Status:
TERMINATED
Effectiveness of Chinese Herbal Therapy for Asthma
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the efficacy of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2009
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00712296
Start Date
August 1 2008
End Date
September 29 2009
Last Update
September 16 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029