UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022061 |
|---|---|
| Receipt number | R000025428 |
| Scientific Title | Clinical pharmacological study for safety evaluation of ephedrine alkaloids-free Ephedra Herb extract (EFE) in healthy volunteers |
| Date of disclosure of the study information | 2016/04/26 |
| Last modified on | 2017/04/27 09:51:27 |
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Basic information
Public title
Clinical pharmacological study for safety evaluation of ephedrine alkaloids-free Ephedra Herb extract (EFE) in healthy volunteers
Acronym
Clinical pharmacological study for safety evaluation of ephedrine alkaloids-free Ephedra Herb extract (EFE) in healthy volunteers
Scientific Title
Clinical pharmacological study for safety evaluation of ephedrine alkaloids-free Ephedra Herb extract (EFE) in healthy volunteers
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroshi Odaguchi |
Organization
Oriental Medicine Research Center, Kitasato University
Division name
Center for EVIDENCE-BASED-MEDICINE
Zip code
Address
5-9-1, Shirokane, Minatoku, Tokyo
TEL
03-5791-6346
odaguchi@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Sasaki |
Organization
Kitasato University Hospital
Division name
Clinical Trial Center
Zip code
Address
1-15-1,Kitasato,Minami,Sagamihara, Kanagawa
TEL
042-778-7757
Homepage URL
y-sasaki@kitasato-u.ac.jp
Sponsor or person
Institute
Clinical Trial Center, Kitasato University Hospital
Institute
Department
Personal name
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
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 11 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025428
