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
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
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
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
