Skip to content

Clinical observation of Lingbao Huxin Pill in patients implanted with pacemakers due to sick sinus syndrome

Clinical observation of Lingbao Huxin Pill in patients implanted with pacemakers due to sick sinus syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067497
Enrollment
Unknown
Registered
2023-01-10
Start date
2022-12-31
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

sick sinus syndrome

Interventions

Study Group 1:Lingbao Huxin Pill for 4 weeks, discontinued for 2 weeks, placebo for 4 weeks
Study Group 2:Placebo for 4 weeks, discontinued for 2 weeks, Lingbao Huxin Pill for 4 weeks

Sponsors

Zhejiang Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.18-80 years old, male or female; 2.Implantation of a pacemaker with a recording function; 3.Have not undergone cardiac surgery within six months; 4.No serious cardiac dysfunction (cardiac function grade III.~IV., NYHA grade); 5.Traditional Chinese medicine distinguishes as qi deficiency and blood stasis; 6.Subject consents and signs informed consent form, and has the ability to comply with the study step, requires a third-party witness to co-sign when neither subject nor legal guardian can read and understand informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with severe primary diseases such as liver, kidney, hematopoietic system, and psychosis; 2.Abnormal liver function: patients with alanine aminotransferase ALT, aspartate aminotransferase AST > 2 times the upper limit of normal, or total bilirubin > upper limit of normal; 3.Abnormal renal function: patients with creatinine exceeding the upper limit of normal, or creatinine clearance CrCl < 50 mL/min (Cockcroft-Gault formula); 4.Female subjects of childbearing age who were pregnant, lactating, or planning to conceive or breastfeed during the study and did not use effective contraception; 5.Participate in other clinical trials within 3 months before participating in this study; 6.Patients who are not suitable for participation in clinical trials in the opinion of the investigators, including those who currently have physical or psychological conditions that prevent them from adhering to the protocol; 7.Those who are allergic to the test drug or its ingredients.

Design outcomes

Primary

MeasureTime frame
Pacemaker programmed parameters;

Secondary

MeasureTime frame
Dynamic electrocardiogram;Left atrial anteroposterior diameter;Left ventricular end-diastolic diameter;Left wall wall end-diastolic septal thickness;Thickness of the posterior wall of the left ventricle;Left ventricular ejection fraction;Grading of cardiac function;

Countries

China

Contacts

Public ContactShuwei Huang

Zhejiang Provincial Hospital of Traditional Chinese Medicine

HSW1104@163.com13957121104

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 14, 2026