Efficacy and safety of Vernonia cinerea for smoking cessatio
- Conditions
- tobacco dependenceVernonia cinereanortriptylinesmoking cessationSmoking cessationSafety of long term used of Vernonia cinereasafety
- Registration Number
- TCTR20190506002
- Lead Sponsor
- amphong Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 84
Adults with smoking dependence were screened for participation in the study. Inclusion criteria included moderate to severe nicotine dependence (Heaviness of smoking index, HSI) ≥3 at least 1 month before randomization
Patients with a history of either Vernonia cinerea or nortriptyline allergy, comorbidities (heart disease, cancer, urinary retention, benign prostatic hyperplasia, glaucoma, abnormal vision, dry mouth, constipation, history of gut obstruction, abnormal function of either liver or kidney, abnormal serum potassium level, neurological disorder, depression, used other types of tobacco, used other substances), pregnancy, on breastfeeding period, used MAOIs drug at least 14 days before randomization, used drugs that may cause drug interactions with nortriptyline and used other drugs for smoking cessation were excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method continuous abstinence rate 12 weeks self-report, direct observe treatment, exhaled carbon monoxide level
- Secondary Outcome Measures
Name Time Method continuous abstinence rate 2, 4, 8, 24 weeks self-report, direct observe treatment, exhaled carbon monoxide level,amount of cigarette per day 2, 4, 8, 12, 24 weeks self-report, direct observe treatment,exhaled carbon monoxide level 2, 4, 8, 12, 24 weeks ีSmokerlyzer device (-ppm),adverse events 2, 4, 8, 12, 24 weeks self-report, direct observe treatment,withdrawal symptoms. 2, 4, 8, 12, 24 weeks self-report, direct observe treatment