UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical pharmacological study for safety evaluation of ephedrine alkaloids-free Ephedra Herb extract (EFE) in healthy volunteers
Title of the study (Brief title)	Clinical pharmacological study for safety evaluation of ephedrine alkaloids-free Ephedra Herb extract (EFE) in healthy volunteers
Region	Japan

Condition
Condition	those who are adapted Kampo formula which include Ephedra Herb
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In a double-blind, crossover study, a safety of repeated oral dose of EFE for 6 days is investigated as compared with that of Ephedra Herb extract.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	adverse events during the trial period
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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
Interventions/Control_2	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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	45 years-old >=
Gender	Male
Key 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.
Key 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.
Target sample size	12

Research contact person
Name of lead principal investigator	Hiroshi Odaguchi
Organization	Oriental Medicine Research Center, Kitasato University
Division name	Center for EVIDENCE-BASED-MEDICINE
Address	5-9-1, Shirokane, Minatoku, Tokyo
TEL	03-5791-6346
Email	odaguchi@insti.kitasato-u.ac.jp

Public contact
Name of contact person	Yoshinobu Sasaki
Organization	Kitasato University Hospital
Division name	Clinical Trial Center
Address	1-15-1,Kitasato,Minami,Sagamihara, Kanagawa
TEL	042-778-7757
Homepage URL
Email	y-sasaki@kitasato-u.ac.jp

Sponsor
Institute	Clinical Trial Center, Kitasato University Hospital
Institute
Department

Funding Source
Organization	All Kitasato Project Study (AKPS) Collaborative Research
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National Institute of Health Sciences, Tokiwa Phytochemical Co., Ltd.
Name of secondary funｄer(s)	None

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	北里大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 11 Day
Anticipated trial start date	2016 Year 04 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 25 Day
Last modified on	2017 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025428