Artemisia Annua in the management of Asthma

A randomized double blinded controlled trial on the use of Artemisia Annua in the management of stable Asthmatics

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000639325

Acronym

AAMA

Enrollment

100

Registered

2017-05-02

Start date

2017-07-01

Completion date

2018-07-01

Last updated

2017-05-22

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

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Healthy volunteers

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.

Exclusion criteria

Smoking history over 10 years inability to provide informed consent

Outcome results