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Clinical study of Jiangtang decoction on improving Olanzapine induced weight gain based on regulating Gut microbiota

Clinical study of Jiangtang decoction on improving Olanzapine induced weight gain based on regulating Gut microbiota

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072552
Enrollment
Unknown
Registered
2023-06-16
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Olanzapine induced weight gain

Interventions

Test group: Antipsychotic drugs and life guidance, (1)Single antipsychotic treatment of Olanzapine: Zaipule Tablets (marketed drug), 5mg/tablet, 28 tablets/box, produced by Lilly (China) Suzhou Pharma
Control:Antipsychotic drugs and life guidance, (1)Single antipsychotic treatment of Olanzapine: Zaipule Tablets (marketed drug), 5mg/tablet, 28 tablets/box, produced by Lilly (China) Suzhou Pharmaceut

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? Age 18-65 years old; ? BMI 18.5-23.9 kg/m2; ? Schizophrenic inpatients or outpatient patients diagnosed according to ICD-10. ? In recent three months, systolic blood pressure is 90-139mmHg, diastolic blood pressure is 60-89mmHg, Glycated hemoglobin is 4-6%, total cholesterol is 2.8-5.17mmol/L, triglyceride is 0.56-1.7mmol/L.

Exclusion criteria

Exclusion criteria: Potential participants who meet the inclusion criteria will be excluded if they meet any of the following criteria: ? Any other chronic disease that may affect the stability of Gut microbiota, such as immune deficiency, autoimmune disease, cancer, inflammatory intestinal disease, and diarrhea in the past three months; ? Use drugs that affect Gut microbiota in the past month, including antibiotics, glucocorticoids, cytokines, probiotics and biological agents; ? Those who have undergone gastroscopy, colonoscopy, or gastrointestinal barium meal in the past six months; ? Those who have undergone major gastrointestinal surgery (cholecystectomy and Appendectomy) and intestinal resection within 5 years; ? Individuals with limited mobility due to major physical or mental illnesses; ? In the past six months, there have been significant changes in eating habits (such as changing from meat and vegetarian diet to Vegetarianism); ? There is alcohol or other Substance abuse and dependence; ? Pregnant women; ? Abnormal liver and kidney function; ? Patients known to be allergic to any component of olanzapine and at risk of narrow angle glaucoma.

Design outcomes

Primary

MeasureTime frame
Changes in body mass index;The incidence of weight gain;

Secondary

MeasureTime frame
Changes in blood sugar and blood lipids before and after;Changes in gut microbiota before and after;

Countries

China

Contacts

Public ContactLi Wei-wei

Peking University First Hospital

weiwei_ivy@163.com+86 187 0150 7815

Outcome results

None listed

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