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Effectiveness of Chinese Herbal Therapy for Asthma

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ClinicalTrials.gov Identifier: NCT00712296
Recruitment Status : Suspended
First Posted : July 9, 2008
Last Update Posted : December 30, 2009
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by:
Icahn School of Medicine at Mount Sinai

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

Condition or disease Intervention/treatment Phase
Asthma Drug: ASHMI Drug: Placebo Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Center for Chinese Herbal Therapy for Asthma. Project #2-Clinical Effect of a Chinese Herbal Therapy in Human Asthma-Phase II
Study Start Date : August 2008
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : July 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
ASHMI 6 capsules twice a day
 Drug: ASHMI
6 capsules orally twice a day
Experimental: 2
ASHMI 2 capsules twice a day plus placebo 4 capsules twice a day
 Drug: ASHMI
2 capsules orally twice a day
Placebo Comparator: 3
Placebo 6 capsules twice a day
 Drug: Placebo
Placebo 6 capsules twice a day


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients whose asthma medication regimen (Inhaled corticosteroids) can be stepped down at least two levels [ Time Frame: 28 weeks ]

Secondary Outcome Measures :
  1. Pulmonary function tests [ Time Frame: 12 weeks ]
  2. Asthma symptoms [ Time Frame: 12 weeks ]
  3. Asthma-related quality of life [ Time Frame: 12 weeks ]
  4. Airway hyperreactivity [ Time Frame: 28 weeks ]
  5. Acute asthma-related resource utilization [ Time Frame: 12 weeks ]
  6. Immunologic markers [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712296


Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Juan P Wisnivesky, MD, MPH Icahn School of Medicine at Mount Sinai
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Xiu-Min Li, MD, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00712296     History of Changes
Other Study ID Numbers: P01 AT002647-2
P01AT002647-02 ( U.S. NIH Grant/Contract )
5P01AT002647-02 ( U.S. NIH Grant/Contract )
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: December 30, 2009
Last Verified: December 2009

Keywords provided by Icahn School of Medicine at Mount Sinai:
Asthma
alternative medicine
complementary medicine
herbal therapy

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