Safety Study of Chinese Herbal Therapy to Treat Asthma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00601263
First received: January 15, 2008
Last updated: December 29, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Center for Chinese Herbal Therapy for Asthma. Project #2-Clinical Effect of a Chinese Herbal Therapy in Human Asthma-Phase I

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Drug safety (absence of severe adverse effects) [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinically significant changes in electrocardiogram [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Clinically significant changes in blood count [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Clinically significant changes in serum chemistries [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Clinically significant changes in renal function [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Clinically significant changes in liver function [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Clinically significant changes in urinalysis [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Allergen-specific IgE levels [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Total IgA level [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • T-cell cytokine profile [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Prostaglandin levels [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: October 2006
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601263

Locations
United States, New York
Mount Sinai School Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Juan Wisnivesky, MD, MPH Mount Sinai School of Medicine
  More Information

Publications:
Responsible Party: Xiu-Min Li, MD, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00601263     History of Changes
Other Study ID Numbers: P01 AT002647, P01AT002647, GCO 04-0206
Study First Received: January 15, 2008
Last Updated: December 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
Chinese Herbal Therapy
Asthma
Investigational new drug (IND)
Complementary and Alternative Medicine

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014