Safety and efficay of a Coleus forskohlii formulation

Safety and efficay of a Coleus forskohlii formulation - Dose escalation of a Coleus forskohlii formulation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008224

Enrollment

Registered

2012-06-21

Start date

2012-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesity

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

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 deseases. - Healthy individuals who have the ability to provide written informed consent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The primary endpoint was safety for phase I. Adverse events.	—

Secondary

Measure	Time frame
Feasibility for phase II study.	—

Countries

Japan

Contacts

Public ContactSeika Kamohara MD, PhD

DHC Corporation Division of Research Adviser

kamohara-seika@umin.ac.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026