Randomised placebo controlled study on the safety and efficacy of a herbal tonic for cessation of smoking - five week pilot study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000296639

Enrollment

Registered

2005-09-05

Start date

2004-09-04

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

A herbal tonic that is taken orally when participants feel like a cigarette over a five week period.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

25 Years to 75 Years

Healthy volunteers

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.

Outcome results