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| ID | Type | Description | Link |
|---|---|---|---|
| P01AT002647-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The purpose of this study is to determine the efficacy of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASHMI 4 | Experimental | ASHMI 4 capsules twice a day |
|
| ASHMI 12 | Experimental | ASHMI 12 capsules twice a day |
|
| Placebo | Placebo Comparator | Placebo 6 capsules twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASHMI 4 | Drug | 4 capsules orally twice a day |
| |
| ASHMI 12 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan P Wisnivesky, MD, DrPH | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16159618 | Background | 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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Phase I: Time frame 1 week; Phase II: Time frame 28 weeks. Participants from Phase I were invited to participate in Phase II and were re-randomized to all three arms of Phase II.
Recruitment Period: 10/5/2006-3/12/2010
Location: Mount Sinai School of Medicine, New York, NY
Phase I Participants Screened 55 Consented 35 Excluded 13 Withdrawn 2
Phase II Participants Screened 183 Consented 76 Excluded 19 Screen failed 11
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| ID | Title | Description |
|---|---|---|
| FG000 | Active, Phase I | Patients received 3 daily doses in which 2, 4 or 6 ASHMI capsules were administered twice a day for 7 days. |
| FG001 | Placebo, Phase I | Patients received placebo. (phase I) |
| FG002 | Active Phase II (ASHMI 4 Caps) | Patients received active drug. 4 caps twice a day. |
| FG003 | Active, Phase II (ASHMI 12 Caps ) | Patients received active drug. 12 caps twice a day. |
| FG004 | Placebo, Phase II | Patients received placebo. (phase II) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I ( 1 Week) |
| |||||||||||||
| Phase II (28 Weeks) |
|
ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active, Phase I | Patients received 3 daily doses in which 2, 4, or 6 ASHMI capsules were administered twice a day for 7 days. |
| BG001 | Placebo, Phase I | Patients received placebo. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | For the Phase I study we used descriptive statistics to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat. | Posted | Jul 2011 | Mean | Standard Deviation | mg/dL | 1 week after receiving active drug or placebo |
|
Phase I: 1 week Phase II: 28 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Phase I (ASHMI 2 Caps Twice a Day) | Patients received 2, 4, or 6 ASHMI capsules were administered twice daily for 7 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
The Phase II study was stopped after 46 subjects were randomized. Since the number of subjects and the follow-up information did not provide adequate power, all statistical analysis plan was changed to descriptive summaries for each group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xiu-Min Li, MD | Icahn School of Medicine at Mount Sinai | 212-241-1755 | Xiu-min.li@mssm.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Drug |
12 capsules orally twice a day |
|
| Placebo | Drug | Placebo 6 capsules twice a day |
|
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Active, Phase II (ASHMI 4 Caps ) | Patients received active drug, 4 caps twice a day |
| BG003 | Active, Phase II (ASHMI 12 Caps) | Patients received active drug, 12 caps twice a day |
| BG004 | Placebo, Phase II | Patients received placebo. |
| BG005 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | This includes the number of males and females for the randomized study population for Phase I and Phase II | ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II. | Number | participants |
|
| OG002 | Placebo Phase I Baseline | Baseline results for participants who received placebo. |
| OG003 | Placebo Phase I Post Treatment | Post Treatment results for participants who received placebo. |
|
|
| Primary | 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 | For the Phase I study we used descriptive statistics to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat. | Posted | Jul 2011 | Mean | Standard Deviation | meq/L | 1 week after receiving active drug or placebo |
|
|
|
| Primary | 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 | For the Phase I study we used descriptive statistics to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat. | Posted | Mean | Standard Deviation | IU/L | 1 week after receiving active drug and placebo |
|
|
|
| Primary | 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 | For the Phase I study we used descriptive statistics to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat. | Posted | Mean | Standard Deviation | cells*10^3/uL | 1 week after receiving active drug and placebo |
|
|
|
| Primary | Hemoglobin Laboratory Results in Phase I | Summary of hemoglobin as Outcome measures included laboratory data for subjects enrolled in Phase 1 | For the Phase I study descriptive statistics were used to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat. | Posted | Mean | Standard Deviation | g/dL | 1 week |
|
|
|
