UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021655
Receipt number 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 07:12:22

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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 or person

Institute

DHC Corporation

Institute

Department

Personal name



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

Value
https://center6.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