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Adjunctive Efficacy and Safety of Qidong Yixin Granules in Patients with Premature Contractions Complicated with Anxiety, Depression or Insomnia: A Multicenter, Prospective, Real-World Study

Adjunctive Efficacy and Safety of Qidong Yixin Granules in Patients with Premature Contractions Complicated with Anxiety, Depression or Insomnia: A Multicenter, Prospective, Real-World Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026000640
Enrollment
Unknown
Registered
2026-03-20
Start date
2026-04-07
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Premature beats complicated with anxiety, depression, or insomnia

Interventions

Qidong Yixin Combined Treatment Group:Qidong Yixin Granules: Oral administration, 5 g per sachet, three times a day (TID), combined with oral metoprolol sustained-release tablets (Betaloc): 47.5 mg pe
Standard Treatment Group:Metoprolol sustained-release tablets (Betaloc): Oral administration, 47.5 mg per dose, once a day (QD) (The dosage of metoprolol may be adjusted according to actual clinical c

Sponsors

Zhejiang Provincial Tongde Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.Aged = 18 years old; 2.Patients diagnosed with cardiac premature beats (including atrial, ventricular, or junctional premature beats), with = 500 premature beats documented by 24-hour ambulatory electrocardiogram (Holter) OR presence of relevant symptoms (e.g., palpitations, chest tightness); 3.Presence of mild to moderate anxiety, depression, or insomnia symptoms (GAD-7 score: 5–14; PHQ-9 score: 5–14; AIS score: 4–15); 4.No use of other antiarrhythmic Chinese patent medicines (e.g., Wenxin Granules, Shensong Yangxin Capsules); 5.Willing to participate in the clinical study and follow-up, and has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Subjects who are unable to understand and complete the relevant scale content due to language, visual, or intellectual impairments, or other reasons; 2.Subjects allergic to Qidong Yixin Granules, metoprolol, or any of their components; 3.Pregnant or lactating women, and women planning to become pregnant in the near future; 4.Subjects planning to use other antiarrhythmic Chinese patent medicines (e.g., Wenxin Granules, Shensong Yangxin Capsules, etc.) besides Qidong Yixin Granules; 5.Patients currently participating in other clinical studies; 6.Subjects deemed ineligible for participation in the clinical trial by the investigators, including but not limited to: those with severe organic diseases, severe heart diseases (acute myocardial infarction, acute heart failure), expected survival time < 6 months, or other diseases that may interfere with the evaluation of the study.

Design outcomes

Primary

MeasureTime frame
The total effective rate of premature beat improvement in both groups of subjects;

Secondary

MeasureTime frame
Patient Health Questionnaire-9 (PHQ-9);Generalized Anxiety Disorder-7 (GAD-7);Athens Insomnia Scale (AIS);

Countries

China

Contacts

Public ContactShen Shenghui

Zhejiang Provincial Tongde Hospital

shensh2002@163.com+86 130 6478 7327

Outcome results

None listed

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