Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000296639
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
5/09/2005
Date last updated
5/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised placebo controlled study on the safety and efficacy of a herbal tonic for cessation of smoking - five week pilot study
Scientific title
Randomised placebo controlled study on the safety and efficacy of a herbal tonic for cessation of smoking - five week pilot study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 384 0
Condition category
Condition code
Public Health 455 455 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A herbal tonic that is taken orally when participants feel like a cigarette over a five week period.
Intervention code [1] 286 0
Treatment: Other
Comparator / control treatment
Placebo tonic
Control group
Placebo

Outcomes
Primary outcome [1] 516 0
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.
Timepoint [1] 516 0
Secondary outcome [1] 1107 0
1) Change in Fagerstrom score
Timepoint [1] 1107 0
At week 5
Secondary outcome [2] 1108 0
2) Difference in daily withdrawal symptoms between active and placebo
Timepoint [2] 1108 0
Over 5 weeks
Secondary outcome [3] 1109 0
3) Difference in daily occasions of cravings between active and placebo
Timepoint [3] 1109 0
Over 5 weeks.

Eligibility
Key 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.
Minimum age
25 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/09/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 504 0
Commercial sector/Industry
Name [1] 504 0
CigArrest Pty Ltd
Country [1] 504 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
CigArrest Pty ltd
Address
Country
Australia
Secondary sponsor category [1] 413 0
None
Name [1] 413 0
NA
Address [1] 413 0
Country [1] 413 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36177 0
Address 36177 0
Country 36177 0
Phone 36177 0
Fax 36177 0
Email 36177 0
Contact person for public queries
Name 9475 0
Dr Phillip Cheras
Address 9475 0
Mater Health Services
Level 2 Community Services Building
South Brisbane QLD 4101
Country 9475 0
Australia
Phone 9475 0
+61 7 38406120
Fax 9475 0
+61 7 38406119
Email 9475 0
[email protected]
Contact person for scientific queries
Name 403 0
Dr Phillip Cheras
Address 403 0
Mater Health Services
Level 2 Community Services Building
South Brisbane QLD 4101
Country 403 0
Australia
Phone 403 0
+61 7 38406120
Fax 403 0
+61 7 38406119
Email 403 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.