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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: ASHMI Drug: Placebo | Phase 2 |
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 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 |
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
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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
|
- Number of patients whose asthma medication regimen (Inhaled corticosteroids) can be stepped down at least two levels [ Time Frame: 28 weeks ]
- Pulmonary function tests [ Time Frame: 12 weeks ]
- Asthma symptoms [ Time Frame: 12 weeks ]
- Asthma-related quality of life [ Time Frame: 12 weeks ]
- Airway hyperreactivity [ Time Frame: 28 weeks ]
- Acute asthma-related resource utilization [ Time Frame: 12 weeks ]
- Immunologic markers [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 |
Principal Investigator: | Juan P Wisnivesky, MD, MPH | Icahn School of Medicine at Mount Sinai |
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 |