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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027036
Receipt No. 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 2017/04/18

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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
Cardiology Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of smoking cessation treatment of yokukansan.
Basic objectives2 Others
Basic objectives -Others Establishment of smoking cessation treatment program.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The rate of achievement of smoking cessation after 12 weeks from the start of test specimen administration.
Key secondary outcomes

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intervention group
An intervention period: One year
A specimen dosage period: 12 weeks
1 cup once, three times a day(7.5g/day),take before breakfast,lunch and dinner.
Interventions/Control_2 placebo group
An intervention period: One year
A specimen dosage period: 12 weeks
1 cup once, 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.The person of the nicotine dependency(more than FTND 5 point)and a person in hope of smoking cessation.
2.The patient of neurosis, the depressed mental state and SDS tests are less than 59 points more than 39 points.
3.Patient not receiving medication on psychiatry, psychosomatic medicine.
4.Intend for an outpatient.
etc
Key exclusion criteria 1.The patient that internal use of the Yokukansan is unfavorable.
2.Patients of serious liver disease (Child class C), patients of renal disease (creatinine clearance less than 14 ml /min)and patients with uncontrolled endocrine disease or complication.
3.Patients who are always taking medicine containing many licorice or glycyrrhizic acid.
4.Without written informed consent.
etc

Target sample size 440

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Hasegawa
Organization National Hospital Organization Kyoto
Medical Center
Division name Division of Translational Research
Zip code
Address 1-1 Mukaihata-cho, Fukakusa, Fushimiku,kyoto citiy
TEL 075-641-9161
Email koj@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Hasegawa
Organization National Hospital Organization Kyoto
Division name Division of Translational Research
Zip code
Address 1-1 Mukaihata-cho, Fukakusa, Fushimiku,kyoto citiy
TEL 075-641-9161
Homepage URL
Email koj@kuhp.kyoto-u.ac.jp

Sponsor
Institute National Hospital Organization Kyoto
Institute
Department

Funding Source
Organization National Hospital Organization operating support funds
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 18 Day
Last modified on
2017 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029561

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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