Complementary and Alternative Medicine for Urological Symptoms(CAMUS)
Anahtar kelimeler
Öz
Açıklama
The CAMUS trial is studying the outcomes using herbal therapy for benign prostatic hyperplasia (BPH).
BPH is a common problem for older men. With BPH, the prostate grows larger. Over time, this growth can cause bothersome urinary symptoms. These symptoms can include frequent and/or urgent urination during the day or at night. Men with BPH can also have a weak urine stream, a stream that stops and starts, a feeling of not emptying the bladder all the way, and/or a need to strain to get urination started. BPH is NOT the same as prostate cancer.
A number of natural products (extracts of different plants) seem to be able to reduce the bothersome symptoms of BPH with very few side effects over a few months. One of the plant extracts comes from the dwarf palm tree (Saw palmetto). The investigators do not know whether these plant extracts will reduce the symptoms of BPH over a longer period of treatment.
Tarih
Son Doğrulandı: | 08/31/2012 |
İlk Gönderilen: | 12/19/2007 |
Tahmini Kayıt Gönderildi: | 01/27/2008 |
İlk Gönderilen: | 01/28/2008 |
Son Güncelleme Gönderildi: | 09/11/2012 |
Son Güncelleme Gönderildi: | 10/11/2012 |
İlk gönderilen sonuçların tarihi: | 04/25/2012 |
QC sonuçlarının ilk gönderildiği tarih: | 09/11/2012 |
İlk yayınlanan sonuçların tarihi: | 10/11/2012 |
Fiili Çalışma Başlangıç Tarihi: | 01/31/2008 |
Tahmini Birincil Tamamlanma Tarihi: | 11/30/2010 |
Tahmini Çalışma Tamamlanma Tarihi: | 11/30/2010 |
Durum veya hastalık
Müdahale / tedavi
Drug: Saw Palmetto
Drug: Placebo
Drug: Saw Palmetto
Drug: Placebo
Drug: Saw Palmetto
Drug: Placebo
Evre
Kol Grupları
Kol | Müdahale / tedavi |
---|---|
Placebo Comparator: Placebo Participants will take one 320 mg placebo gelcap daily for 24 weeks one gelcap); followed by 640 mg daily for 24 weeks (two gelcaps) followed by 960 mg daily for 24 weeks (three gelcaps). | Drug: Placebo Participants will take one 320 mg chocolate-colored soft gelcaps containing a placebo for 24 weeks. |
Active Comparator: Saw Palmetto Extract of Serenoa Repens 320 mg once daily for 24 weeks (one gelcap); followed by 640 mg daily for 24 weeks (two gelcaps) followed by 960 mg daily for 24 weeks (three gelcaps). | Drug: Saw Palmetto Participants will take one 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks. |
Uygunluk kriterleri
Çalışmaya Uygun Yaşlar | 45 Years İçin 45 Years |
Çalışmaya Uygun Cinsiyetler | Male |
Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
Kriterler | Inclusion Criteria: To be eligible for the study, potential participants must meet all of the following eligibility criteria: 1. Male at least 45 years of age. 2. Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml. 3. AUA symptom score ≥ 8 and ≤ 24 at both screening visits. 4. Voluntarily signed informed consent agreement prior to the performance of any study procedures. Exclusion Criteria: Potential participants that meet any of the following exclusion criteria will be excluded from the full-scale trial: 1. Any prior invasive intervention for BPH. 2. Phytotherapy for BPH or a 5-alpha reductase inhibitor within 3 months. 3. Alpha blocker within one month. 4. Reported allergic reaction to Serenoa repens. 5. Taken phenylephrine, pseudoephedrine, tricyclic antidepressants, and anticholinergic or cholinergic medication within 4 weeks of the first screening visit, with the following exception: topical anticholinergic eye drops used for glaucoma. 6. Taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids within 6 months. 7. Known clinically significant renal impairment (i.e., creatinine greater than 2.0 mg/dl). 8. Alanine aminotransferase(ALT)serum glutamic pyruvic transaminase(SGPT), aspartate aminotransferase(AST)serum glutamic oxaloacetic transaminase (SGOT) or gamma-glutamyltranspeptidase (GGT) value greater than 3 times the upper limit of normal in the clinical center lab at SV1.0; confirmed on a second measurement. 9. Prothrombin time greater than 3 seconds above the upper limit of normal, or more than 3 seconds above the control value in the clinical center at SV1.0; confirmed on a second measurement. 10. Electrocardiogram (ECG) reading at the clinical center at SV1.0 suggesting active ischemia or recent myocardial infarction until appropriate consultation confirms the absence of an acute coronary syndrome. 11. Prostate-specific antigen (PSA) level greater than 10 ng/ml at the first screening visit. 12. Requires the daily use of a pad or device for incontinence, or International Continence Society male incontinence symptom (ICSmaleIS) score >14 at screening. 13. Unstable medical condition within the past 3 months. 14. History or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, urethral stricture, or prior surgery for bladder neck obstruction. 15. Active urinary tract disease or has undergone cystoscopy or biopsy of the prostate within one month prior to the first screening visit or has an imminent need for urologic surgery. 16. Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function. 17. Documented bacterial prostatitis within the past year. 18. Two documented independent urinary tract infections of any type in the past year. 19. Known severe bleeding disorder or need for ongoing therapeutic anticoagulation with coumadin or heparin. 20. Cancer, which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of randomization. A history of bladder cancer or prostate cancer is exclusionary whether the participant is considered cured or not. 21. Unable to follow protocol directions due to organic brain or psychiatric disease. 22. History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol. 23. Any serious medical condition likely to impede successful completion of the study. |
Sonuç
Birincil Sonuç Ölçütleri
1. Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants. [Baseline to 72 weeks]
İkincil Sonuç Ölçütleri
1. Participants Global Assessments of Improvement and Satisfaction at End of Study. [Baseline to 72 weeks]
2. Benign Prostate Hyperplasia (BPH) Impact Index Score [Baseline to 72 weeks]
3. International Prostate Symptom Score Quality of Life (IPSS QOL) Score [Baseline to 72 weeks]
4. American Urological Association(AUA) Nocturia Item [Baseline to 72 weeks]
5. Peak Uroflow [Baseline to 72 weeks]
6. Post-void Residual [Baseline to 72 weeks]
7. Prostate Specific Antigen (PSA) Level [Baseline to 72 weeks]
8. International Index of Erectile Function (IIEF)Scale Score. [Baseline to 72 weeks]
9. Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score. [Baseline to 72 weeks.]
10. International Continence Society Male Incontinence Symptom (ICSmale IS) Score [Baseline to 72 weeks]
11. Jenkins Sleep Scale Score [Baseline to 72 weeks]
12. NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale [Baseline to 72 weeks]
13. NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale [Baseline to 72 weeks]
14. NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale [Baseline to 72 weeks]