Effectiveness of Chinese Herbal Therapy for Asthma

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

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

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Drug: ASHMI 4; Drug: ASHMI 12; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASHMI 4; ASHMI 4 capsules twice a day	Drug: ASHMI 4; 4 capsules orally twice a day
Experimental: ASHMI 12; ASHMI 12 capsules twice a day	Drug: ASHMI 12; 12 capsules orally twice a day
Placebo Comparator: Placebo; Placebo 6 capsules twice a day	Drug: Placebo; Placebo 6 capsules twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose, Urea and Creatinine Phase I	Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL) and Creatinine(mg/dL) in subjects enrolled in Phase 1	1 week after receiving active drug or placebo
Sodium, Potassium, Chloride and CO2 Phase I	Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and CO2 (meq/L) in subjects enrolled in Phase 1	1 week after receiving active drug or placebo
Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I	Summary of Laboratory data for Serum glutamic pyruvic transaminase and Serum glutamic oxaloacetic transaminase in subjects enrolled in Phase 1	1 week after receiving active drug and placebo
Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I	Summary of Laboratory data for White Blood Cell(cells*10^3/uL), Hemoglobin(cells*10^3/uL) and Platelet(cells*10^3/uL)in subjects enrolled in Phase 1	1 week after receiving active drug and placebo
Hemoglobin Laboratory Results in Phase I	Summary of hemoglobin as Outcome measures included laboratory data for subjects enrolled in Phase 1	1 week
Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study	Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL), Creatinine(mg/dL), Bilirubin Total(mg/dL) and Bilirubin Direct(mg/dL)in subjects in Phase II Limited to Measurements before discontinuation of ASHMI treatment	28 weeks
Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study	Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and Bicarbonate(meq/L)in subjects in Phase II Limited to Measurements before discontinuation of ASHMI treatment	28 weeks
Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study	Summary of Laboratory data for Alkaline phosphatase(IU/L),Serum glutamic pyruvic transaminase(IU/L)and Serum glutamic oxaloacetic transaminase(IU/L) in subjects in Phase II study Limited to Measurements before discontinuation of ASHMI treatment	28 weeks
Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study	Summary of Laboratory data for White Blood Cell Count(cells*10^3/uL) and Platelet (cells*10^3/uL)in Phase II study Limited to Measurements before discontinuation of ASHMI treatment	28 weeks
Laboratory Results for Hemoglobin in Subjects in Phase II Study	Summary of Laboratory data for hemoglobin(g/dL)in subjects in Phase II study. Limited to Measurements before discontinuation of ASHMI treatment	28 weeks

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Juan P Wisnivesky, MD, DrPH, Icahn School of Medicine at Mount Sinai

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 (Actual): August 1, 2008
• Primary Completion (Actual): September 29, 2009
• Study Completion (Actual): September 29, 2009

Study Registration Dates

• First Submitted: July 7, 2008
• First Submitted That Met QC Criteria: July 7, 2008
• First Posted (Estimate): July 9, 2008

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Asthma; complementary medicine; alternative medicine; herbal therapy
• 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: GCO 04-0206; P01AT002647-02 (U.S. NIH Grant/Contract)