| Primary | 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 | The Phase II study was terminated in September 2009 before the planned enrollment of 50 subjects was completed. As of September 29, 2009, the trial was discontinued in accordance with recommendations of the Data Safety Monitoring Board (DSMB). | Posted | Sep 2011 | Mean | Standard Deviation | mg/dL | 28 weeks |
|
|
|
| Primary | 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 | The Phase II study was terminated in September 2009 before the planned enrollment of 50 subjects was completed. | Posted | Jun 2011 | Mean | Standard Deviation | meq/L | 28 weeks |
|
|
|
| Primary | 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 | The Phase II study was terminated in September 2009 before the planned enrollment of 50 subjects was completed. As of September 28, 2009, the trial was discontinued in accordance with recommendations of the Data Safety Monitoring Board (DSMB). | Posted | Jun 2011 | Mean | Standard Deviation | IU/L | 28 weeks |
|
|
|
| Primary | 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 | The Phase II study was terminated in September 2009 before the planned enrollment of 50 subjects was completed. As of September 28, 2009,the trial was discontinued in accordance with recommendations of the Data Safety Monitoring Board (DSMB). | Posted | Jun 2011 | Mean | Standard Deviation | cells*10^3/uL | 28 weeks |
|
|
|
| Primary | 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 | The Phase II study was terminated in September 2009 before the planned enrollment of 50 subjects was completed. As of September 28, 2009, the trial was discontinued in accordance with recommendations of the Data Safety Monitoring Board (DSMB). | Posted | Jun 2011 | Mean | Standard Deviation | g/dL | 28 weeks |
|
|
|
| 0 |
| 4 |
| 2 |
| 4 |
| EG001 | Placebo Phase I (2 Caps Twice a Day) | Patients received placebo. 2 caps twice a day. | 0 | 2 | 2 | 2 |
| EG002 | Active Phase I (ASHMI 4 Caps) | Patients received active drug. 4 caps twice a day. | 0 | 4 | 1 | 4 |
| EG003 | Placebo Phase I (4 Caps Twice a Day) | Patients received placebo. 4 caps twice a day. | 0 | 4 | 2 | 4 |
| EG004 | Active Phase I (ASHMI 6 Caps) | Patients received active drug. 6 caps twice a day. | 0 | 4 | 1 | 4 |
| EG005 | Placebo Phase I | Patients received placebo. | 0 | 2 | 1 | 2 |
| EG006 | Active Phase II (ASHMI 4 Caps Twice a Day) | Patients received active drug.Based on revised adverse event criteria on January 2010. | 0 | 15 | 2 | 15 |
| EG007 | Active Phase II (ASHMI 12 Caps) | Patients received active drug. 12 caps twice a day. | 0 | 16 | 2 | 16 |
| EG008 | Placebo Phase II | Patients received placebo. | 0 | 15 | 3 | 15 |
| Increased Thirst | General disorders | Systematic Assessment |
|
| Body aches and fatigue associated with subject's typical prementrual syndrome | General disorders | Systematic Assessment |
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| Transient upper extremity itchiness | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Decreased total serum bicarbonate level | General disorders | Systematic Assessment |
|
| Back muscle injury | General disorders | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Glucosuria | General disorders | Systematic Assessment |
|
| Decreased Glucose Level | General disorders | Systematic Assessment |
|
| Decreased Hemoglobin Level | General disorders | Systematic Assessment |
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| Decreased White Blood Cell Count | General disorders | Systematic Assessment |
|
| Emergency room visit for asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Unscheduled physician visit for asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Electrocardiogram changes | Cardiac disorders | Systematic Assessment |
|
| Trichomonas in urine | Renal and urinary disorders | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | Systematic Assessment |
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| Increased Alkaline Phosphatase | Renal and urinary disorders | Systematic Assessment |
|
| Increased Creatine | Renal and urinary disorders | Systematic Assessment |
|
| Gastrointestinal symptoms | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Elevated Liver Enzymes | Gastrointestinal disorders | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Potassium (meq/L) |
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| Chloride (meq/L) |
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| Carbon dioxide (meq/L) |
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| Serum glutamic oxaloacetic transaminase (SGOT) |
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| Platelet |
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| Urea |
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| Creatinine |
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| Bilirubin Total |
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| Bilirubin Direct |
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| Potassium |
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| Chloride |
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| Bicarbonate |
|
| Serum glutamic pyruvic transaminase (SGPT) |
|
| Serum glutamic oxaloacetic transaminase (SGOT) |
|
| Platelet |
|