Efficacy Study of Herbal Formula CUF2 to Treat Childhood Asthma
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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 |
- Reduction of steroid dosage [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 |
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| Hong Kong | |
| Department of Paediatrics, Prince of Wales Hospital | |
| Hong Kong, Hong Kong | |
| Department of Paediatrics, Tuen Mun Hospital | |
| Hong Kong, Hong Kong | |
| 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 May 19, 2013