Smoking cessation Safety of long term used of Vernonia cinerea Vernonia cinerea nortriptyline tobacco dependence smoking cessation safety
Conditions
Interventions
Participants in intervention group
received a 2 gram of Vernonia cinerea tea bag premeal three times daily by pouring 150 mL boiling water over tea bag,
stirring well,
covering cup for 15 minutes before drinking for 12 weeks. ,nortriptyline started at 25 mg before bed once daily for days 1 through 3,
followed by 50 mg once daily for days 3 through 7,
and then 75 mg once daily for days 8 through 28 for reduced potential adverse events.
Experimental Drug,Active Comparator Drug
Vernonia cinerea ,nortriptyline
Sponsors
Namphong Hospital
Khon Kaen Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| continuous abstinence rate 12 weeks self-report, direct observe treatment, exhaled carbon monoxide level | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactKrissanaporn Tuenthosarn
Khon Kaen Hospital Institute Review Board in Human Research.
Outcome results
None listed