Clinical Study on Dachai-Wendan Decoction in Treating Metabolic Syndrome Caused by Atypical Antipsychotics
- Conditions
- Schizophrenia
- Registration Number
- ITMCTR2100004477
- Lead Sponsor
- Beijing Huilongguan Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
1. Subjects who met the ICD-10 diagnostic criteria for schizophrenia;
2. Patients who met the diagnostic criteria of metabolic syndrome in Chinese guidelines for the prevention and treatment of type 2 diabetes (2017 Edition):
(1) Abdominal obesity (central obesity): waist circumference of male >= 90 cm, female >= 85 cm;
(2) Hyperglycemia: fasting blood glucose >= 6.1 mmol / L or blood glucose >= 7.8 mmol / L 2 h after glucose load and / or diabetes mellitus diagnosed and treated;
(3) Hypertension: blood pressure >= 130 / 85 mmHg and / or confirmed hypertension and treated;
(4) Fasting TG >= 1.70 mmol / L;
(5) Fasting HDL-C < 1.04 mmol / L;
Three or more of the above can be used to diagnose metabolic syndrome.
3. Patients taking atypical antipsychotics had a stable dose for more than 3 months, and their condition was stable, so it was not necessary to adjust the dose of antipsychotics;
4. Patients aged between 18 and 65 years.
1. Patients with impulsive, suicidal and self injurious behaviors;
2. Patients with severe liver and kidney damage, cardiac insufficiency or other acute complications and severe infection;
3. Co infected patients with alcohol, drugs and other substance abuse;
4. Patients with other endocrine diseases such as Cushing's syndrome, or Cardiotropic obesity caused by taking a lot of hormones.
5. Patients with type I diabetes, secondary hypertension and familial dyslipidemia;
6. Patients who are allergic to Chinese herbal ingredients;
7. Patients with abnormal laboratory indexes and clinical significance except metabolic syndrome.
8. Patients during pregnancy and lactation, or those with pregnancy planning within 3 months.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method FBS;BMI;2hPBG;LDL;TG;WC;INS;MBP;HDL;FINS;
- Secondary Outcome Measures
Name Time Method TCM-SI;PANSS;