Efficacy Study of Herbal Formula CUF2 to Treat Childhood Asthma
NCT ID: NCT00636103
Last Updated: 2008-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2002-07-31
2003-08-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CUF2
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
Placebo
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* Aged 7 to 15 years
* On Regular inhaled steroid therapy
* Able to perform reproducible spirometry
Exclusion Criteria
* Received parenteral or oral corticosteroids, nedocromil, cromolyn, theophylline or anticonvulsants in past 4 weeks
7 Years
15 Years
ALL
No
Sponsors
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University Grants Committee, Hong Kong
OTHER_GOV
Tuen Mun Hospital
OTHER_GOV
Chinese University of Hong Kong
OTHER
Responsible Party
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Department of Paediatrics, The Chinese University of Hong Kong, Prince of Wales Hospital
Principal Investigators
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Rita YT Sung, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Department of Paediatrics, Prince of Wales Hospital
Hong Kong, , Hong Kong
Department of Paediatrics, Tuen Mun Hospital
Hong Kong, , Hong Kong
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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AoE-10/01
Identifier Type: -
Identifier Source: secondary_id
ICM/CTS/002
Identifier Type: -
Identifier Source: org_study_id
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