Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000639325p
Ethics application status
Not yet submitted
Date submitted
23/04/2017
Date registered
2/05/2017
Date last updated
2/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Artemisia Annua in the management of Asthma
Scientific title
A randomized double blinded controlled trial on the use of Artemisia Annua in the management of stable Asthmatics
Secondary ID [1] 291755 0
None
Universal Trial Number (UTN)
U1111-1195-8612
Trial acronym
AAMA
Linked study record
NONE

Health condition
Health condition(s) or problem(s) studied:
Asthma 302979 0
Condition category
Condition code
Respiratory 302445 302445 0 0
Asthma
Alternative and Complementary Medicine 302507 302507 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Artemisia Annua 175mg twice a day oral capsule for 22 weeks
Arm 2 - Placebo - Rice Flour twice a day oral capsule for 22 weeks
Capsule return at the completion of the trial will be requested to monitor adherence
Intervention code [1] 297868 0
Treatment: Drugs
Comparator / control treatment
Control treatment - Rice Flour capsule, 1 capsule twice a day
Control group
Placebo

Outcomes
Primary outcome [1] 301853 0
Peak Expiratory flow rate level as measured with a peak flow meter
Timepoint [1] 301853 0
8 weeks, 22 weeks post trial commencement.
Primary outcome [2] 301854 0
Change in pulmonary function levels as measured with desktop spirometry.
Timepoint [2] 301854 0
8 weeks and 22 weeks post trial commencement.
Secondary outcome [1] 334107 0
Change in Quality of life scores as measured by the Asthma Quality of Life Questionnaire
Timepoint [1] 334107 0
8 weeks and 22 weeks post trial commencement.

Eligibility
Key inclusion criteria
Age over 12 years
Stable Asthma as defined by pulmonary function testing showing a 10% or greater increase in pulmonary function following bronchodilator administration.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Smoking history over 10 years
inability to provide informed consent

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study and as such there is no basis for sample size calculations. The data will be analysed with a simple t-test score.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2017
Actual
Date of last participant enrolment
Anticipated
1/07/2018
Actual
Date of last data collection
Anticipated
1/12/2018
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 8838 0
New Zealand
State/province [1] 8838 0
Waikato

Funding & Sponsors
Funding source category [1] 296255 0
Self funded/Unfunded
Name [1] 296255 0
Dr Stuart Armstrong
Country [1] 296255 0
New Zealand
Primary sponsor type
Individual
Name
Dr Stuart Armstrong
Address
Anglesea Sports Medicine
7-9 Thackeray street
Hamilton
New Zealand
3204
Country
New Zealand
Secondary sponsor category [1] 295171 0
None
Name [1] 295171 0
none
Address [1] 295171 0
none
Country [1] 295171 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 297492 0
Health and Disability Ethics Committee
Ethics committee address [1] 297492 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 297492 0
New Zealand
Date submitted for ethics approval [1] 297492 0
01/06/2017
Approval date [1] 297492 0
Ethics approval number [1] 297492 0

Summary
Brief summary
During trials on Artemisia Annua’s use for malarial treatment anecdotal evidence emerged of its beneficial effect on inflammatory processes including asthma. This has led to further studies specifically looking its anti-inflammatory role. It has been shown to have a direct effect on human bronchial epithelial cells and a study looking at its effect on a mouse allergic asthma model was very promising.
Previous studies have shown the anti-inflammatory potential of Arthrem in vitro and previous animal studies have shown a benefit of the active ingredient Artemisia annua in the treatment of asthma. The mechanism of action of this drug is thought to be downregulation of the inflammatory cascade in the airways of patient’s with inflammatory asthma, but the exact mechanism remains undetermined.
This study is a randomized double blinded randomized control trial looking to compare asthma control in 2 groups. One group will be given the herbal supplement Artemisia annua 175mg twice a day and the other will be given a placebo containing rice flour. It will involve participants over the age of 12 with a less than 10 year smoking history with a diagnosis of stable asthma. It will last 6 months and involve the comparison of asthma control as measured by peak flow, pulmonary function tests and a questionnaire.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74206 0
Dr Stuart Armstrong
Address 74206 0
Anglesea Sports Medicine
7-9 Thackeray Street
Hamilton
New Zealand 3204
Country 74206 0
New Zealand
Phone 74206 0
+64 211492438
Fax 74206 0
Email 74206 0
drsarmstrong@gmail.com
Contact person for public queries
Name 74207 0
Dr Stuart Armstrong
Address 74207 0
Anglesea Sports Medicine
7-9 Thackeray Street
Hamilton
New Zealand 3204
Country 74207 0
New Zealand
Phone 74207 0
+64 211492438
Fax 74207 0
Email 74207 0
drsarmstrong@gmail.com
Contact person for scientific queries
Name 74208 0
Dr Stuart Armstrong
Address 74208 0
Anglesea Sports Medicine
7-9 Thackeray Street
Hamilton
New Zealand 3204
Country 74208 0
New Zealand
Phone 74208 0
+64 211492438
Fax 74208 0
Email 74208 0
drsarmstrong@gmail.com

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.