Skip to content

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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003944
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Metabolic syndrome of Schizophrenia patients

Interventions

control group:metformin
TrCon

Sponsors

Shanghai Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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;

Design outcomes

Primary

MeasureTime frame
Tess scale;weight;fasting blood sugar;Waist circumference;height;TCM symptom scale;blood lipid;

Countries

China

Contacts

Public ContactMengjuan Xing

Shanghai Mental Health Center

xingmj0209@sina.com+86 18017311587

Outcome results

None listed

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