NCT00636103

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1 asthma

Timeline
Completed

Started Jul 2002

Typical duration for phase_1 asthma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
Last Updated

March 14, 2008

Status Verified

March 1, 2008

Enrollment Period

1.1 years

First QC Date

March 11, 2008

Last Update Submit

March 11, 2008

Conditions

Asthma

Keywords

Traditional Chinese MedicineAsthmaPaediatric

Outcome Measures

Primary Outcomes (1)

  • Reduction of steroid dosage

    6 months

Secondary Outcomes (3)

  • Asthma symptoms

    6 months

  • Lung function test

    6 months

  • Biochemical markers

    6 months

Study Arms (2)

CUF2

EXPERIMENTAL
Drug: CUF2

Placebo

PLACEBO COMPARATOR
Other: Placebo

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

CUF2
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

Placebo

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Persistent Mild to Moderate Asthma
  • Aged 7 to 15 years
  • On Regular inhaled steroid therapy
  • Able to perform reproducible spirometry

You may not qualify if:

  • Could not swallow capsules
  • Received parenteral or oral corticosteroids, nedocromil, cromolyn, theophylline or anticonvulsants in past 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Paediatrics, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Department of Paediatrics, Tuen Mun Hospital

Hong Kong, Hong Kong

Location

Related Publications (12)

  • Leung R, Wong G, Lau J, Ho A, Chan JK, Choy D, Douglass C, Lai CK. Prevalence of asthma and allergy in Hong Kong schoolchildren: an ISAAC study. Eur Respir J. 1997 Feb;10(2):354-60. doi: 10.1183/09031936.97.10020354.

    PMID: 9042632BACKGROUND

  • Lau YL, Karlberg J. Prevalence and risk factors of childhood asthma, rhinitis and eczema in Hong Kong. J Paediatr Child Health. 1998 Feb;34(1):47-52. doi: 10.1046/j.1440-1754.1998.00217.x.

    PMID: 9568941BACKGROUND

  • Rao R, Gregson RK, Jones AC, Miles EA, Campbell MJ, Warner JO. Systemic effects of inhaled corticosteroids on growth and bone turnover in childhood asthma: a comparison of fluticasone with beclomethasone. Eur Respir J. 1999 Jan;13(1):87-94. doi: 10.1183/09031936.99.13108799.

    PMID: 10836329BACKGROUND

  • But P, Chang C. Chinese herbal medicine in the treatment of asthma and allergies. Clin Rev Allergy Immunol. 1996 Fall;14(3):253-69. doi: 10.1007/BF02802218. No abstract available.

    PMID: 8932956BACKGROUND

  • Hsieh KH. Evaluation of efficacy of traditional Chinese medicines in the treatment of childhood bronchial asthma: clinical trial, immunological tests and animal study. Taiwan Asthma Study Group. Pediatr Allergy Immunol. 1996 Aug;7(3):130-40. doi: 10.1111/j.1399-3038.1996.tb00120.x.

    PMID: 9116877BACKGROUND

  • Critchley JA, Zhang Y, Suthisisang CC, Chan TY, Tomlinson B. Alternative therapies and medical science: designing clinical trials of alternative/complementary medicines--is evidence-based traditional Chinese medicine attainable? J Clin Pharmacol. 2000 May;40(5):462-7. doi: 10.1177/00912700022009224.

    PMID: 10806598BACKGROUND

  • Lin LZ, He XG, Lindenmaier M, Nolan G, Yang J, Cleary M, Qiu SX, Cordell GA. Liquid chromatography-electrospray ionization mass spectrometry study of the flavonoids of the roots of Astragalus mongholicus and A. membranaceus. J Chromatogr A. 2000 Apr 21;876(1-2):87-95. doi: 10.1016/s0021-9673(00)00149-7.

    PMID: 10823504BACKGROUND

  • Patocka J. Anti-inflammatory triterpenoids from mysterious mushroom Ganoderma lucidum and their potential possibility in modern medicine. Acta Medica (Hradec Kralove). 1999;42(4):123-5.

    PMID: 10812678BACKGROUND

  • Cheong J, Jung W, Park W. Characterization of an alkali-extracted peptidoglycan from Korean Ganoderma lucidum. Arch Pharm Res. 1999 Oct;22(5):515-9. doi: 10.1007/BF02979162.

    PMID: 10549581BACKGROUND

  • Kong XT, Fang HT, Jiang GQ, Zhai SZ, O'Connell DL, Brewster DR. Treatment of acute bronchiolitis with Chinese herbs. Arch Dis Child. 1993 Apr;68(4):468-71. doi: 10.1136/adc.68.4.468.

    PMID: 8503668BACKGROUND

  • Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease (COPD) and asthma. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, November 1986. Am Rev Respir Dis. 1987 Jul;136(1):225-44. doi: 10.1164/ajrccm/136.1.225.

    PMID: 3605835BACKGROUND

  • Wong EL, Sung RY, Leung TF, Wong YO, Li AM, Cheung KL, Wong CK, Fok TF, Leung PC. Randomized, double-blind, placebo-controlled trial of herbal therapy for children with asthma. J Altern Complement Med. 2009 Oct;15(10):1091-7. doi: 10.1089/acm.2008.0626.

    PMID: 19821718DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Rita YT Sung, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 14, 2008

Study Start

July 1, 2002

Primary Completion

August 1, 2003

Study Completion

August 1, 2003

Last Updated

March 14, 2008

Record last verified: 2008-03

Locations

HK(2)