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A multicenter randomized controlled study on the efficacy and safety of Qidong Yixin granules combined with metoprolol succinate sustained-release tablets in the treatment of ventricular premature beats (Qi Yin deficiency syndrome)

Registration number：

ITMCTR2024000536

Date of Last Refreshed on：

2024-10-12

Date of Registration：

2024-10-12

Registration Status：

Prospective registration

Public title：

A multicenter randomized controlled study on the efficacy and safety of Qidong Yixin granules combined with metoprolol succinate sustained-release tablets in the treatment of ventricular premature beats (Qi Yin deficiency syndrome)

English Acronym：

Scientific title：

A multicenter randomized controlled study on the efficacy and safety of Qidong Yixin granules combined with metoprolol succinate sustained-release tablets in the treatment of ventricular premature beats (Qi Yin deficiency syndrome)

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Yitao Luo

Study leader：

Xiaohu Chen

Applicant telephone：

17757190606

Study leader's telephone：

13605190639

Applicant Fax：

Study leader's fax：

Applicant E-mail：

493923434@qq.com

Study leader's E-mail：

Chenxhdoctor@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Building 18 South Normal University Xuanwu Science and Technology Park Suojin Village Street Xuanwu District Nanjing City Jiangsu Province

Study leader's address：

No. 155 Hanzhong Road Qinhuai District Nanjing City Jiangsu Province

Applicant postcode：

210042

Study leader's postcode：

210029

Applicant's institution：

Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd

Approved by ethic committee：

Approved No. of ethic committee：

2024NL-106-02

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Nanjing University of Traditional Chinese Medicine Affiliated Hospital (Jiangsu Provincial Hospital of Traditional Chinese Medicine)

Date of approved by ethic committee：

2024/5/8 0:00:00

Contact Name of the ethic committee：

Mao Wang

Contact Address of the ethic committee：

No. 155 Hanzhong Road Qinhuai District Nanjing City Jiangsu Province

Contact phone of the ethic committee：

025-86560515

Contact email of the ethic committee：

llwyhbgs@qq.com

Primary sponsor：

Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd

Primary sponsor's address：

Xiangfu Bridge 866 Moganshan Road Gongshu District Hangzhou City Zhejiang Province

Secondary sponsor：

Country：

China

Province：

JiangSu

City：

Institution
hospital：

Jiangsu Province Hospital of TCM

Address：

No. 155 Hanzhong Road Qinhuai District Nanjing City Jiangsu Province

Source(s) of funding：

Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd

Target disease：

Ventricular premature beats

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Post-marketing clinical trial

Objectives of Study：

Evaluation of the efficacy and safety of Qidong Yixin granules combined with metoprolol succinate sustained-release tablets in the treatment of ventricular premature beats (Qi Yin deficiency syndrome)

Description for medicine or protocol of treatment in detail：

Inclusion criteria

Participants must meet all of the following inclusion criteria: (1) The diagnosis of ventricular premature beats is based on a 12 lead electrocardiogram and the 24-hour dynamic electrocardiogram shows that the number of premature beats is greater than 2000 and less than 20000; (2) The traditional Chinese medicine syndrome differentiation is qi yin deficiency syndrome; (3) Age between 18 and 70 years old (including 18 and 70 years old) gender is not limited; (4) Heart rate ≥ 60bpm; Voluntarily participate in this clinical trial and sign an informed consent form.

Exclusion criteria：

Any of the following cannot be included in the group: (1) Merge malignant or fatal arrhythmias; Combination of grade II-II-II atrioventricular block or structural heart disease; (2) Patients must regularly take medications such as metoprolol succinate sustained-release tablets for the treatment of ventricular premature beats; (3) Liver function ALT and AST exceed the upper limit of normal reference values by 1.5 times or Scr exceeds the upper limit of normal reference values; (4) Combining severe cardiovascular lung liver kidney endocrine or central nervous system diseases (patients with underlying heart disease such as coronary heart disease chronic heart failure etc. can be included in this study); (5) Known to be allergic or ineffective to the investigational drug or its components; (6) Pregnant or lactating women women of childbearing age who cannot take contraceptive measures during the trial period; (7) Participated in clinical trials of other drugs within the past month; The researchers believe that it is not suitable to participate in this clinical trial.

