Safety Study of Chinese Herbal Therapy to Treat Asthma

NCT ID: NCT00601263

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-07-31

Brief 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.

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 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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1a

Low dose ASHMI (2 caps bid).

Group Type: ACTIVE_COMPARATOR

Anti-Asthma Herbal Medical Intervention (ASHMI)

Intervention Type: DRUG

We propose to test 3 daily doses in which 2,4, or 6 ASHMI or placebo capsules will be administered orally twice daily (BID) for 7 days.

1b

Placebo 2 caps bid.

Group Type: PLACEBO_COMPARATOR

Anti-Asthma Herbal Medical Intervention (ASHMI)

Intervention Type: DRUG

We propose to test 3 daily doses in which 2,4, or 6 ASHMI or placebo capsules will be administered orally twice daily (BID) for 7 days.

2a

Medium dose ASHMI (4 caps bid).

Group Type: ACTIVE_COMPARATOR

Anti-Asthma Herbal Medical Intervention (ASHMI)

Intervention Type: DRUG

We propose to test 3 daily doses in which 2,4, or 6 ASHMI or placebo capsules will be administered orally twice daily (BID) for 7 days.

2b

Placebo 4 caps bid.

Group Type: PLACEBO_COMPARATOR

Anti-Asthma Herbal Medical Intervention (ASHMI)

Intervention Type: DRUG

We propose to test 3 daily doses in which 2,4, or 6 ASHMI or placebo capsules will be administered orally twice daily (BID) for 7 days.

3a

High dose ASHMI (6 caps bid).

Group Type: ACTIVE_COMPARATOR

Anti-Asthma Herbal Medical Intervention (ASHMI)

Intervention Type: DRUG

We propose to test 3 daily doses in which 2,4, or 6 ASHMI or placebo capsules will be administered orally twice daily (BID) for 7 days.

3b

Placebo 6 caps bid.

Group Type: PLACEBO_COMPARATOR

Anti-Asthma Herbal Medical Intervention (ASHMI)

Intervention Type: DRUG

We propose to test 3 daily doses in which 2,4, or 6 ASHMI or placebo capsules will be administered orally twice daily (BID) for 7 days.

Interventions

Anti-Asthma Herbal Medical Intervention (ASHMI)

We propose to test 3 daily doses in which 2,4, or 6 ASHMI or placebo capsules will be administered orally twice daily (BID) for 7 days.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Xiu-Min Li

OTHER

Sponsor Role: lead

Responsible Party

Xiu-Min Li

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Juan Wisnivesky, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai School Medicine

New York, New York, United States

Countries

United States

References

Wen MC, Wei CH, Hu ZQ, Srivastava K, Ko J, Xi ST, Mu DZ, Du JB, Li GH, Wallenstein S, Sampson H, Kattan M, Li XM. Efficacy and tolerability of anti-asthma herbal medicine intervention in adult patients with moderate-severe allergic asthma. J Allergy Clin Immunol. 2005 Sep;116(3):517-24. doi: 10.1016/j.jaci.2005.05.029.

Reference Type: BACKGROUND

PMID: 16159618 (View on PubMed)

Other Identifiers

P01AT002647

Identifier Type: NIH

Identifier Source: secondary_id

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GCO 04-0206

Identifier Type: -

Identifier Source: secondary_id

P01AT002647

Identifier Type: NIH

Identifier Source: org_study_id

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