Randomised placebo controlled study on the safety and efficacy of a herbal tonic for cessation of smoking - five week pilot study
- Conditions
- SmokingPublic Health - Health promotion/education
- Registration Number
- ACTRN12605000296639
- Lead Sponsor
- CigArrest Pty ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
1) 3 or more years as a smoker 2) Smoke greater than or equal to 20 cigarettes per day 3) Fagerstrom greater than or equal to 5 4) Exhaled carbon monoxide concentration greater than or equal to 10ppm 5) In good general health.
1) Pregnant or lactating females or women likely to become prgnant during the study2) History of serious or unstable cardiac, renal, hypertensive, pulmonary, endocrine, neurologic or neuropsychiatric disorders 3) History of alcohol or substance abuse4) Regular use of any non-cigarette tobacco products5) Current use of other smoking cessation treatments6) Use of any complementary medicine smoking cessation products in the previous 6 months7) Clinically abnormal liver function at baseline8) Unwilling to comply with study protocol9) Subjects who have participated in another clinical trial in the last 30 days10) Any other condition which in the opinion of the investigators could compromise the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Self reported abstinence from smoking for the final 4 weeks before the 5 week visit of the clinical trial. Subjects' reports of abstinence are verified by exhaled carbon monoxide levels of no greater then 10ppm.[]
- Secondary Outcome Measures
Name Time Method 1) Change in Fagerstrom score[At week 5];2) Difference in daily withdrawal symptoms between active and placebo[Over 5 weeks];3) Difference in daily occasions of cravings between active and placebo[Over 5 weeks.]