contains information about the group to which the coded drug belongs so as to break the blind in an emergency. The electronic emergency letter is stored confidentially in the random system and shall not be opened unless necessary. When emergency blind breaking is required the researcher can log in to the random system (PC terminal or mobile phone WeChat applet) to perform the blind breaking operation.

IPD sharing：

No

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

None

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

Data acquisition and management 1. Data traceability, electronic case report form (eCRF) filling and modification The data on the Electronic Case Report Form (eCRF) are derived from the original medical records and are completed by the investigator or investigator designee to ensure the completeness and accuracy of the information. If there are any errors that need to be corrected, the modification shall be carried out in accordance with the eCRF filling instructions, and the eCRF system will automatically record the name of the person who modified the data and the date of the modification. After completion of the eCRF filling, it should be submitted to the EDC system through the network in a timely manner. After the data in the EDC system is confirmed by SDV, DM review, questioning and other processing, researchers need to conduct electronic signature confirmation before data locking. 2. Database design and establishment The database is established by the data department of Beijing Tianchuang Mingda Medical Technology Co., LTD., which shall comply with the requirements of FDA 21 CFR Part 11. The database shall manage data traces such as system login, data entry, modification and deletion. 3. Data verification Data verification includes Edit Check, manual verification, and data verification meetings. The data in the eCRF should be consistent with the source document, and any inconsistency should be explained by the researcher. Any changes or corrections made to the data in the eCRF should have an Audit Trail. The audit trail shall include the date and time of the data change in the EDC, the person who changed it, the reason for the change, the data value before the change, and the data value after the change. This audit trail is system protected and does not allow any human modification or editing. Audit trail records shall be archived and searchable. 4. Challenge After the data is entered and stored in the EDC system, the system check is activated and questions are raised, which need to be reviewed and answered by the investigator or his or her authorized personnel. The data manager will review the researcher's answer and, if the answer is acceptable, close the challenge. CRA/PM/DM/MM In the process of data review, if there is any doubt about the data, it can also open a manual question; After data correction or confirmation, each role should turn off the human challenge that its role has enabled. Subject data lists/reports are programmed to support manual data verification throughout the study. A human challenge can be added to the EDC system when data arises that requires clarification/verification/confirmation by the researcher. The data administrator needs to confirm that all challenges have been resolved before locking the library. 5. The database is locked After data review and confirmation that the established database is correct, the data manager, the main researcher, the statistical analyst, the sponsor and the monitoring manager jointly review the data, and complete the final definition and judgment of the analysis group, and then the data manager locks the database. Generally, a locked database or file cannot be modified. If data problems are found after database locking, PM/DM/PI/Sponsor/SA parties need to discuss together to decide whether to open and modify the database. The procedure for relocking a database is the same as that for locking a database for the first time.

Data Managemen Committee：

Not yet

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

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