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Efficacy Study of Herbal Formula CUF2 to Treat Childhood Asthma

NCT00636103 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2008-03-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CUF2

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

OTHER

Placebo

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

Sponsors & Collaborators

  • University Grants Committee, Hong Kong

    collaborator OTHER_GOV

  • Tuen Mun Hospital

    collaborator OTHER_GOV

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Rita YT Sung, MD · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2003-08-31
Completion
2003-08-31

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00636103 on ClinicalTrials.gov