CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
CUF2 +1 moredrug
Likely dose
CUF2 0.619gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00636103
NCT00636103Phase 2Completed

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

Chinese University of Hong Kong·interventional·Posted Mar 14, 2008·Updated Mar 14, 2008

In Brief

A Phase 2 clinical trial evaluating CUF2 and Placebo for Asthma. Completed, enrolled 90 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesHong Kong

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 14, 2008
Enrollment StartJul 1, 2002
Primary CompletionAug 1, 2003
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.3 years ago

Interventions

CUF2drug

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

Placeboother

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