SAFETY OF GANODERMA LUCIDUM EXTRACT

灵芝提取物的安全性

• 批准号: 7378654
• 负责人: CHUN-SU YUAN
• 金额: $ 0.28万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-18 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378654
• 关键词: Basidiomycetes; China; anxiety; asthma; balance; blood tests; clinical trials; fatigue; health; human; immune system; immunity; immunodeficiency; lead; medicine; neoplasm /cancer; play; role; sleep disorders; stress

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The immune system plays an essential role in maintaining the body's overall health and resistance to disease. Certain factors may cause or trigger immune dysfunction leading to immune deficiency. Related to these events is the development of cancer, a notion supported by the fact that patients with immunodeficiency, or immunosuppressed transplant recipients, show a greater incidence of cancer. Ganoderma lucidum (a medical mushroom) is a Chinese herb widely used for different purposes, such as in balancing immunity and treating anxiety, stress, arthritis, allergic asthma, bronchitis, insomnia, chronic fatigue, and cardiovascular problems. The herb is also often a main ingredient in traditional Chinese medicine herbal formulations for immune dysfunction illnessess. SunRecome is the trade name of the Ganoderma lucidum extract product, which was approved as a drug by the Chinese State Drug Administration in 2002. In the past several years, SunRecome has been used in thousands of patients in China without any significant adverse effects. This Phase I study is designed to test the hypothesis that oral Ganoderma lucidum extract (U.S. FDA IND #71,810) is safe to use in human volunteers. The following are specific aims: 1. To evaluate tolerance and safety of oral Ganoderma lucidum extract in humans. 2. To evaluate effects of Ganoderma lucidum extract on blood tests reflecting immunity. Successful completion of this Phase I study will lead to future clinical trials to evaluate the efficacy of this medical herb in a number of indications.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。免疫系统在维持身体的整体健康和抵抗疾病方面起着至关重要的作用。某些因素可能导致或触发免疫功能障碍，导致免疫缺陷。与这些事件相关的是癌症的发展，免疫缺陷患者或免疫抑制移植接受者显示出更高的癌症发病率这一事实支持了这一观点。灵芝（一种药用蘑菇）是一种广泛用于不同目的的中药，如平衡免疫和治疗焦虑、压力、关节炎、过敏性哮喘、支气管炎、失眠、慢性疲劳和心血管问题。这种草药也经常是用于治疗免疫功能障碍疾病的传统中药配方的主要成分。SunRecome是灵芝提取物产品的商品名，于2002年被中国国家药品监督管理局批准为药品。在过去的几年里，SunRecome已经在中国使用了数千名患者，没有任何明显的不良反应。这项I期研究旨在验证口服灵芝提取物（U.S. FDA IND # 71810）在人类志愿者中使用是安全的假设。具体目标如下：评价口服灵芝提取物对人体的耐受性和安全性。2. 评价灵芝提取物对血液免疫指标的影响。I期研究的成功完成将导致未来的临床试验，以评估该草药在许多适应症中的功效。