The purpose of this study is to determine the efficacy of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics
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 side effects have been reported. New asthma medications, including leukotriene inhibitors and anti-IgE, have shown limited 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. Additionally, a Phase I study conducted in the United States showed good tolerability to ASHMI. Based on these preliminary studies, we hypothesize that ASHMI will be a safe medication in patients with asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Glucose, Urea and Creatinine Phase I
Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL) and Creatinine(mg/dL) in subjects enrolled in Phase 1
Time frame: 1 week after receiving active drug or placebo
Sodium, Potassium, Chloride and CO2 Phase I
Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and CO2 (meq/L) in subjects enrolled in Phase 1
Time frame: 1 week after receiving active drug or placebo
Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I
Summary of Laboratory data for Serum glutamic pyruvic transaminase and Serum glutamic oxaloacetic transaminase in subjects enrolled in Phase 1
Time frame: 1 week after receiving active drug and placebo
Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I
Summary of Laboratory data for White Blood Cell(cells\*10\^3/uL), Hemoglobin(cells\*10\^3/uL) and Platelet(cells\*10\^3/uL)in subjects enrolled in Phase 1
Time frame: 1 week after receiving active drug and placebo
Hemoglobin Laboratory Results in Phase I
Summary of hemoglobin as Outcome measures included laboratory data for subjects enrolled in Phase 1
Time frame: 1 week
Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study
Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL), Creatinine(mg/dL), Bilirubin Total(mg/dL) and Bilirubin Direct(mg/dL)in subjects in Phase II Limited to Measurements before discontinuation of ASHMI treatment
Time frame: 28 weeks
Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and Bicarbonate(meq/L)in subjects in Phase II Limited to Measurements before discontinuation of ASHMI treatment
Time frame: 28 weeks
Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study
Summary of Laboratory data for Alkaline phosphatase(IU/L),Serum glutamic pyruvic transaminase(IU/L)and Serum glutamic oxaloacetic transaminase(IU/L) in subjects in Phase II study Limited to Measurements before discontinuation of ASHMI treatment
Time frame: 28 weeks
Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study
Summary of Laboratory data for White Blood Cell Count(cells\*10\^3/uL) and Platelet (cells\*10\^3/uL)in Phase II study Limited to Measurements before discontinuation of ASHMI treatment
Time frame: 28 weeks
Laboratory Results for Hemoglobin in Subjects in Phase II Study
Summary of Laboratory data for hemoglobin(g/dL)in subjects in Phase II study. Limited to Measurements before discontinuation of ASHMI treatment
Time frame: 28 weeks