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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031220185

Registered date:06/07/2022

A single-blind placebo-controlled cross-over study of Yoku-kan-san for sedative effects in healthy Japanese male subjects : objective evaluations of sedative effects by analysis of saccadic eye movement.

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiednone
Date of first enrollment06/07/2022
Target sample size6
Countries of recruitment
Study typeInterventional
Intervention(s)The following three drugs will be administered to six healthy volunteers in a randomized single-blind cross-over design. 1. Yoku-kan-san (Tsumura) 2.5 g 2. Etizolam 1 mg + lactose 2.4 g 3. Lactose 2.5 g For blindness, each drug is filled in five AA-sized DB capsules.

Outcome(s)

Primary OutcomeSaccadic eye movement peak velosity
Secondary Outcome1. Saccadic eye movement reaction time and inaccuracy 2. Plasma orexin concentration 3. Subjective drowsiness evaluated by Visual Analog Scales

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 40age old
GenderMale
Include criteria1) Age: between 20 and 40 years old at the time of obtaining consent. 2) Gender: male 3) BMI (Body Mass Index: kg/m2) is between 18.5 and 25.0 (rounded to the first decimal place). 4) Those who have the capacity to give consent, comply with the rules and regulations during participation in the study, undergo the preliminary examination specified in the study protocol, and report subjective symptoms. 5) Those who are judged to be healthy and eligible to participate in this study by the physician in charge of the research at the preliminary examination specified in the study protocol.
Exclude criteria1) Those with a history of drug abuse/dependence, alcohol abuse/dependence, cardiac, hepatic, renal, pulmonary, occular, or hematologic disease that may affect the evaluation or safety of this study. 2) Those with sleep disturbace with a score of 6 or more evaluated by the Japanese version of Pittsburgh Sleep Quality Index. 3) Those with excessive daytime sleepiness with a score of 11 or more evaluated by the Japanese version of Epworth Sleepiness Scale. 4) Those who had worked or will work a night shift between 2200 and 0700 from a week before the first term until the end of the third term. 5) Those who are taking medications including dietary supplements that may affect the evaluation and safety of this study. 6) Those who have a history of drug allergy. 7) Those who have an allergy to gelatin. 8) Those who have participated in another clinical trial within the last 3 months. 9) Those who are judged by the investigator to be ineligible for the study.

Related Information

Contact

Public contact
Name Jun Miura
Address 6-11-11 Kitakarasuyama, Setagaya-ku, Tokyo, Japan Tokyo Japan 157-8577
Telephone +81-3-3300-5247
E-mail junmiura0815@med.showa-u.ac.jp
Affiliation Showa University Clinical Research Institute for Clinical Pharmacology and Therapeuticsical
Scientific contact
Name Naoki Uchida
Address 6-11-11 Kitakarasuyama, Setagaya-ku, Tokyo, Japan Tokyo Japan 157-8577
Telephone +81-3-3300-5247
E-mail nuchida@med.showa-u.ac.jp
Affiliation Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics