Safety Confirmation Study on Excessive Intake of Food Containing Peucedanum japonicum Root Extract

UMIN ID: UMIN000055539

Registered date:19/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: No
• Date of first enrollment: 2024/09/28
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Oral intake of the active food (10 tablets in a day; 4 weeks).
Oral intake of the placebo food (10 tablets in a day; 4 weeks).

Outcome(s)

• Primary Outcome: Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: expression number of cases/number of cases analyzed) (Pre-intake, 2 weeks and 4 weeks after intake, and 2 weeks after the end of intake of test food)
• Secondary Outcome: 1) Physical examination. (1) Blood pressure, pulsation. Weight, body fat percentage, BMI. 2) Clinical examination. (1) Hematologic test. Blood biochemical test. Urine analysis. 3) Doctor's interview. (1) 4) Adverse events: number of cases and expression rate of adverse events (expression rate: expression number of cases / number of cases analyzed). (1): Pre-intake, 2 weeks and 4 weeks after intake, and 2 weeks after the end of intake of test food.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1) Participants who receiving medication treatment. 2) Participants who patient or have a history of psychiatric disease, sleep disorder, high blood pressure, diabetes, and hyperlipidemia. 3) Participants who have taken medicines to treat disease in the past 1 month (excluding temporal usage for symptoms e.g., headaches, menstrual pain and colds). 4) Participants who have a history of serious hepatopathy, kidney damage, heart disease, hematological disease and lung disease. 5) Participants who are patient or have a history of serious digestive disease. 6) Participants whose BMI is less than 18.5 kg/m2, and 30kg/m2 or over. 7) Participants with systolic blood pressure less than 90mmHg. 8) Participants who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 9) Participants who experienced unpleasant feeling during blood drawing. 10) Participants who have dysphagia. 11) Participants who have allergies to drug or food. 12) Participants who regularly use Food for Specified Health Use, Food with Functional Claims, etc. 13) Participants who excessively take alcohol (expressed in an amount of alcohol: over 40g/day). 14) Excessive smokers (average of 21 cigarettes / day or over). 15) Shift workers or night workers. 16) Participants who may change their lifestyle during the examination period (e.g., travel for long periods of time). 17) Participants who are pregnant, breastfeeding, or who may become pregnant during the study period. 18) Participants who participated in other clinical studies in the past 3 months. 19) Participants who are judged inappropiate for the study by the principal.

Related Information

• Primary Sponsor: TES Holdings Co., Ltd.
• Source(s) of Monetary Support: Maruzen Pharmaceuticals Co., Ltd.