Clinical safety study of salacia aerial extract (herb) formulatio
- Conditions
- diabetes mellitus
- Registration Number
- JPRN-UMIN000021515
- Lead Sponsor
- CPC Clinical Trial Hospital,Medipolis Medical Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 16
Not provided
(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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Medical Questionnaire and physiological examination every 4 weeks
- Secondary Outcome Measures
Name Time Method glucose in blood, blood biochemistry, hematology, urinalysis every 4 weeks