Trials / Completed
CompletedNCT04252131
Therapeutic Effect of Cassia Seed in Obesity of Patients With Schizophrenia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- Calo Psychiatric Center · Academic / Other
- Sex
- All
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
Schizophrenia patients with anti-psychotics have decreased psychiatric symptoms, but have increased the generation of overweight or obesity. There is correlation between obesity, diabetes mellitus, metabolic syndrome, hypertension, hyperlipidemia and cardiovascular disorders. Cassia seed is one of traditional Chinese herbs, that can decline blood lipedema effect. Therefore, the purpose of the present study was to design a randomized, double blind, control group study to assess the therapeutic effect of Cassia seed in schizophrenia patients with obesity.
Detailed description
Total of 92 schizophrenia patients with obesity will be enrolled and divided randomly into: 1) case group, received oral administration of Cassia seed (3.0g), once/day, 12 weeks; 2) control group, received oral administration of Cassia seed placebo (3.0g), once/day (90% of starch and 10% of cassia obtusifolia), 12 weeks. The primary outcome included the changes of body mass index (BMI), waist circumferences (WC); secondary outcome measured included the changes of hemoglobin A1c (HbA1c), total cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, CRP (C-Reactive protein), IL-6, systolic blood pressure, diastolic blood pressure, and meridian energy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cassia seed tablet | traditional Chinese herbs |
Timeline
- Start date
- 2018-05-17
- Primary completion
- 2019-10-31
- Completion
- 2019-10-31
- First posted
- 2020-02-05
- Last updated
- 2020-02-05
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT04252131. Inclusion in this directory is not an endorsement.