UMIN-CTR Clinical Trial

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

those who are adapted Kampo formula which include Ephedra Herb

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

adverse events during the trial period

Key secondary outcomes

Study type

Interventional

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

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

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

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

Email

odaguchi@insti.kitasato-u.ac.jp

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

Email

y-sasaki@kitasato-u.ac.jp

Institute

Clinical Trial Center, Kitasato University Hospital

Institute

Department

Personal name

Organization

All Kitasato Project Study (AKPS) Collaborative Research

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

National Institute of Health Sciences,
Tokiwa Phytochemical Co., Ltd.

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北里大学病院（神奈川県）

Date of disclosure of the study information

2016

Year

04

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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