Efficacy Study of Herbal Formula CUF2 to Treat Childhood Asthma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Double-Blind Placebo-Controlled Study of the Effect of Traditional Chinese Medicines in the Treatment of Childhood Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: CUF2
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CUF2<br> | Drug: CUF2<br>* 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<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of steroid dosage |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma symptoms |  | 6 months | 
| Lung function test |  | 6 months | 
| Biochemical markers |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traditional Chinese Medicine, Asthma, Paediatric