Clinical study of Sakurajima Daiko

Phase 2

• Conditions: Metabolic syndrome

• Registration Number: JPRN-jRCTs071210142
• Lead Sponsor: Ohishi Mitsuru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1) Patients providing written informed and consent to participate in the study
2) Aged >= 18 years (irrespective of sex)
3) Patients with Metabolic syndrome

Exclusion Criteria

1) Patients with active or prior malignancy, heart failure, myocardial infarction.
2) Patients undergoing treatment for the following chronic diseases(excluded hypertension, dyslipidemia and diabetes).
Arrhythmia, Liver disorder*, Renal disorder*, Cerebrovascular disorder, Rheumatoid arthritis, and other chronic diseases.
* The following definitions shall be used for Liver and Renal disorder.
- Liver disorder: AST and ALT are more than 3 times the upper limit of the (facility) reference value.
- Renal disorder: Serum creatine >= 2.4 mg/dL (men), >= 2.0 mg/dL (women).
3) Patients with allergies (to medicines and test food related foods).
4) Patients with pregnancy, on breast-feeding or who wish to become pregnant during trial.
5) Current smoker in the 3 months prior to the date consent was obtained.
6) Patients registered in other clinical trials presently or within 3 months before acquisition consent of this trial.
7) Patients whom physician in charge considered inappropriate for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified