diabetes mellitus
Conditions
Interventions
Administration of salacia aerial extract (180 mg/day) for 12 weeks
Sponsors
CPC Clinical Trial Hospital,Medipolis Medical Research Institute
Organization for Research Initiatives, Yamaguchi University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) 20 to 70 years at the time of informed concent (2) Subjects who are considered eligible for the study by the investigator (doctor) at screening (3) Subjects with FBG level > 126 mg/mL at screening (4) Subjects who are able to understand the study and comply with all study procedures and willing to provide written informed consent prior to screening. (5) Subjects who have the eating habits of three meals a day (morning, noon and evening ) (6) Subjects who have not used the other healthy food or dietary supplements during the investigation (Day -28 to 113).
Exclusion criteria
Exclusion criteria: (1) Subjects who are considered ineligible for the study by the investigator (doctor) due to current or history of disease, family history, and etc. (2) If female, subject is pregnant and lactating (3) Subjects who have been exposed to any investigational foods or drugs within 4 months prior to the first administration (4) Subjects who have donated 400 mL or more of blood within 12 weeks or 200 mL or more of blood within 4 weeks prior to screening, or have donated any amount of blood prior to the first administration (5) Subjects who have a history of abuse of drugs and/or alcohol (6) Subjects who have used insuline, oral hypoglycemic drug, or other drugs (7) Subjects who have used drugs within 7 days prior to screening (8) Subjects who are considered ineligible for the study by the investigator (doctor)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medical Questionnaire and physiological examination every 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| glucose in blood, blood biochemistry, hematology, urinalysis every 4 weeks | — |
Countries
Japan
Contacts
Public ContactShigeto Nakashima
CPC clinical Trial Hospital Clinical Trial Project Office
Outcome results
None listed