Study execute time：

From 2024-07-01

To      2026-07-01

Recruiting time：

From 2024-11-01

To      2026-05-01

Interventions：

210

Group：

Test group

Sample size：

Intervention：

Qidong Yixin Granules Usage: 1 bag each time 3 times a day. Combined metoprolol succinate sustained-release tablets (Betaloc). 47.5mg each time once a day.

Intervention code：

210

Group：

control group

Sample size：

Intervention：

Metoprolol Succinate Extended Release Tablets (Betaloc). 47.5mg each time once a day.

Intervention code：

Total sample size ： 420

Countries of recruitment
and research settings：

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Zhangjiagang Traditional Chinese Medicine Hospital

Level of the institution：

secondary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Suqian Traditional Chinese Medicine Hospital

Level of the institution：

Class A tertiary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Nanjing Central Hospital

Level of the institution：

Class A tertiary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Huai'an Second People's Hospital

Level of the institution：

Class A tertiary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Changzhou Traditional Chinese Medicine Hospital

Level of the institution：

Class A tertiary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Qidong Second People's Hospital

Level of the institution：

Second Hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Fengxian People's Hospital

Level of the institution：

Class A tertiary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Wujin Traditional Chinese Medicine Hospital

Level of the institution：

Class A tertiary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Nantong Traditional Chinese Medicine Hospital

Level of the institution：

three-level

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Yangzhou Traditional Chinese Medicine Hospital

Level of the institution：

Class A tertiary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Danyang Traditional Chinese Medicine Hospital

Level of the institution：

secondary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Lianyungang Traditional Chinese Medicine Hospital

Level of the institution：

Class A tertiary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Zhenjiang Traditional Chinese Medicine Hospital

Level of the institution：

Class A tertiary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Qidong Traditional Chinese Medicine Hospital

Level of the institution：

secondary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Nanjing Pukou District Traditional Chinese Medicine Hospital

Level of the institution：

Class A tertiary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Huai'an Traditional Chinese Medicine Hospital

Level of the institution：

Class A tertiary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Rugao People's Hospital

Level of the institution：

secondary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Taizhou Fourth People's Hospital

Level of the institution：

three-level

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Suzhou Integrated Traditional Chinese and Western Medicine Hospital

Level of the institution：

three-level

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Nantong University Affiliated Hospital

Level of the institution：

Class A tertiary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Taizhou Traditional Chinese Medicine Hospital

Level of the institution：

Class A tertiary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

The Fourth Affiliated Hospital of Nanjing Medical University

Level of the institution：

Class A tertiary hospital

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Jiangsu Province Hospital of TCM

Level of the institution：

Class A tertiary hospital

Outcomes：

Outcome：

Physical examination

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Blood biochemistry test

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

vital signs

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

routine blood test

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

adverse event

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Traditional Chinese Medicine Symptom Score

Type：

Secondary indicator

Measure time point of outcome：

Day 56

Measure method：

Outcome：

routine urine test

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

总效率

Type：

Primary indicator

Measure time point of outcome：

Day 56

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
70
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Adopting a fully randomized design strategy the sponsor generates random numbers and sorts them using computer software EXCEL creating a randomized list containing grouping information and a randomized envelope containing numbering information. All envelopes shall be kept by the PI of each center in a ratio of one envelope per subject. All envelopes cannot be visually distinguished for obvious differences in appearance and the number information stored inside the envelope cannot be obtained before opening. If and only if the subjects have confirmed their participation in the trial and signed the informed consent form the central PI or research team responsible personnel shall randomly open an envelope and assign a unique inclusion (randomization) number based on the record on the letterhead and compare the results in the randomization list for grouping.

Blinding：

IPD sharing：

No

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

各分中心及申办方保管原始数据

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

Use paper CRF forms

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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