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Clinical study of Sheng-Mai-Yin in the treatment of arrhythmia caused by antipsychotic drugs

Clinical study of Sheng-Mai-Yin in the treatment of arrhythmia caused by antipsychotic drugs

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036237
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-12-01
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

Schizophrenia

Interventions

Sponsors

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) 18-65 years old, male or female, primary school education or above. 2) According to the diagnostic criteria of ICD-10 "schizophrenia", various arrhythmias were diagnosed by more than one ordinary electrocardiogram, and the diagnostic criteria of traditional Chinese medicine were based on the diagnostic criteria of TCM internal medicine diseases in the industry standard of the State Administration of traditional Chinese Medicine, such as palpitation, deficiency of qi and blood, exuberant fire due to yin deficiency, and heart blood stasis syndrome. 3) The (PANSS) score of the positive and negative symptom scale is >= 60. 4) Antipsychotic treatment, the drug dose is stable for more than 2 weeks. 5) The cultural, social and educational background of the patient or his or her family is sufficient to understand the informed consent and research content and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Participating in other clinical studies. 2) The diagnosis was in accordance with ICD-10 except for schizophrenia. 3) Patients with cardiovascular disease or abnormal ECG before taking antipsychotics, or complicated with severe liver and renal dysfunction, electrolyte disorder, hyperthyroidism and so on. 4) Other serious somatic diseases, brain organic diseases, craniocerebral trauma, etc. 5) There is an obvious risk of committing suicide or endangering yourself or others. 6) Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Electrocardiogram;

Secondary

MeasureTime frame
Myocardial zymogram;Cardiac color ultrasound;PANSS;TCM symptom scale;Blood sugar;Blood lipids;RBANS;SF-36;PSP;Blood pressure;

Countries

China

Contacts

Public ContactZhao Jing

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

maggy-1978@163.com+86 18017311160

Outcome results

None listed

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