Safety Study of Chinese Herbal Therapy to Treat Asthma
关键词
抽象
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.
日期
| 最后验证: | 01/31/2012 |
| 首次提交: | 01/14/2008 |
| 提交的预估入学人数: | 01/14/2008 |
| 首次发布: | 01/27/2008 |
| 上次提交的更新: | 01/17/2018 |
| 最近更新发布: | 01/22/2018 |
| 实际学习开始日期: | 09/30/2006 |
| 预计主要完成日期: | 05/31/2008 |
| 预计完成日期: | 06/30/2008 |
状况或疾病
干预/治疗
Drug: Anti-Asthma Herbal Medical Intervention (ASHMI)
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: 1a Low dose ASHMI (2 caps bid). | |
| Placebo Comparator: 1b Placebo 2 caps bid. | |
| Active Comparator: 2a Medium dose ASHMI (4 caps bid). | |
| Placebo Comparator: 2b Placebo 4 caps bid. | |
| Active Comparator: 3a High dose ASHMI (6 caps bid). | |
| Placebo Comparator: 3b Placebo 6 caps bid. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
结果
主要结果指标
1. Drug safety (absence of severe adverse effects) [1 week]
次要成果指标
1. Clinically significant changes in electrocardiogram [1 week]
2. Clinically significant changes in blood count [1 week]
3. Clinically significant changes in serum chemistries [1 week]
4. Clinically significant changes in renal function [1 week]
5. Clinically significant changes in liver function [1 week]
6. Clinically significant changes in urinalysis [1 week]
7. Allergen-specific IgE levels [1 week]
8. Total IgA level [1 week]
9. T-cell cytokine profile [1 week]
10. Prostaglandin levels [1 week]
