Effectiveness of Chinese Herbal Therapy for Asthma

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT00712296

Run by

Icahn School of Medicine at Mount Sinai

People needed

66

Starts

2008-08-01

Expected to finish

2009-09-29

Last updated by the study team

2020-09-16

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.