Safety Study of Chinese Herbal Therapy to Treat Asthma

Xiu-Min Li

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00601263

P01AT002647 (U.S. NIH Grant/Contract)

GCO 04-0206

Details and patient eligibility

About

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.

Full 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 significant side effects have been reported. New asthma medications, including leukotriene inhibitors and anti-IgE, have shown only marginal 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. Based on these preliminary studies, we hypothesize that ASHMI will be a safe medication in atopic patients with asthma and will lead to identifiable changes in serum immunologic markers.

Enrollment: 35 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 6 patient groups, including a placebo group

1a

Active Comparator group

Description:

Low dose ASHMI (2 caps bid).

Treatment:

Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)

1b

Placebo Comparator group

Description:

Placebo 2 caps bid.

Treatment:

Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)

2a

Active Comparator group

Description:

Medium dose ASHMI (4 caps bid).

Treatment:

Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)

2b

Placebo Comparator group

Description:

Placebo 4 caps bid.

Treatment:

Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)

3a

Active Comparator group

Description:

High dose ASHMI (6 caps bid).

Treatment:

Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)

3b

Placebo Comparator group

Description:

Placebo 6 caps bid.

Treatment:

Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)