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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
