Alternative Therapies for Benign Prostatic Hyperplasia (CAMUS)

描述（由申请人提供）：该提案是12个提案中的一个，11个临床中心各一个，数据协调中心（DCC）一个，与NIDDK的CAMUS临床试验的持续资助有关，该试验正在研究Serenoa repens（锯棕榈）浆果提取物治疗良性前列腺增生（BPH）的有效性和安全性。12份提案中的每一份都包括在研究指导委员会的职权范围内准备的共同部分，然后是提交申请的中心的特定部分。这个特殊的应用是为加拿大安大略省金斯顿的女王大学临床中心提供的。该中心的详细信息从下面的公共部分开始。整个CAMUS试验（泌尿系统症状的补充和替代医学）功能齐全，正在顺利进行。由NIDDK、国家补充和替代医学中心（NCCAM）和膳食补充剂办公室（ODS）共同资助，它成功地随机分配了369名参与者，超过了最初目标的350名；然而，招募时间比最初预期的6个月要长，因此，协议规定的最后招募参与者的治疗期现在延长到了目前的资助期（截至2010年3月31日）之后。第一个参与者将于2009年12月完成后续工作，最后一个参与者将于2010年10月完成后续工作。因此，要求在一段额外时期内提供资金，以使所有CAMUS研究对象能够完成议定书中规定的72周后续行动，并允许进行适当的数据清理、分析和出版。CAMUS是一项随机、双盲、双组试验，共有369名参与者，大约平均分配到Serenoa repens提取物或安慰剂组，在连续24周的3个时间段内，剂量逐渐增加，开始是每天320毫克，然后是640毫克，然后是960毫克。参与者继续接受研究治疗，直到他们符合协议规定的停止治疗的原因或完成72周的治疗期。11个CAMUS临床中心于2008年6月5日开始招募，并于2009年4月17日成功完成369名受试者的随机化。

DESCRIPTION (provided by applicant): This proposal is one of 12, one for each of the 11 clinical centers plus one for the Data Coordinating Center (DCC), relevant to the continued funding of NIDDK's CAMUS clinical trial that is investigating the efficacy and safety of an extract of the berries of Serenoa repens (saw palmetto) for the treatment of benign prostrate hyperplasia (BPH). Each of the 12 proposals includes a common section prepared under the purview of the study's Steering Committee, followed by a section specific to the center submitting the application. This specific application is for the Clinical Center at the Queen's University at Kingston, Ontario Canada. Details for this center begin on page following the common section below. The overall CAMUS trial (Complementary and Alternative Medicine for Urological Symptoms) is fully functional and well underway. Funded jointly by NIDDK, the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplements (ODS), it has successfully randomized 369 participants, more than the 350 initially targeted; however, recruitment took longer than the six months initially expected so that the protocol specified treatment period for the last participants recruited now extends beyond the current funding period which ends March 31, 2010. The first participant is scheduled to complete follow-up in December, 2009 and the last in October, 2010. As a consequence, funding is requested for an additional period to permit ail CAMUS subjects to complete the 72 weeks of follow-up specified in the protocol and to allow for appropriate data clean up, analyses and publications. CAMUS is a randomized, double-blind, two arm trial with 369 participants, approximately equally allocated to either the Serenoa repens extract or placebo in escalating doses over three consecutive 24 weeks periods, beginning with 320 mg, then 640 mg, then and then 960 mg daily. Participants continue on study treatment until they meet a protocol defined reason for treatment discontinuation or complete the 72 week treatment period. The 11 CAMUS clinical centers initiated recruitment June 5, 2008 and successfully completed randomization of 369 subjects on April 17, 2009. PUBLIC HEALTH RELEVANCE: Statement not given.