Safety Study of Chinese Herbal Therapy to Treat Asthma

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics and to see what effects ASHMI has on certain parts of the immune system.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai; Xiu-Min Li
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)

Criteria

Inclusion Criteria:

• Male and female subjects ages 18-40 and otherwise in good health as determined by medical history and physical examination

• History of asthma documented by a physician

• Documentation of allergy to two or more common environmental allergens as evidenced by positive prick skin or RAST testing

• The subject agrees to participate in the study

• Females of childbearing potential must be inactive sexually or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study.

Exclusion Criteria:

• Acute illness (such as cold, flu, etc.) within one week before the administration of study drug

• Any history of systemic disease that in the investigator's opinion would preclude the subject from participating in this study, including viral hepatitis infection (by patient self-report)

• Abnormal hepatic function

• Abnormal bone marrow function

• Abnormal renal function

• Clinically significant abnormal electrocardiogram

• Current uncontrolled moderate to severe asthma with FEV1 <80% predicted

• Participation in another experimental study within 30 days of this study

• History of alcohol or drug abuse (by self report)

• Pregnant or lactating female subjects. Females of childbearing potential will need a negative serum pregnancy test to be considered for this study

• Current smokers