ACTRN12605000296639CompletedPhase 2
Randomised placebo controlled study on the safety and efficacy of a herbal tonic for cessation of smoking - five week pilot study
CigArrest Pty ltd0 sites60 target enrollmentStarted: September 5, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 25 Years to 75 Years (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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