UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027036 |
|---|---|
| Receipt number | R000029561 |
| Scientific Title | A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial for the Effects of Yokukansan on Depressive or Neurotic Smoking Patients during Smoking Cessation Therapy |
| Date of disclosure of the study information | 2017/04/18 |
| Last modified on | 2021/04/21 11:51:11 |
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Basic information
Public title
A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial for the Effects of Yokukansan on Depressive or Neurotic Smoking Patients during Smoking Cessation Therapy
Acronym
Yokukansan for Smoking Cessation
Scientific Title
A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial for the Effects of Yokukansan on Depressive or Neurotic Smoking Patients during Smoking Cessation Therapy
Scientific Title:Acronym
Yokukansan for Smoking Cessation
Region
| Japan |
Condition
Condition
nicotine dependence
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of smoking cessation treatment of yokukansan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of achievement of smoking cessation after 12 weeks from the start of test drug administration.
Key secondary outcomes
(1) the degree of change in the SDS/POMS scores from the pre-drug administration screening to the +12W time point (assessment of post-SC depression), (2) adverse events during the trial drug administration period.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention group
An intervention (trial drug administration) period: 12 weeks
1 pack (2.5g), three times a day(7.5g/day),take before breakfast,lunch and dinner.
Interventions/Control_2
Placebo group
An intervention (trial drug administration) period: 12 weeks
1 pack (2.5g), three times a day(7.5g/day),take before breakfast,lunch and dinner.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Current smokers with nicotine dependency (FTND 5 point or more), who wish to quit smoking.
2.Patients with depressed tendency: SDS tests are 59 points or less and 39 points or more.
3.Patients not receiving medication at psychiatric/psychosomatic medical department.
4.Outpatients
Key exclusion criteria
Patients were excluded from this study based on a pre-trial examination and when their attending physician determined that they met at least one of the following conditions:
(1) administration of yokukansan would be inadvisable based on their general condition
(2) complications by diseases such as severe liver disease (Child-Pugh classification of C), kidney disease (creatinine clearance of under 15 ml/min), and uncontrolled endocrine disease,
(3) consistent use of drugs containing large amounts of licorice and glycyrrhizic acid,
(4) history of yokukansan allergy,
(5) currently experiencing symptoms of allergy due to some drug,
(6) currently pregnant, nursing, or intend to become pregnant during the study period,
(7) the attending physician determines that participation in this study would be inappropriate for any other reason (e.g. inability to understand the contents of the study due to dementia).
Target sample size
440
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Hasegawa |
Organization
National Hospital Organization Kyoto
Medical Center
Division name
Division of Translational Research
Zip code
612-8555
Address
1-1 Mukaihatacho Fukakusa Fushimi-ku
TEL
075-641-9161
koj@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Hasegawa |
Organization
National Hospital Organization Kyoto
Division name
Division of Translational Research
Zip code
612-8555
Address
1-1 Mukaihatacho Fukakusa Fushimi-ku
TEL
075-641-9161
Homepage URL
koj@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyoto
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Clinical Research from the National Hospital Organization
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Central Ethical Committee, National Hospital Organization Headquarters
Address
2-5-23 Higashigaoka Meguro-ku Tokyo
Tel
03-5712-5075
kenkyu2004@hosp.go.jp
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
| 2017 | Year | 04 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 23 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 18 | Day |
Last modified on
| 2021 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029561
