those who are adapted Kampo formula which include Ephedra Herb
Conditions
Interventions
EFE extract
2 times a day (2 hours after breakfast and dinner) for 6 days =wash out(4 weeks) =Ephedra Herb extract
2 times a day (2 hours after breakfast and dinner) for 6 days
Ephedra Herb extract
2 times a day (2 hours after breakfast and dinner) for 6 days =wash out(4 weeks) =EFE extract
2 times a day (2 hours after breakfast and dinner) for 6 days
Sponsors
Clinical Trial Center, Kitasato University Hospital
National Institute of Health Sciences, Tokiwa Phytochemical Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects have to pass the screening test and fulfill all of following inclusion/exclusion criteria, and be judged eligibility by the investigator. 1. Willingness and ability to communicate and comply with all study requirements. Written informed consent to participate in the study prior to any study procedures. 2. Male subjects aged 20years or older and younger than 45 when written informed consent is obtained. 3. Subjects must be 50kg or more and less than 100kg in weight and 18kg/m2 or more and less than 27kg/m2 in BMI. 4. Subjects must be judged as eligible by the investigator after examining the history tailing, physical examinations and laboratory tests.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse events during the trial period | — |
Countries
Japan
Contacts
Public ContactYoshinobu Sasaki
Kitasato University Hospital Clinical Trial Center
Outcome results
None listed