Efficacy Study of Herbal Formula CUF2 to Treat Childhood Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636103
• Other study ID #: ICM/CTS/002
• Secondary ID: AoE-10/01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 11, 2008
• Last updated: March 11, 2008
• Start date: July 2002
• Est. completion date: August 2003

Study information

• Verified date: March 2008
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Department of Paediatrics, Prince of Wales Hospital	Hong Kong
Hong Kong	Department of Paediatrics, Tuen Mun Hospital	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Tuen Mun Hospital, University Grants Committee, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (11)

But P, Chang C. Chinese herbal medicine in the treatment of asthma and allergies. Clin Rev Allergy Immunol. 1996 Fall;14(3):253-69. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of steroid dosage		6 months	No
Secondary	Asthma symptoms		6 months	No
Secondary	Lung function test		6 months	No
Secondary	Biochemical markers		6 months	Yes