Effectiveness of Chinese Herbal Therapy for Asthma

NCT ID: NCT00712296

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-09-29

Brief Summary

The purpose of this study is to determine the efficacy of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics

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 side effects have been reported. New asthma medications, including leukotriene inhibitors and anti-IgE, have shown limited 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. Additionally, a Phase I study conducted in the United States showed good tolerability to ASHMI. Based on these preliminary studies, we hypothesize that ASHMI will be a safe medication in patients with asthma.

Conditions

Asthma

Study Design

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

Study Groups

ASHMI 4

ASHMI 4 capsules twice a day

Group Type: EXPERIMENTAL

ASHMI 4

Intervention Type: DRUG

4 capsules orally twice a day

ASHMI 12

ASHMI 12 capsules twice a day

Group Type: EXPERIMENTAL

ASHMI 12

Intervention Type: DRUG

12 capsules orally twice a day

Placebo

Placebo 6 capsules twice a day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 6 capsules twice a day

Interventions

ASHMI 4

4 capsules orally twice a day

Intervention Type: DRUG

ASHMI 12

12 capsules orally twice a day

Intervention Type: DRUG

Placebo

Placebo 6 capsules twice a day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female subjects ages 18 through 55 and otherwise in good health as determined by medical history and physical examination
• History of asthma documented by a physician for at least 6 months
• Females of childbearing potential must be sexually inactive or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study
• The subject agrees to participate in the study
• Subjects must have one of the following:
• one asthma-related unscheduled visit to an Emergency Department or clinic in the past 12 months
• One overnight hospitalization in the past 12 months
• Disturbed sleep more than twice in the past month
• Asthma symptoms ≥8 times in the past month
• use of a β2-agonist ≥8 times in the past month
• two short courses (3-7 days) of oral corticosteroids in the last 12 months
• FEV1 <80% predicted AND Use of inhaled corticosteroid (ICS) for at least 1 month prior to enrollment

Exclusion Criteria

• Acute illness (such as cold, flu, etc.) within two weeks before the screening visit
• Any history of systemic disease that in the investigator's opinion would preclude the subject from participating in this study, including hepatitis virus infection
• History of chronic obstructive lung disease, emphysema, or other chronic respiratory condition
• Abnormal hepatic function (ALT/AST and bilirubin >1.25 x upper limit of normal)
• Abnormal bone marrow function (WBC <4 x 103/mm3; platelets <100 x 103/mm3; Hgb <11 g/dl)
• Abnormal renal function (BUN and creatinine >1.25 x upper limit of normal)
• Clinically significant abnormal electrocardiogram
• FEV1 <50% predicted
• Participation in another experimental therapy study within 30 days of this study
• History of alcohol or drug abuse
• Pregnant or lactating female subjects. Females of childbearing potential will need a negative serum pregnancy test at screening to be considered for this study
• Subjects receiving treatment with Omalizumab or immunotherapy for asthma

• 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

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Xiu-Min Li

Professor, Pediatrics, Allergy and Immunology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan P Wisnivesky, MD, DrPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

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

P01AT002647-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 04-0206

Identifier Type: -

Identifier Source: org_study_id