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Clinical Study on Dachai-Wendan Decoction in Treating Metabolic Syndrome Caused by Atypical Antipsychotics

Clinical Study on Dachai-Wendan Decoction in Treating Metabolic Syndrome Caused by Atypical Antipsychotics

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004477
Enrollment
Unknown
Registered
2020-11-14
Start date
2020-12-31
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

Schizophrenia

Interventions

Sponsors

Beijing Huilongguan Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
FBS;BMI;2hPBG;LDL;TG;WC;INS;MBP;HDL;FINS;

Secondary

MeasureTime frame
TCM-SI;PANSS;

Countries

China

Contacts

Public ContactYan Shaoxiao

Beijing Huilongguan Hospital

393831968@qq.com+86 13811217058

Outcome results

None listed

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