Efficacy Study of Herbal Formula CUF2 to Treat Childhood Asthma

This study has been completed.
Sponsor:
Collaborators:
University Grants Committee, Hong Kong
Tuen Mun Hospital
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00636103
First received: March 11, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: CUF2
Other: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Placebo-Controlled Study of the Effect of Traditional Chinese Medicines in the Treatment of Childhood Asthma

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Reduction of steroid dosage [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Asthma symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Lung function test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Biochemical markers [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: July 2002
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CUF2 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 Name: CUF2
Placebo Comparator: Placebo 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


Detailed 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.
  Eligibility

Ages Eligible for Study:   7 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636103

Locations
Hong Kong
Department of Paediatrics, Prince of Wales Hospital
Hong Kong, Hong Kong
Department of Paediatrics, Tuen Mun Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
University Grants Committee, Hong Kong
Tuen Mun Hospital
Investigators
Principal Investigator: Rita YT Sung, MD Chinese University of Hong Kong
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rita Yn Tz Sung / Professor, Department of Paediatrics, The Chinese University of Hong Kong, Prince of Wales Hospital
ClinicalTrials.gov Identifier: NCT00636103     History of Changes
Other Study ID Numbers: ICM/CTS/002, AoE-10/01
Study First Received: March 11, 2008
Last Updated: March 11, 2008
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Traditional Chinese Medicine
Asthma
Paediatric

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014