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STA36 is an empirical formula modified from traditional Chinese medicine formula for respiratory disorders containing five herbs for the indication of asthma. Animal studies demonstrated its efficacy via multiple mechanisms, particularly through the reduction of IgE was noticed.
All genotoxicity, acute, sub-acute and chronic toxicity, as well as drug-interaction studies supported that STA36 is a product with high safety profile.
A placebo-controlled double blind clinical trial in 100 subject with mild-to-moderate persistent asthma patients demonstrated, over a period of 4 months, a significant improvement on the percentage of forced expiratory volume in 1 second (%FEV1) and asthmatic symptoms of the subjects in STA36 treatment group was observed and compared to that of the placebo group. Further, no observable adverse effects were found. Given its efficacy and safety, STA36 is considered a credible treatment regimen for persistent, mild-to-moderate asthma. A GCP-compliant, randomized, double-blind, dose ranging, placebo-controlled study is on going to evaluate the efficacy of STA36 in the treatment of mild-to-moderate and persistent asthma in 120 pediatric patients (ages 8~18) as an add-on therapy of leukotriene modifiers. The last patient out is scheduled to be the end of September, 2010. In addition, STA36 has been nominated as one of the Top 10 Inflammatory/Autoimmune Projects to watch by Windhover and Healogi in 2010.
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