A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial for the Effects of Yokukansan on Depressive or Neurotic Smoking Patients during Smoking Cessation Therapy
- Conditions
- nicotine dependence
- Registration Number
- JPRN-UMIN000027036
- Lead Sponsor
- ational Hospital Organization Kyoto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 440
Not provided
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method