Pilot trial of Codonopsis lanceolata

JRCT ID: jRCTs041230161

Registered date:01/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy volunteers
• Date of first enrollment: 01/03/2024
• Target sample size: 8
• Study type: Interventional

Intervention(s)

Phase 1: Codonopsis lanceolata 2g/day 7days p.o.
Phase 2: Codonopsis lanceolata 4g/day 7days p.o.
Phase 3: Codonopsis lanceolata 8g/day 7days p.o.

Outcome(s)

• Primary Outcome: Safety

Secondary Outcome

1)fatigue
2)dietary intake
3)rate of Skin blood flow
4)body temperature
5)body weight
6)appetite
7)Bowel movements

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Healthy volunteer, age 18+
2) written informed consent
3) Persons with an underlying disease but whose symptoms are well controlled

Exclude criteria

1) Persons with drug or alcohol addiction
2) Pregnant or potentially pregnant
3) Persons deemed by the Principal Investigator or Sub-Principal Investigator to be inappropriate to participate in the study.

Related Information

• Primary Sponsor: Tamaru Satoshi
• Secondary Sponsor: Imai Yasuhito
• Source(s) of Monetary Support: Mie University hospital clinical research scholarship
• Secondary ID(s): Nil known