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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021655
Receipt No. R000024963
Scientific Title Safety of a Coleus forskohlii formulation
Date of disclosure of the study information 2016/03/29
Last modified on 2019/04/01

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Basic information
Public title Safety of a Coleus forskohlii formulation
Acronym Dose escalation of a Coleus forskohlii formulation
Scientific Title Safety of a Coleus forskohlii formulation
Scientific Title:Acronym Dose escalation of a Coleus forskohlii formulation
Region
Japan

Condition
Condition obesity
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Coleus forskohlii (CF) is an Indian botanical which has been used in Ayurvedic medicine. Several small trials have reported the weight-loss effect by the CF extract. The purpose of the study is to evaluate safety of the CF extract in healthy subjects.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome is safety evaluation as phase I. Adverse events are recorded daily basis until 1 week after the intervention. Physician's interview and the physical examinations at the basis and the completion of the intervention.
Key secondary outcomes Subjective questionnaire (the preliminary observation period;1 week, the intervention period, and the post-intervention period;1 week.)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Administered escalating doses start from 110mg/day to 440mg/day. Each dose of a Coleus forskohlii formulation is administered for one week; ie oral intake of 1st wk is 110mg/day, 2nd wk is 220mg/day, 3rd wk is 330mg/day, and 4th wk is 440mg/day. A formulation contains 110mg of CF extract and 100mg of coconut oil per capsule. Each dose includes placebo capsule(s). Therefore, subjects take 4 capsules per day during the intervention.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria - Age: more than or equal to 20 years at the time of providing informed consent

- Healthy individuals who have never experienced psychological and critical diseases.

- Healthy individuals who have the ability to provide written informed consent.
Key exclusion criteria - Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc.) and who is taking any drugs.

- Subjects judged to be inappropriate for the study by the investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Seika
Middle name
Last name Kamohara
Organization DHC Corporation
Division name Division of Research Adviser
Zip code 1060047
Address Minami-azabu 2-7-1, Minato-ku, Tokyo
TEL 0354423945
Email kamohara-seika@umin.ac.jp

Public contact
Name of contact person
1st name Seika
Middle name
Last name Kamohara
Organization DHC Corporation
Division name Division of Research Adviser
Zip code 106-0047
Address Minami-azabu 2-7-1, Minato-ku, Tokyo
TEL 0354423945
Homepage URL
Email kamohara@dhc.co.jp

Sponsor
Institute DHC Corporation
Institute
Department

Funding Source
Organization DHC Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Suidobashi Medical Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization DHC Corporation Life Science Division
Address Azabudai 1-5-7, Minatoku, Tokyo, Japan
Tel 0335852571
Email denpo@dhc.co.jp

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 03 Month 29 Day

Related information
URL releasing protocol https://www.sciencedirect.com/science/article/abs/pii/S2186495016000055?via%3Dihub
Publication of results Unpublished

Result
URL related to results and publications https://www.sciencedirect.com/science/article/abs/pii/S2186495016000055?via%3Dihub
Number of participants that the trial has enrolled 29
Results
https://www.sciencedirect.com/science/article/abs/pii/S2186495016000055?via%3Dihub
Results date posted
2019 Year 04 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://www.sciencedirect.com/science/article/abs/pii/S2186495016000055?via%3Dihub
Participant flow
https://www.sciencedirect.com/science/article/abs/pii/S2186495016000055?via%3Dihub
Adverse events
https://www.sciencedirect.com/science/article/abs/pii/S2186495016000055?via%3Dihub
Outcome measures
https://www.sciencedirect.com/science/article/abs/pii/S2186495016000055?via%3Dihub
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 02 Month 28 Day
Date of IRB
2016 Year 02 Month 27 Day
Anticipated trial start date
2016 Year 03 Month 29 Day
Last follow-up date
2018 Year 03 Month 01 Day
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 28 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024963

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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