UMIN-CTR Clinical Trial

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
Email	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
Email	koj@kuhp.kyoto-u.ac.jp

Sponsor
Institute	National Hospital Organization Kyoto
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029561