Alternative Therapies for Benign Prostatic Hyperplasia (CAMUS)

描述(由申请人提供)：本提案是12个项目之一，11个临床中心各1个，数据协调中心(DCC)1个，与继续资助NIDDK的CAMU临床试验有关，该试验正在调查Serenoa riens(锯棕榈树)浆果提取物治疗良性前列腺增生症(BPH)的有效性和安全性。12项提案中的每一项都包括在研究指导委员会的职权范围内准备的共同部分，随后是提交申请的中心的特定部分。此特定应用程序适用于加拿大安大略省金斯敦女王大学的临床中心。关于该中心的详细信息开始于以下公共部分之后的第页。整个CAMU试验(治疗泌尿系统症状的补充和替代医学)功能齐全，进展顺利。在NIDDK、国家补充和替代医学中心(NCCAM)和膳食补充剂办公室(Ods)的联合资助下，它成功地随机选择了369名参与者，超过了最初的目标350人；然而，招募花费了比最初预期的6个月更长的时间，因此为最后招募的参与者指定的方案治疗期现在延长到目前的资助期之后，该资助期将于2010年3月31日结束。第一个参与者计划于2009年12月完成后续行动，最后一个参与者将于2010年10月完成后续行动。因此，需要为额外的时间提供资金，以便所有加缪受试者能够完成议定书规定的72周后续行动，并进行适当的数据清理、分析和出版。CAMU是一项随机、双盲、双臂试验，有369名参与者，在连续三个24周的期间内，大致平均分配给Serenoa epens提取物或安慰剂，剂量从320毫克开始，然后是640毫克，然后是每天960毫克。参与者继续接受研究治疗，直到他们达到规定的停止治疗的原因或完成72周的治疗周期。11个加缪临床中心于2008年6月5日开始招募，并于2009年4月17日成功完成了369名受试者的随机抽样。 与公共卫生相关：未发表声明。

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.