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Effectiveness of Chinese Herbal Therapy for Asthma

Primary Purpose

Asthma

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ASHMI 4

ASHMI 12

Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, alternative medicine, complementary medicine, herbal therapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

ASHMI 4

ASHMI 12

Placebo

Arm Description

ASHMI 4 capsules twice a day

ASHMI 12 capsules twice a day

Placebo 6 capsules twice a day

Outcomes

Primary Outcome Measures

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

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

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

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

Hemoglobin Laboratory Results in Phase I

Summary of hemoglobin as Outcome measures included laboratory data for subjects enrolled in Phase 1

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

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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00712296

First Posted

July 7, 2008

Last Updated

August 31, 2020

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT00712296

Brief Title

Effectiveness of Chinese Herbal Therapy for Asthma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Terminated

Study Start Date

August 2008 (Actual)

Primary Completion Date

September 29, 2009 (Actual)

Study Completion Date

September 29, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, alternative medicine, complementary medicine, herbal therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ASHMI 4

Arm Type

Experimental

Arm Description

ASHMI 4 capsules twice a day

Arm Title

ASHMI 12

Arm Type

Experimental

Arm Description

ASHMI 12 capsules twice a day

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo 6 capsules twice a day

Intervention Type

Drug

Intervention Name(s)

ASHMI 4

Intervention Description

4 capsules orally twice a day

Intervention Type

Drug

Intervention Name(s)

ASHMI 12

Intervention Description

12 capsules orally twice a day

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo 6 capsules twice a day

Primary Outcome Measure Information:

Title

Glucose, Urea and Creatinine Phase I

Description

Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL) and Creatinine(mg/dL) in subjects enrolled in Phase 1

Time Frame

1 week after receiving active drug or placebo

Title

Sodium, Potassium, Chloride and CO2 Phase I

Description

Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and CO2 (meq/L) in subjects enrolled in Phase 1

Time Frame

1 week after receiving active drug or placebo

Title

Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I

Description

Summary of Laboratory data for Serum glutamic pyruvic transaminase and Serum glutamic oxaloacetic transaminase in subjects enrolled in Phase 1

Time Frame

1 week after receiving active drug and placebo

Title

Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I

Description

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

Time Frame

1 week after receiving active drug and placebo

Title

Hemoglobin Laboratory Results in Phase I

Description

Summary of hemoglobin as Outcome measures included laboratory data for subjects enrolled in Phase 1

Time Frame

1 week

Title

Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study

Description

Time Frame

28 weeks

Title

Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study

Description

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

Time Frame

28 weeks

Title

Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study

Description

Time Frame

28 weeks

Title

Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study

Description

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

Time Frame

28 weeks

Title

Laboratory Results for Hemoglobin in Subjects in Phase II Study

Description

Summary of Laboratory data for hemoglobin(g/dL)in subjects in Phase II study. Limited to Measurements before discontinuation of ASHMI treatment

Time Frame

28 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan P Wisnivesky, MD, DrPH

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16159618

Citation

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.

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Effectiveness of Chinese Herbal Therapy for Asthma

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