Center for Chinese Herbal Therapy for Asthma. Project #2-Clinical Effect of a Chinese Herbal Therapy in Human Asthma-Phase I
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Drug safety (absence of severe adverse effects)
研究概览
简要总结
The purpose of this study is to determine the safety of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics and to see what effects ASHMI has on certain parts of the immune system.
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 significant side effects have been reported. New asthma medications, including leukotriene inhibitors and anti-IgE, have shown only marginal 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. Based on these preliminary studies, we hypothesize that ASHMI will be a safe medication in atopic patients with asthma and will lead to identifiable changes in serum immunologic markers.
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 18-40 and otherwise in good health as determined by medical history and physical examination
- •History of asthma documented by a physician
- •Documentation of allergy to two or more common environmental allergens as evidenced by positive prick skin or RAST testing
- •The subject agrees to participate in the study
- •Females of childbearing potential must be inactive sexually or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study.
排除标准
- •Acute illness (such as cold, flu, etc.) within one week before the administration of study drug
- •Any history of systemic disease that in the investigator's opinion would preclude the subject from participating in this study, including viral hepatitis infection (by patient self-report)
- •Abnormal hepatic function
- •Abnormal bone marrow function
- •Abnormal renal function
- •Clinically significant abnormal electrocardiogram
- •Current uncontrolled moderate to severe asthma with FEV1 <80% predicted
- •Participation in another experimental study within 30 days of this study
- •History of alcohol or drug abuse (by self report)
- •Pregnant or lactating female subjects. Females of childbearing potential will need a negative serum pregnancy test to be considered for this study
- •Current smokers
研究组 & 干预措施
1a
Low dose ASHMI (2 caps bid).
干预措施: Anti-Asthma Herbal Medical Intervention (ASHMI) (Drug)
1b
Placebo 2 caps bid.
干预措施: Anti-Asthma Herbal Medical Intervention (ASHMI) (Drug)
2a
Medium dose ASHMI (4 caps bid).
干预措施: Anti-Asthma Herbal Medical Intervention (ASHMI) (Drug)
2b
Placebo 4 caps bid.
干预措施: Anti-Asthma Herbal Medical Intervention (ASHMI) (Drug)
3a
High dose ASHMI (6 caps bid).
干预措施: Anti-Asthma Herbal Medical Intervention (ASHMI) (Drug)
3b
Placebo 6 caps bid.
干预措施: Anti-Asthma Herbal Medical Intervention (ASHMI) (Drug)
结局指标
主要结局
Drug safety (absence of severe adverse effects)
时间窗: 1 week
次要结局
- Clinically significant changes in serum chemistries(1 week)
- Clinically significant changes in liver function(1 week)
- Prostaglandin levels(1 week)
- Clinically significant changes in blood count(1 week)
- Allergen-specific IgE levels(1 week)
- Clinically significant changes in renal function(1 week)
- Clinically significant changes in electrocardiogram(1 week)
- T-cell cytokine profile(1 week)
- Clinically significant changes in urinalysis(1 week)
- Total IgA level(1 week)
研究者
Xiu-Min Li
Principal Investigator
Icahn School of Medicine at Mount Sinai