Clinical study based on intestinal flora on the treatment of Xiexin Decoction on Metabolic syndrome caused by Olanzapine

Phase 1

• Conditions: Metabolic syndrome of Schizophrenia patients

• Registration Number: ITMCTR2000003944
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the diagnostic criteria of the International Classification of Diseases (ICD-10) for schizophrenia; It conforms to the syndrome differentiation and treatment of hyperpyremia of stomach in traditional Chinese medicine.
2. Patients should take olanzapine and the dose should reach the minimum therapeutic dose of olanzapine or above;
3. Meet the clinical diagnostic criteria of metabolic syndrome of the Diabetes Branch of the Chinese Medical Association. According to the diagnostic criteria proposed by the Chinese Diabetes Association in 2017, the given metabolic signs can be diagnosed if they have 3 or more of the following 5 components:
(1) Abdominal obesity (i.e. central obesity) : waist circumference >= 90cm for men and >= 85cm for women;
(2) Hyperglycemia: fasting blood glucose >= 6.1mmol/L or 2h blood glucose >= 7.8mmol/L after glucose load and/or diabetes has been confirmed and treated;
(3) Hypertension: blood pressure >= 130/85mmhg and/or has been confirmed as hypertension and treatment;
(4) on an empty stomach TG acuity 1.7 mmon/L;
(5) on an empty stomach HDL - C < 1.04 tendency/L.
4. Regardless of gender, age 18-65 years;
5. An informed consent to participate in the study shall be provided and signed by the subject himself or his legal guardian.

Exclusion Criteria

1. Serious physical diseases, organic brain diseases, craniocerebral trauma, etc.;
2. Complicated with acute infection.
3. Patients with acute complications such as diabetic ketoacidosis or accompanied by other cardiovascular and cerebrovascular diseases (such as myocardial infarction, cerebral infarction and cerebral hemorrhage).
4. Patients with severe primary liver and kidney diseases, psychiatric patients, pregnant or lactating women, and those who are allergic to this drug.
5. Blood pressure > 160/95mmhg.
6. Exclude patients who meet the diagnostic criteria of the International Classification of Diseases (ICD-10) for alcohol and drug dependence and intellectual impairment;

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tess scale;weight;fasting blood sugar;Waist circumference;height;TCM symptom scale;blood lipid;