Effectiveness of Chinese Herbal Therapy for Asthma - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00712296

Purpose

The purpose of this study is to determine the efficacy of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics

Condition	Intervention	Phase
Asthma	Drug: ASHMI Drug: Placebo	Phase II

MedlinePlus related topics: Asthma Herbal Medicine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Center for Chinese Herbal Therapy for Asthma. Project #2-Clinical Effect of a Chinese Herbal Therapy in Human Asthma-Phase II

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Number of patients whose asthma medication regimen (Inhaled corticosteroids) can be stepped down at least two levels [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pulmonary function tests [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Asthma symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Asthma-related quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Airway hyperreactivity [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
Acute asthma-related resource utilization [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Immunologic markers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	August 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ASHMI 6 capsules twice a day	Drug: ASHMI 6 capsules orally twice a day
2: Experimental ASHMI 2 capsules twice a day plus placebo 4 capsules twice a day	Drug: ASHMI 2 capsules orally twice a day
3: Placebo Comparator Placebo 6 capsules twice a day	Drug: Placebo Placebo 6 capsules twice a day

Detailed Description:

Asthma is a major public health problem worldwide, particularly in westernized societies and has continued to increase in prevalence over the past two decades. Inhaled corticosteroids have become the first-line treatment for persistent asthma even though side effects have been reported. New asthma medications, including leukotriene inhibitors and anti-IgE, have shown limited benefits. Patients have increasingly turned to complementary and alternative medicine (CAM) for treatment of their asthma, despite the uncertainty of its benefits due a lack of well-controlled scientific studies.

We have developed a Chinese herbal formula composed of 3 herbs called ASHMI. It has been previously shown in murine studies that ASHMI (a formula containing Ling Zhi, Ku Shen and Gan Cao) has therapeutic effects on the major pathogenic mechanisms of asthma-airway hyperreactivity, pulmonary inflammation, and airway remodeling, as well as a down-regulating of TH2 response. A subsequent study in 91 asthmatic patients in Weifang, China found ASHMI to be a safe and effective alternative to prednisone for treating asthma and exhibited a beneficial effect on TH1 and TH2 balance. Additionally, a Phase I study conducted in the United States showed good tolerability to ASHMI. Based on these preliminary studies, we hypothesize that ASHMI will be a safe medication in patients with asthma.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female subjects ages 18 through 55 and otherwise in good health as determined by medical history and physical examination
History of asthma documented by a physician for at least 6 months
Females of childbearing potential must be sexually inactive or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study
The subject agrees to participate in the study
Subjects must have one of the following:
one asthma-related unscheduled visit to an Emergency Department or clinic in the past 12 months
One overnight hospitalization in the past 12 months
Disturbed sleep more than twice in the past month
Asthma symptoms ≥8 times in the past month
use of a β2-agonist ≥8 times in the past month
two short courses (3-7 days) of oral corticosteroids in the last 12 months
FEV1 <80% predicted AND Use of inhaled corticosteroid (ICS) for at least 1 month prior to enrollment

Exclusion Criteria:

Acute illness (such as cold, flu, etc.) within two weeks before the screening visit
Any history of systemic disease that in the investigator's opinion would preclude the subject from participating in this study, including hepatitis virus infection
History of chronic obstructive lung disease, emphysema, or other chronic respiratory condition
Abnormal hepatic function (ALT/AST and bilirubin >1.25 x upper limit of normal)
Abnormal bone marrow function (WBC <4 x 103/mm3; platelets <100 x 103/mm3; Hgb <11 g/dl)
Abnormal renal function (BUN and creatinine >1.25 x upper limit of normal)
Clinically significant abnormal electrocardiogram
FEV1 <50% predicted
Participation in another experimental therapy study within 30 days of this study
History of alcohol or drug abuse
Pregnant or lactating female subjects. Females of childbearing potential will need a negative serum pregnancy test at screening to be considered for this study
Subjects receiving treatment with Omalizumab or immunotherapy for asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712296

Contacts

Contact: Juan P Wisnivesky, MD, MPH	212-2411799
Contact: Juan P Wisnivesky, MD	212-8247567	juan.wisnivesky@mssm.edu

Locations

United States, New York
Mount Sinai School of Medicine	Recruiting
New York, New York, United States, 10029
Contact: Juan P Wisnivesky, MD, MPH 212-824-7567 juan.wisnivesky@mssm.edu

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Juan P Wisnivesky, MD, MPH

Mount Sinai School of Medicine

More Information

Publications:

Wen MC, Wei CH, Hu ZQ, Srivastava K, Ko J, Xi ST, Mu DZ, Du JB, Li GH, Wallenstein S, Sampson H, Kattan M, Li XM. Efficacy and tolerability of anti-asthma herbal medicine intervention in adult patients with moderate-severe allergic asthma. J Allergy Clin Immunol. 2005 Sep;116(3):517-24.

Responsible Party:	Mount Sinai School of Medicine ( Xiu-Min Li, MD )
Study ID Numbers:	P01 AT002647_2, 5 P01 AT 002647-02
Study First Received:	July 7, 2008
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00712296
Health Authority:	United States: Food and Drug Administration; United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Asthma, alternative medicine, complementary medicine, herbal therapy

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 14, 2009