UMIN-CTR Clinical Trial
| 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 (Ver. 6) |
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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 |
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| Condition | |||
| Condition | obesity | ||
| Classification by specialty |
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| 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 |
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| 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 |
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| Age-upper limit |
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| 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. |
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| 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. |
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| Target sample size | 30 | |||
| Research contact person | |||||||
| Last name of lead principal investigator |
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| 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 | |||||||
| 1st name of contact person |
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| 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 | |
| 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 |
| 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 |
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| 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 |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | https://www.sciencedirect.com/science/article/abs/pii/S2186495016000055?via%3Dihub |
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| Participant flow | https://www.sciencedirect.com/science/article/abs/pii/S2186495016000055?via%3Dihub |
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| Adverse events | https://www.sciencedirect.com/science/article/abs/pii/S2186495016000055?via%3Dihub |
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| Outcome measures | https://www.sciencedirect.com/science/article/abs/pii/S2186495016000055?via%3Dihub |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded | |||||||
| Other | |
| Other related information | |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024963 |
