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

Not Applicable

• Conditions: Psychophysiological insomnia

• Registration Number: JPRN-UMIN000001412
• Lead Sponsor: The Jikei university school of medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-03
• Study Completion: 2009-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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)