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AzTrials

AsthmaPhase 1/2NCT00636103

Efficacy Study of Herbal Formula CUF2 to Treat Childhood Asthma

A Phase 1/2 study testing CUF2 in people with Asthma, run by Chinese University of Hong Kong at 2 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 7 to 15 years
Conditions the study is for
Asthma
What is being tested?
CUF2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
2 sitesHong Kong
Study dates
Jul 2002to Aug 2003
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites

  • Department of Paediatrics, Prince of Wales Hospital

    Hong Kong

  • Department of Paediatrics, Tuen Mun Hospital

    Hong Kong

Other trials in Hong Kong

About this study

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

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.

Read the 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.
Conditions
Asthma
Being tested
CUF2, Placebo
Keywords
Traditional Chinese Medicine, Asthma, Paediatric
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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

Study groups in NCT00636103
Study groupRoleWhat they receive
CUF2ExperimentalNot described
Receives: Drug: CUF2
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of steroid dosage

    Measured: 6 months

Secondary outcomes (3)

  1. Asthma symptoms

    Measured: 6 months

  2. Lung function test

    Measured: 6 months

  3. Biochemical markers

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2008 (estimated)
  2. Study startJul 2002
  3. Primary completionAug 2003
  4. Study completionAug 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00636103
Sponsor's protocol ID
ICM/CTS/002
Other IDs
AoE-10/01
Status last verified
Mar 2008
First submitted
11 Mar 2008
Last updated
14 Mar 2008
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 9042632

  • 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.

    PubMed 9568941

  • 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.

    PubMed 10836329

  • 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.

    PubMed 8932956

  • 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.

    PubMed 9116877

  • 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.

    PubMed 10806598

  • 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.

    PubMed 10823504

  • 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.

    PubMed 10812678

  • 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.

    PubMed 10549581

  • 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.

    PubMed 8503668

  • 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.

    PubMed 3605835

  • 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.

    PubMed 19821718

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CUF2 in people with Asthma, run by Chinese University of Hong Kong at 2 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of steroid dosage (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00636103, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2008.

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