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A Clinical Study for the Tiaoweichengqi Decoction on Treating the Metabolic Syndrom Induced by Olanzapine

A Clinical Study for the Tiaoweichengqi Decoction on Treating the Metabolic Syndrom Induced by Olanzapine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019255
Enrollment
Unknown
Registered
2018-11-01
Start date
2018-12-01
Completion date
Unknown
Last updated
2018-11-05

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

Conditions

schizophrenia

Interventions

Group 1:Tiaoweichengqi Decoction and placebo tablet
Group 2:Metformin and palcebo decoction

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Comply with the International Classification of Diseases (ICD-10) diagnostic criteria for schizophrenia; conform to the stomach of Chinese medicine internal medicine Heat and phlegm type syndrome differentiation and treatment; 2. The patient takes olanzapine at a dose that amounts to the minimum and above therapeutic amount of the drug; 3. Meet the clinical diagnostic criteria for the metabolic syndrome of the Chinese Medical Association Diabetes Branch; According to the 2004 Chinese Medicine Recommended Diagnostic Criteria for Learning Diabetes Branch: 3 or all of the following 4 components: (1) Overweight and (or) Obesity: BMI = 25.0 (kg / m2); (2) Hyperglycemia: FPG = 6.lmmol/L (110mg/dL) and/or 2hPG = 7.8mml/L (140mg/dL) and/or have been diagnosed with diabetes and treated; (3) Hypertension: SBP/DBP=140/90mmHg and (or) diagnosed hypertension and treated; (4) dyslipidemia: fasting blood TG = 1.7mmo/L (15Omg/dL) and / or fasting Blood HDL-C <0.9 mmol/L (35 mg / dL) (male), (1.Ommol/L (19mg/dL) (female). 4. male and female aged 18-60 years old; 5. Provide informed consent to participate in the study, signed by the subject or legal guardian.

Exclusion criteria

Exclusion criteria: 1. with serious physical diseases, brain organic diseases, craniocerebral trauma, etc.; 2. Those with acute infections; 3. Patients with acute complications such as diabetic ketoacidosis, or other cardiovascular and cerebrovascular diseases (such as myocardial infarction, Infarction, cerebral hemorrhage); 4. Severe primary liver and kidney diseases, mental patients, pregnant or lactating women, and those who are allergic to this drug; 5. Blood pressure > 160/95 mmHg. 6. Patients who meet the International Classification of Diseases (ICD-10) diagnostic criteria for alcohol, drug dependence, and mental retardation.

Design outcomes

Primary

MeasureTime frame
BMI;blood sugar;TG;leptin;HDL;blood pressure;T CM syndrome scale;

Secondary

MeasureTime frame
Blood concentration of olanzapine;CGI;PANSS;SF-36;PSP;RBANS;

Countries

China

Contacts

Public ContactLiping Zhu

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

zlpjsk@126.com+86 18017311209

Outcome results

None listed

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