SAFETY OF GANODERMA LUCIDUM EXTRACT

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。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，这一概念得到以下事实的支持，即免疫缺陷患者或免疫抑制的移植受体显示出更高的癌症发病率。 灵芝（一种药用蘑菇）是一种中草药，广泛用于不同的目的，如平衡免疫力和治疗焦虑，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。该草药也经常是用于免疫功能障碍疾病的传统中药草药配方的主要成分。SunRecome是灵芝提取物产品的商品名，该产品于2002年被中国国家药品监督管理局批准为药物。在过去的几年里，SunRecome已在中国数千名患者中使用，没有任何明显的不良反应。这项I期研究旨在检验口服灵芝提取物（美国FDA IND #71，810）在人类志愿者中使用安全的假设。具体目标如下：1.评价口服灵芝提取物的人体耐受性和安全性。2.探讨灵芝提取物对反映免疫功能的血液指标的影响。这项I期研究的成功完成将导致未来的临床试验，以评估这种草药在许多适应症中的疗效。

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.