NCT05732441进行中（未招募）不适用
A Randomized Controlled Clinical Trial of a Plant Drug (HuangE Capsule) in the Treatment of Patients With Elevated Psa Prostatitis
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum PSA
研究概览
简要总结
This clinical study was mainly aimed at exploring the efficacy of herbal medicine (Huange Capsule) in the treatment of patients with prostatitis with elevated PSA.
The main questions it aims to answer are:
- To evaluate the influence and exact curative effect of huange capsule on serum PSA level of patients with PSA-elevated prostatitis, to improve the specificity of PSA and reduce unnecessary puncture biopsy.
- To provide evidence-based evidence for clinical efficacy evaluation Subjects will be randomized to a routine regimen with or without the use of Huangge capsules. To evaluate whether the efficacy of the conventional treatment combined with Huange capsule group was superior to that of the conventional medication group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Compliant with the diagnostic criteria of both Chinese and western medicine for prostatitis;
- •Serum PSA increases, ranging from 4 ng/mL to 10 ng/mL;
- •Male, aged between 18 and 80 years old:
- •B-ultrasound and imaging examination fail to consider the front row cancer;
- •I have not taken any Chinese or western medicine for the treatment of prostatitis in the past two weeks;
- •Those who have signed the informed consent form.
排除标准
- •Patients with frequent micturition caused by combined sexually transmitted diseases and urinary tract infection;
- •oliguria or anuria caused by urinary calculi, prostate cancer, and acute and chronic renal failure;
- •Dysuria caused by neurogenic bladder collapse, bladder neck collapse fibrosis, and urethral stricture;
- •the residual urine volume > 150ml:
- •Losers of invasive treatment of benign prostatic obstruction;
- •Patients with pelvic surgery or injury history that affected the local internal organs, muscles, nerves and other functional states;
- •B-ultrasound shows obvious bladder diverticulum or upper urinary tract obstruction caused by BPH, with impaired renal function;
- •Patients with severe primary diseases such as cardiovascular and cerebrovascular diseases, liver and hematopoietic system, refractory diabetes mellitus, or diabetic neuropathy and psychosis;
- •Patients with serum t-PSA>10ng/ml.
研究组 & 干预措施
Conventional treatment group combined with Huange capsule
Experimental
Based on the clinical guidelines, the routine treatment was used in addition to Huange Capsule.
干预措施: Huange capsule (Drug)
结局指标
主要结局
Serum PSA
时间窗: 4 weeks
International prostate symptom score
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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