UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001412 |
|---|---|
| Receipt number | R000001635 |
| Scientific Title | To investigate the efficacy and safety of Yokukansan for patients with insomnia |
| Date of disclosure of the study information | 2008/10/03 |
| Last modified on | 2009/09/18 16:10:00 |
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Basic information
Public title
To investigate the efficacy and safety of Yokukansan for patients with insomnia
Acronym
To investigate the efficacy and safety of Yokukansan for patients with insomnia
Scientific Title
To investigate the efficacy and safety of Yokukansan for patients with insomnia
Scientific Title:Acronym
To investigate the efficacy and safety of Yokukansan for patients with insomnia
Region
| Japan |
Condition
Condition
Psychophysiological insomnia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of treatment with Yokukansan for patients with psychophysiological insomnia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
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).
Key secondary outcomes
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)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Divide Yokukansan`s daily dosage of 7.5g into three doses and administer before or between meals for 7 consecutive days.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who have been diagnosed with psychophysiological insomnia according to the diagnostic criteria outlined by Internationl Classification of Sleep Disorder II (ICSD II).
2) Patients who report insomnia of greater than 4 weeks of duration.
3) Age specification: Patients who are between ages 20-65 (at the time of signing informed consent).
4) Patients who have signed consent to participate in this research.
5) There is no gender specification.
Key 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.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motohiro Ozone |
Organization
The Jikei university school of medicine
Division name
Department of Psychiatry
Zip code
Address
3-25-8,Nishishinbashi,Minatoku,Tokyo
TEL
03-3433-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motohiro Ozone |
Organization
The Jikei university school of medicine
Division name
Department of Psychiatry
Zip code
Address
3-25-8,Nishishinbashi,Minatoku,Tokyo
TEL
03-3433-1111
Homepage URL
Sponsor or person
Institute
The Jikei university school of medicine
Institute
Department
Personal name
Funding Source
Organization
TSUMURA & Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 10 | Month | 02 | Day |
Last modified on
| 2009 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001635
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| Registered date | File name |
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