Asthma Clinical Trial
Official title:
Center for Chinese Herbal Therapy for Asthma. Project #2-Clinical Effect of a Chinese Herbal Therapy in Human Asthma-Phase I
The purpose of this study is to determine the safety of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics and to see what effects ASHMI has on certain parts of the immune system.
Asthma is a major public health problem worldwide, particularly in westernized societies and
has continued to increase in prevalence over the past two decades. Inhaled corticosteroids
have become the first-line treatment for persistent asthma even though significant side
effects have been reported. New asthma medications, including leukotriene inhibitors and
anti-IgE, have shown only marginal benefits. Patients have increasingly turned to
complementary and alternative medicine (CAM) for treatment of their asthma, despite the
uncertainty of its benefits due a lack of well-controlled scientific studies.
We have developed a Chinese herbal formula composed of 3 herbs called ASHMI. It has been
previously shown in murine studies that ASHMI (a formula containing Ling Zhi, Ku Shen and Gan
Cao) has therapeutic effects on the major pathogenic mechanisms of asthma-airway
hyperreactivity, pulmonary inflammation, and airway remodeling, as well as a down-regulating
of TH2 response. A subsequent study in 91 asthmatic patients in Weifang, China found ASHMI to
be a safe and effective alternative to prednisone for treating asthma and exhibited a
beneficial effect on TH1 and TH2 balance. Based on these preliminary studies, we hypothesize
that ASHMI will be a safe medication in atopic patients with asthma and will lead to
identifiable changes in serum immunologic markers.
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