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Study on the Protective Mechanism of Guanxin Ning Tablets against Cardiovascular Adverse Reactions in Schizophrenia Patients Long-Term Treated with Second-Generation Antipsychotic Drugs

Study on the Protective Mechanism of Guanxin Ning Tablets against Cardiovascular Adverse Reactions in Schizophrenia Patients Long-Term Treated with Second-Generation Antipsychotic Drugs

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100291
Enrollment
Unknown
Registered
2025-04-07
Start date
2023-01-16
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

Schizophrenia

Interventions

Experimental group:Guanxin Ning Tablets
control group:placebo

Sponsors

Hangzhou Seventh People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the diagnostic criteria for schizophrenia as outlined in the ICD-10 Diagnostic and Statistical Manual; 2. Regularly taking second-generation antipsychotic drugs for at least one year; 3. Age of 18 years or older; 4. Long-term inpatient; 5. Abnormalities found in two consecutive electrocardiogram (ECG) tests.

Exclusion criteria

Exclusion criteria: 1. Patients who are on a drug treatment plan involving the use of antidepressants or first-generation antipsychotic drugs; 2. Patients using traditional Chinese patent medicines for promoting blood circulation and removing blood stasis; 3. Patients who are unable to take Guanxin Ning tablets as prescribed or unable to complete relevant evaluations; 4. Patients with severe cardiovascular diseases (congenital heart disease, previous heart surgery); 5. Patients with autoimmune or endocrine system diseases excluded; 6. Patients with uncontrolled grade III hypertension (systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg), severe heart and lung insufficiency, severe arrhythmia, or severe primary diseases of the liver, kidneys, and hematopoietic system, or severe diseases affecting survival (such as tumors, etc.); 7. Patients with other clinical conditions that may increase the risk of bleeding, such as a history of bleeding in important organs within the past six months (such as cerebral hemorrhage, upper gastrointestinal bleeding, etc.), decreased platelet count, abnormal coagulation function, or currently taking warfarin for anticoagulation treatment; 8. Patients with abnormal liver and kidney function indicators (ALT, AST, Scr exceeding 1.5 times the upper limit of the normal reference range); 9. Patients with an allergic constitution, or those allergic to multiple drugs and foods, or those known to be allergic to the test drug (including its components); 10. Patients with pregnancy plans or pregnant and lactating women; 11. Patients who have participated in other clinical trials within the past month; 12. Other situations deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
QT interval;Ejection fraction,EF;

Secondary

MeasureTime frame
Heart rate;The level of ST-segment depression;

Countries

China

Contacts

Public ContactJuan Yan

Hangzhou Seventh People's Hospital

294162939@qq.com+86 135 8821 6288

Outcome results

None listed

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