Clinical pharmacological study for safety evaluation of ephedrine alkaloids-free Ephedra Herb extract (EFE) in healthy volunteers
- Conditions
- those who are adapted Kampo formula which include Ephedra Herb
- Registration Number
- JPRN-UMIN000022061
- Lead Sponsor
- Clinical Trial Center, Kitasato University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 12
Not provided
Subjects will be excluded from the study by the following criteria. The investigator must ensure the criteria basically at the screening visit. 1. Subjects who have a disease of the respiratory system, the digestive system, cardiovascular system, kidney, blood, psychoneurosis or cancer, or who had history of their disease. 2. Subjects who have a surgical history of the digestive system or kidney. 3. Subjects who have an infection of the respiratory system, skin, eye, the digestive system or urinary tract. 4. Subjects who have a hypertension, hyperthyroidism or dysuria, or who had history of their disease. 5. Subjects who have history of epileptic fit or organic insult to the brain and who have possibility of an epileptic seizure. 6. Subjects who have an allergy to food and medicine or who had history of allergy. 7. Subjects who have hay fever (allergic rhinitis). 8. Subjects who smoke. 9. Subjects who showed positive results of Syphilis test, Hepatitis B surface antigen or Hepatitis C. 10. Subjects who had history of drug or alcohol abuse or who showed evidence of such abuse by the laboratory test at the screening. 11. Subjects took any drug or health food containing St Johns wort within 4 weeks before dosing and be judged not eligible for the enrollment of the study by the investigator. 12. Subjects who participated any clinical trials within 12 weeks before dosing of the first period. 13. Subjects who donated 200ml of blood within 4 weeks or 400ml within 12 weeks. 14. Subjects whom the investigator consider ineligible for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method adverse events during the trial period
- Secondary Outcome Measures
Name Time Method