Center for Chinese Herbal Therapy for Asthma. Project #2-Clinical Effect of a Chinese Herbal Therapy in Human Asthma-Phase II
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Glucose, Urea and Creatinine Phase I
研究概览
简要总结
The purpose of this study is to determine the efficacy of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ASHMI 4
ASHMI 4 capsules twice a day
干预措施: ASHMI 4 (Drug)
ASHMI 12
ASHMI 12 capsules twice a day
干预措施: ASHMI 12 (Drug)
Placebo
Placebo 6 capsules twice a day
干预措施: Placebo (Drug)
结局指标
主要结局
Glucose, Urea and Creatinine Phase I
时间窗: 1 week after receiving active drug or placebo
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
时间窗: 1 week after receiving active drug or placebo
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
时间窗: 1 week after receiving active drug and placebo
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
时间窗: 1 week after receiving active drug and placebo
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
时间窗: 1 week
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
时间窗: 28 weeks
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
时间窗: 28 weeks
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
时间窗: 28 weeks
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
时间窗: 28 weeks
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
时间窗: 28 weeks
Summary of Laboratory data for hemoglobin(g/dL)in subjects in Phase II study. Limited to Measurements before discontinuation of ASHMI treatment
次要结局
未报告次要终点
研究者
Xiu-Min Li
Professor, Pediatrics, Allergy and Immunology
Icahn School of Medicine at Mount Sinai