SAFETY OF GANODERMA LUCIDUM EXTRACT

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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.