To investigate the efficacy and safety of Yokukansan for patients with insomnia

UMIN ID: UMIN000001412

Registered date:03/10/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Psychophysiological insomnia
• Date of first enrollment: 2008/10/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Divide Yokukansan`s daily dosage of 7.5g into three doses and administer before or between meals for 7 consecutive days.

Outcome(s)

• Primary Outcome: Perform PSG before and after administering Yokukansan for seven consecutive days. PSG data will then be investigated with R&K and CAP(Cyclic alternating pattern).
• Secondary Outcome: 1. Acti-graph (device to measure activity level) : Device is worn throughout the entire duration of the test, from 3 days prior to performing PSG until the end of test. 2. Sleep diary: Recorded 3 days prior to performing PSG until the end of test. 3. PSQ (Pittsburgh Sleep Quality Index): Recorded before PSG is performed. 4. PVT (psychomotor vigilance task): Performed after PSG testing (1. immediately upon waking, 2. at 9am, 3. at 11am) 5. VAS (visual analog scale): Recorded after PSG is performed (1. immediately upon waking, 2. at 9am, 3. at 11am) 6. SSS (Standford Sleepiness Scale): Raecorded after PSG is performed (1. immediately upon waking, 2. 9:00AM, 3. 11:00AM) 7. SAM (Space Aeromedicine Fatigue Checklist): Recorded after PSG is performed (1. immediately upon waking, 2. 9:00AM, 3. 11:00AM) 8. SMH (St. Mary`s Hospital Sleep Questionnaire): Recorded after PSG is performed (1. 8:00AM)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients with insomnia that accompany schizophrenia and manic-depressive psychosis. 2) Patients with pharmacologically-induced insomnia, including anti-Parkinson`s, anti-hypertensive and steroid-type drugs. 3) Patients with insomnia due to serious psychosomatic disorders. 4) Patients who have sleep-related respiratory disorders, Periodic Limb Movement Disorder and Restless Leg Syndrome. 5) Patients who have taken Kampo medicine within the last 4 weeks. 6) Patients who have taken psychotropic drugs, anti-histamine drugs, or melatonin, etc. within the last 4 weeks. 7) Patients who have participated in research with other interventions. 8) Patients who are otherwise classified as unfit by the attending physicians for the research.

Related Information

• Primary Sponsor: The Jikei university school of medicine
• Source(s) of Monetary Support: TSUMURA & Co.