Unique ID issued by UMIN | UMIN000008224 |
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Receipt number | R000009560 |
Scientific Title | Safety and efficay of a Coleus forskohlii formulation |
Date of disclosure of the study information | 2012/06/21 |
Last modified on | 2012/12/21 09:18:55 |
Safety and efficay of a Coleus forskohlii formulation
Dose escalation of a Coleus forskohlii formulation
Safety and efficay of a Coleus forskohlii formulation
Dose escalation of a Coleus forskohlii formulation
Japan |
obesity
Not applicable | Adult |
Others
NO
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 and efficay of the CF extract in healthy subjects.
Safety,Efficacy
The primary endpoint was safety for phase I. Adverse events.
Feasibility for phase II study.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Food |
Administered escalating doses start from 250mg/day to 1,000mg/day. Each dose of a Coleus forskohlii formulation is administered for one week; ie oral intake of 1st wk is 250mg/day, 2nd wk is 500mg/day, 3rd wk is 750mg/day, and 4th wk is 1,000mg/day.
20 | years-old | <= |
60 | years-old | > |
Male and Female
- Age: more than or equal to 20 years at the time of providing informed consent
- Healthy individuals who have never experienced psychological and critical deseases.
- Healthy individuals who have the ability to provide written informed consent.
- 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.
30
1st name | |
Middle name | |
Last name | Seika Kamohara MD, PhD |
DHC Corporation
Division of Research Adviser
Minami-azabu 2-7-1, Minato-ku, Tokyo
1st name | |
Middle name | |
Last name | Seika Kamohara MD, PhD |
DHC Corporation
Division of Research Adviser
kamohara-seika@umin.ac.jp
DHC Corporation
DHC Corporation
Profit organization
Suidobashi Medical Clinic
NO
2012 | Year | 06 | Month | 21 | Day |
Unpublished
Completed
2012 | Year | 05 | Month | 02 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 06 | Month | 21 | Day |
2012 | Year | 12 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009560
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