Alternative Therapies for Benign Prostatic Symptoms

良性前列腺症状的替代疗法

• 批准号: 7989762
• 负责人: MICHAEL J NASLUND
• 金额: $ 7.82万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7989762
• 关键词: Alternative Therapies; Appointment; Benign; Berry; Blood Chemical Analysis; Chronic Prostatitis; Clinical; Clinical Trials; Complete Blood Count; Data; Data Coordinating Center; Data Set; Functional disorder; Funding; Hyperplasia; Incontinence; Measures; Nocturia; Paper; Patients; Persons; Pharmaceutical Preparations; Placebos; Plants; Principal Investigator; Prostate-Specific Antigen; Prostatic; Protocols documentation; Publications; Quality of life; Research; Residual volume; Sabal serrulata; Safety; Sleep; Specific qualifier value; Symptoms; Time; United States National Institutes of Health; Visit; Work; base; follow-up; indexing; meetings; public health relevance; symposium

DESCRIPTION (provided by applicant): During this period the study protocol will be active and patients will be completeting their final study visits. Dr. Michael Naslund, PI and Research Coordinator will be seeing the patients for their study visits as well as keeping all regulatory documents in the study current. Additionally the RC will see that all needed lab work and EKGs for patients are conducted at each visit and that patients are adhering to study protocol and are continuing to be compliant to their study medication. The PI and RC will also be making sure that patient retention remains high. We will contact all patients between visits and continue to remind them of any upcoming appointments they have with our office. Dr. Naslund who serves on the CAMUS recruitment and retention board as well as the Steering committee will continue his duties by participating in numerous conference calls and any Steering Committee in person meetings. The RC will also attend coordinator conference calls and study meetings. After the final patient completes his last in office (end of study) visit, we will work with the Data Coordinating Center to complete as well as edit all necessary data to close out the study. PUBLIC HEALTH RELEVANCE: 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 NlDDK's CAMUS clinical trial that is investigating the efficacy and safety of an extract of the berries of Serenoa repens (the saw palmetto plant) for the treatment of benign prostrate hyperplasia (BPH).

描述（由申请人提供）：在此期间，研究方案将是活跃的，患者将完成他们的最终学习访问。 PI和研究协调员Michael Naslund博士将与患者进行学习访问，并将所有监管文件保留在研究中。此外，RC将看到每次访问时进行所有需要的实验室工作和患者的心电图，并且患者正在遵守研究方案，并继续遵守他们的研究药物。 PI和RC还将确保患者保留率保持较高。我们将在访问之间与所有患者联系，并继续提醒他们他们在我们办公室的任何即将到来的约会。在CAMUS招聘和保留委员会以及指导委员会任职的Naslund博士将通过参加许多电话会议和任何指导委员会，继续他的职责。 RC还将参加协调电话会议和学习会议。最终患者完成了他的最后一次办公室（研究结束）访问后，我们将与数据协调中心合作完成并编辑所有必要的数据以结束研究。 公共卫生相关性：该提案是12个临床中心中的每个提案之一，以及一个用于数据协调中心（DCC）的提案，与NLDDK的CAMUS临床试验的持续资助有关，该试验正在研究提取物的功效和安全性Serenoa Repens（Saw Palmetto植物）的浆果用于治疗良性pro亵增生（BPH）。

项目成果

Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia.

招募参与者参加植物疗法治疗良性前列腺增生的临床试验。

• DOI: 10.1089/acm.2010.0300
• 发表时间: 2011
• 期刊: Journal of alternative and complementary medicine (New York, N.Y.)
• 作者: Lee,JeannetteY;FosterJr,HarrisE;McVary,KevinT;Meleth,Sreelatha;Stavris,Karen;Downey,Joe;Kusek,JohnW
• 通讯作者: Kusek,JohnW

Relationships among participant international prostate symptom score, benign prostatic hyperplasia impact index changes and global ratings of change in a trial of phytotherapy in men with lower urinary tract symptoms.

• DOI: 10.1016/j.juro.2012.08.257
• 发表时间: 2013-03
• 期刊: JOURNAL OF UROLOGY
• 影响因子: 6.6
• 作者: Barry, Michael J.;Cantor, Alan;Roehrborn, Claus G.
• 通讯作者: Roehrborn, Claus G.

The effect of increasing doses of saw palmetto fruit extract on serum prostate specific antigen: analysis of the CAMUS randomized trial.

• DOI: 10.1016/j.juro.2012.09.037
• 发表时间: 2013-02
• 期刊: JOURNAL OF UROLOGY
• 影响因子: 6.6
• 作者: Andriole, Gerald L.;McCullum-Hill, Christie;Sandhu, Gurdarshan S.;Crawford, E. David;Barry, Michael J.;Cantor, Alan
• 通讯作者: Cantor, Alan

Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto.

研究参与者在锯棕榈双盲剂量递增临床试验中对治疗分配的猜测。

• DOI: 10.1089/acm.2012.0284
• 发表时间: 2014
• 期刊: Journal of alternative and complementary medicine (New York, N.Y.)
• 作者: Lee,JeannetteY;Moore,Page;Kusek,John;Barry,Michael;CAMUSStudyGroup
• 通讯作者: CAMUSStudyGroup