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NCT Number: NCT00636103

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Paediatrics, Prince of Wales Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CUF2

Drug

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

Placebo

Other

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

Primary outcomes

  1. Reduction of steroid dosage

    Time frame: 6 months

Secondary outcomes

  1. Asthma symptoms

    Time frame: 6 months

  2. Lung function test

    Time frame: 6 months

  3. Biochemical markers

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Tuen Mun Hospital
  • University Grants Committee, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Mar 14, 2008
Registry last updated
Mar 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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