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Clinical study of Sakurajima Daikon

Clinical study on the efficacy and safety of Sakurajima Daikon on vascular endothelial function: an open randomized usual diet and Aokubi Daikon controlled three-sequence, three-phase crossover IIb study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071210142
Enrollment
21
Registered
2022-03-30
Start date
2022-06-13
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Metabolic syndrome Metabolic syndrome

Interventions

1) Sakurajima Daikon Powder Period: Sakurajima Daikon Powder(Take Yakuhin product, 5g/1pack, 2packs per day) 2packs per day(10g), Take one or two divided doses. 2) Aokubi Daikon Powder Period: Aokubi

Sponsors

Ohishi Mitsuru
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
%FMD at 14 days after the start of feeding

Secondary

MeasureTime frame
1) Trigonelline value at 14 days after the start of feeding. 2) Lipid profile value at 14 days after the start of feeding. - Total cholesterol - Low density lipoprotein cholesterol - High density lipoprotein cholesterol - Triglyceride 3) Measured value at 14 days after the start of feeding. - Urine NOx - Urine 8-OhdG/Urine Creatinine ratio 4) Systolic blood pressure at 14 days after the start of feeding. 5) Diastolic blood pressure at 14 days after the start of feeding.

Contacts

Public ContactYuichi Akasaki

Kagoshima University Hospital

yuichia@m2.kufm.kagoshima-u.ac.jp+81-99-275-5318

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026