An open-labelled, prospective clinical study to evaluate effect of Prostate24 in benign prostatic hyperplasia male human patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Mean percent changes in the overall signs and symptoms of BPH after the treatment with Prostate24 from baseline to 60 days. These will include,
研究概览
简要总结
| PROTOCOL NUMBER |
IPNU/002/22
|PROTOCOL TITLE
An Open-Labelled, Prospective Clinical Study to Evaluate Effect of Prostate24 In Benign Prostatic Hyperplasia Male Human Patients.
|AIM
The aim of the proposed study is to evaluate effect of Prostate24, a nutraceutical formulation on BPH patients.
|OBJECTIVES
Primary Objective: To evaluate mean changes in the overall signs and symptoms of BPH after the treatment with Prostate24 from baseline to 60 days.
Secondary Objective: To assess the safety of Prostate24 based upon basic vital signs.
|NUMBER OF PATIENTS
15
|STUDY MEDICATION
Prostate24; each contains curcuminoids and zinc complex (150mg) and proprietary blend of Pygeum africanum, Say palmetto and Nelumbo nucifera (250mg).
|DOSE AND METHOD OF ADMINISTRATION
Prostate24 [400mg] Capsule twice a day orally.
|STUDY DURATION
Total expected duration of study will be for 60 days.
|TOTAL BLOOD LOSS
Total blood loss in this study will not be more than 30 ml.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •i.Age above 45 years ii.Male participants diagnosed with BPH iii.Participant must not have taken any drug/ vitamin/ mineral/ dietary or herbal supplements for BPH 1 month prior to enrolment in the study and agrees to not use any new vitamins and/or minerals and/or dietary and/or herbal supplements until after study completion.
- •iv.Participant must be able, willing and likely to fully comply with study procedures and restrictions.
- •v.Participant willing to sign the informed consent.
排除标准
- •i.Evidence of renal disease (S.
- •Creatinine > 1.5mg/ml) ii.Evidence of liver disease (AST/ALT >3 times of normal) iii.History of alcohol intake and smoking.
- •iv.Participation in any other clinical trial with in the last 30 days v.History of intake of diuretics, Finasteride like drugs or dietary supplements for the treatment of BPH vi.History of intolerance or hypersensitivity to any of the content of the study drug vii.Any condition which in the opinion of the PI that is significant and can make the subject unsuitable for study or can place it under additional risk, such as intolerance, allergy to study drug, etc.
结局指标
主要结局
Mean percent changes in the overall signs and symptoms of BPH after the treatment with Prostate24 from baseline to 60 days. These will include,
时间窗: 0, 30, 60 day
•Physical examination and DRE
时间窗: 0, 30, 60 day
• PSA
时间窗: 0, 30, 60 day
•CRP
时间窗: 0, 30, 60 day
•Sr. Creatinine
时间窗: 0, 30, 60 day
次要结局
- To assess the adverse drug reactions of Prostate24(0, 30, 60 day)