Clinical study of Sheng-Mai-Yin in the treatment of arrhythmia caused by antipsychotic drugs
- Conditions
- Schizophrenia
- Registration Number
- ITMCTR2000003630
- Lead Sponsor
- Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Electrocardiogram;
- Secondary Outcome Measures
Name Time Method Blood sugar;SF-36;Cardiac color ultrasound;PSP;Myocardial zymogram;PANSS;TCM symptom scale;Blood pressure;Blood lipids;RBANS;