Efficacy Study of Herbal Formula CUF2 to Treat Childhood Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): CUF2; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 0.619g of dried aqueous extract of equal weights of 5 herbs (Astragalus mongholius Bunge, Cordyceps sinensis Sacc., Radix Stemonae, Bulbus Fritillariae Cirrhosae, Radix scutellariae).
The dosage for children above 12 years old was three capsules twice daily and for children under 12 years old two capsules twice daily.
Duration: 6 months; Dark coloured corn starch
The dosage for children above 12 years old was three capsules twice daily and for children under 12 years old two capsules twice daily.
Duration: 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Traditional Chinese Medicine; Asthma; Paediatric