Safety Study of Chinese Herbal Therapy to Treat Asthma

Center for Chinese Herbal Therapy for Asthma. Project #2-Clinical Effect of a Chinese Herbal Therapy in Human Asthma-Phase I

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1a; Low dose ASHMI (2 caps bid).	Drug: 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.
Placebo Comparator: 1b; Placebo 2 caps bid.	Drug: 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.
Active Comparator: 2a; Medium dose ASHMI (4 caps bid).	Drug: 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.
Placebo Comparator: 2b; Placebo 4 caps bid.	Drug: 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.
Active Comparator: 3a; High dose ASHMI (6 caps bid).	Drug: 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.
Placebo Comparator: 3b; Placebo 6 caps bid.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Drug safety (absence of severe adverse effects)	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinically significant changes in electrocardiogram	1 week
Clinically significant changes in blood count	1 week
Clinically significant changes in serum chemistries	1 week
Clinically significant changes in renal function	1 week
Clinically significant changes in liver function	1 week
Clinically significant changes in urinalysis	1 week
Allergen-specific IgE levels	1 week
Total IgA level	1 week
T-cell cytokine profile	1 week
Prostaglandin levels	1 week

Collaborators and Investigators

• Sponsor: Xiu-Min Li
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: January 15, 2008
• First Submitted That Met QC Criteria: January 15, 2008
• First Posted (Estimate): January 28, 2008

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Asthma; Complementary and Alternative Medicine; Chinese Herbal Therapy; Investigational new drug (IND)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: P01AT002647 (U.S. NIH Grant/Contract); GCO 04-0206