UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021515
Receipt number R000024549
Scientific Title Clinical safety study of salacia aerial extract (herb) formulation
Date of disclosure of the study information 2016/04/02
Last modified on 2016/08/24 18:15:50

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Basic information

Public title

Clinical safety study of salacia aerial extract (herb) formulation

Acronym

Clinical safety study of salacia aerial extract (herb) formulation

Scientific Title

Clinical safety study of salacia aerial extract (herb) formulation

Scientific Title:Acronym

Clinical safety study of salacia aerial extract (herb) formulation

Region

Japan


Condition

Condition

diabetes mellitus

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the safety of salacia aerial extract (herb) in healthy adults

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Medical Questionnaire and physiological examination every 4 weeks

Key secondary outcomes

glucose in blood, blood biochemistry, hematology, urinalysis every 4 weeks


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Administration of salacia aerial extract (180 mg/day) for 12 weeks

Interventions/Control_2


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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) 20 to 70 years at the time of informed concent
(2) Subjects who are considered eligible for the study by the investigator (doctor) at screening
(3) Subjects with FBG level > 126 mg/mL at screening
(4) Subjects who are able to understand the study and comply with all study procedures and willing to provide written informed consent prior to screening.
(5) Subjects who have the eating habits of three meals a day (morning, noon and evening )
(6) Subjects who have not used the other healthy food or dietary supplements during the investigation (Day -28 to 113).

Key exclusion criteria

(1) Subjects who are considered ineligible for the study by the investigator (doctor) due to
current or history of disease, family history, and etc.
(2) If female, subject is pregnant and lactating
(3) Subjects who have been exposed to any investigational foods or drugs within 4 months prior to the first administration
(4) Subjects who have donated 400 mL or more of blood within 12 weeks or 200 mL or more of blood within 4 weeks prior to screening, or have donated any amount of blood prior to the first administration
(5) Subjects who have a history of abuse of drugs and/or alcohol
(6) Subjects who have used insuline, oral hypoglycemic drug, or other drugs
(7) Subjects who have used drugs within 7 days prior to screening
(8) Subjects who are considered ineligible for the study by the investigator (doctor)

Target sample size

16


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Fukase

Organization

CPC Clinical Trial Hospital,Medipolis Medical Research Institute

Division name

Director

Zip code


Address

Toso 4-18-38 Kagoshima

TEL

099-259-2470

Email

fukase@cpc-jp.com


Public contact

Name of contact person

1st name
Middle name
Last name Shigeto Nakashima

Organization

CPC clinical Trial Hospital

Division name

Clinical Trial Project Office

Zip code


Address

Toso 4-18-38 Kagoshima

TEL

099-259-5243

Homepage URL


Email

cpc_contact@cpc-jp.com


Sponsor or person

Institute

CPC Clinical Trial Hospital,Medipolis Medical Research Institute

Institute

Department

Personal name



Funding Source

Organization

Takama Co, LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Organization for Research Initiatives, Yamaguchi University

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 02 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 02 Month 12 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 02 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 03 Month 17 Day

Last modified on

2016 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024549


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name