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Clinical study for Shen Xian Sheng Mai oral liquid on treating chronic arrhythmia of Yang Deficiency Syndrome

Clinical study on the safe and effective of Shen Xian Sheng Mai oral liquid in treating chronic arrhythmia of Yang Deficiency Syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16007835
Enrollment
Unknown
Registered
2016-01-26
Start date
2016-04-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

slow arrhythmia

Interventions

2:Shen Xian Sheng Mai oral liquid

Sponsors

Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The heart rate is 40–60 beats per minute; 2. Diagnostic criteria in line with slow arrhythmias (Sinus bradycardiaSick sinus syndromeAtrioventricular block); 3. Syndrome of yang-deficiency and slow pulse for TCM; 4. Aged 18 to 75-year-old; 5. SBP 90mmHg to 160mmHg, DBP 60mmHg to 100mmHg; 6. Disable other Anti-arrhythmic drugs more than one weeks. 7. Voluntary subjects and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Serious condition be combined with other Anti-arrhythmia drug treatment (acute myocardial infarction, Acute myocarditis, Drug induced); 2. Patients with syncope caused by a severe bradycardia, bradycardia, bradycardia-tachycardia Syndrome or Atrial Fibrillation; Patients who can not be excluded malignant arrhythmia; 3. Patients have been installed or need to install a pacemaker; 4. Patients with AMI (acute myocardial infarction) or PCI (percutaneous coronary intervention) or CABG (Coronary artery bypass grafting) surgery within 3 months; 5. Unstable blood pressure control (SBP>=160mmHg; DBP>=100mmHg or SDP<90mmHg, DBP <60mmHg); 6. Special Populations (Pregnancy, prepare for pregnancy, lactation women, or incapacity or loss of part of the incapacitated person, such as mental illness, blind, deaf, mute, limb disability, etc.) not suitable for clinical study; 7. Allergic to study drug ingredients; 8. involved in other clinical trials in recent 3 months.

Design outcomes

Primary

MeasureTime frame
Holter;

Secondary

MeasureTime frame
ECG;Adverse effects rate;

Countries

China

Contacts

Public ContactJing Li
cjshcsyc@126.com+86 15822050898

Outcome results

None listed

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