Efficacy Study of Herbal Formula CUF2 to Treat Childhood Asthma
Efficacy Study of Herbal Formula CUF2 to Treat Childhood Asthma
Asthma is a long-term disease process with genetic, allergic, environmental, infectious,
 emotional and dietary influences. The symptoms control are mainly using an inhaled drug,
 avoiding triggers or taking preventive medicine. Although side effects are unlikely at low
 dose of the asthma treatment, they have become apparent at the higher dose. Due to safety
 concern, parents often turn to complementary and alternative medicine which they believe is
 natural and safe and may help to reduce the conventional medication dosage.

 There are number of reports that treatment with traditional Chinese herbs or formulas
 resulted in significant improvement in lung function and reduction in the airway
 hyper-reactivity reaction. Our study drug CUF2, was based on a classical formulae and had
 been proven to have anti-inflammatory and immunomodulatory activities in laboratory and
 animal studies.

 With the pre-clinical evidence, this study aims to determine the effect of CUF2 on improving
 the clinical symptoms, biochemical markers, and requirement of steroid dosage among children
 with asthma.
Patients are recruited from 2 major governmental hospitals in Hong Kong (Prince of Wales
 Hospital and Tuen Mun Hospital),aged between 7 to 15 years with mild to moderate asthma
 according to the Global Initiative for Asthma guideline, on regular inhaled steroid therapy
 and capable to perform a lung function test.

 However, those patients are excluded if they could not swallow capsules or had received
 parenteral or oral corticosteroids, nedocromil, cromolyn, theophylline or anticonvulsants in
 the past 4 weeks.

 Before study start, written informed consent will be obtained from each patient and one of
 their parents. The eligible patients will be randomly assigned to receive CUF2 or placebo
 capsules for 6 months. For the dosage, children aged above 12 years old, 3 capsules twice
 daily and under 12 years old, 2 capsules twice daily.

 During the 6 months period, below measurements will be taken:

 -  The severity of asthma symptoms was assessed using a modified Disease Severity Score
 (DSS)

 -  Lung Function Test by spirometry (SpiroPro Jaeger Toennies, Hoechberg, Germany)

 -  Conventional Medication consumption, according to GINA/NIH guidelines.

 -  Blood test, EDTA and clotted blood samples were taken at the baseline and end of the
 study for eosinophil counts, IgE level and cytokine assay.
Inclusion Criteria:

 -  Persistent Mild to Moderate Asthma

 -  Aged 7 to 15 years

 -  On Regular inhaled steroid therapy

 -  Able to perform reproducible spirometry

 Exclusion Criteria:

 -  Could not swallow capsules

 -  Received parenteral or oral corticosteroids, nedocromil, cromolyn, theophylline or
 anticonvulsants in past 4 weeks