Alternative Therapies for Benign Prostatic Hyperplasia (CAMUS)

良性前列腺增生 (CAMUS) 的替代疗法

• 批准号: 7990688
• 负责人: JOHN CURTIS NICKEL
• 金额: $ 7.25万
• 依托单位: QUEEN'S UNIVERSITY AT KINGSTON
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7990688
• 关键词: Alternative Therapies; Benign; Benign Prostatic Hypertrophy; Berry; Blood Chemical Analysis; Canada; Chronic Prostatitis; Clinical; Clinical Trials; Complementary and alternative medicine; Complete Blood Count; Data; Data Coordinating Center; Data Set; Dose; Double-Blind Method; Functional disorder; Funding; Hyperplasia; Incontinence; Measures; National Center for Complementary and Alternative Medicine; National Institute of Diabetes and Digestive and Kidney Diseases; Nickel; Nocturia; Ontario; Paper; Participant; Placebos; Principal Investigator; Prostate-Specific Antigen; Protocols documentation; Publications; Quality of life; Randomized; Recruitment Activity; Residual volume; Sabal serrulata; Safety; Schedule; Sleep; Specific qualifier value; Symptoms; Time; United States National Institutes of Health; Universities; arm; base; dietary supplements; follow-up; indexing; meetings; public health relevance; treatment duration; urologic

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.

描述（由申请人提供）：本提案是12个提案之一，11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，该临床试验正在研究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项提案中的每一项都包括一个在研究指导委员会职权范围内编写的共同部分，然后是一个针对提交申请的中心的部分。此特定申请适用于加拿大安大略金斯顿的女王大学临床中心。该中心的详细信息开始于下面公共部分后面的第页。整个CAMUS试验（泌尿系统症状的补充和替代医学）功能齐全，正在进行中。由NIDDK、国家补充和替代医学中心（NCCAM）和膳食补充剂办公室（ODS）联合资助，它成功地随机分配了369名参与者，超过了最初目标的350人;但是，在此情况下，招募时间长于最初预期的6个月，因此方案规定的最后一批招募参与者的治疗期现在超过了当前的资助期，2010年3月31日。第一名参与者计划于2009年12月完成随访，最后一名参与者计划于2010年10月完成随访。因此，需要额外的资金，以允许所有CAMUS受试者完成方案中规定的72周随访，并允许进行适当的数据清理、分析和发表。CAMUS是一项随机、双盲、两组试验，共有369名参与者，在连续三个24周的时间内以递增剂量大致均等地分配到Serenoa repens提取物或安慰剂组，从每天320 mg开始，然后是640 mg，然后是960 mg。受试者继续接受研究治疗，直至符合方案规定的治疗中止原因或完成72周治疗期。11家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例受试者的随机化。 公共卫生相关性：未给出声明。