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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)

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)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000536
Enrollment
Unknown
Registered
2024-10-12
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular premature beats

Interventions

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

Sponsors

Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
overall efficiency;

Secondary

MeasureTime frame
Traditional Chinese Medicine Symptom Score;

Countries

China

Contacts

Public ContactXiaohu Chen

Jiangsu Province Hospital of TCM

Chenxhdoctor@126.com13605190639

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026