ITMCTR2000003082尚未招募1 期
A clinical study for the therapeutic effect of acupuncture and moxa combustion on prostate hyperplasia
Shanghai 4th People's Hospital affiliated to Tongji University0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 45 至 80(—)
- 性别
- Male
入选标准
- •1. Healthy males aged 45 years old or older;
- •2. Subjects with benign prostatic hyperplasia diagnosed by digital rectal examination;
- •3. Volume of the prostate equals to or over 30 ml;
- •4. Maximum urinary flow rate <15 ml/s;
- •5. Subjects with lower urinary tract symptoms suggestive of benign prostate hyperplasia, who voluntarily agree to join and sign to the consent form;
- •6. Have been treated with conventional first-line western medicine for more than three months;
- •7. Patients with moderate to severe benign prostatic hyperplasia (IPSS score 8-19 points).
排除标准
- •1. Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 5 years;
- •2. Subjects who have acute urinary retention within 4 weeks before screening;
- •3. Subjects who have clinically significant severe cardiovascular disease (unstable angina, myocardial infarction or arrhythmia) within 6 months before screening;
- •4. Subjects who have concerns about acupuncture;
- •5. Subjects who were suspected or confirmed calculus of lower urinary tract, calculus of bladder (except for complete recovery);
- •6. Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial;
- •7. Concurrent use of other Chinese herbal medicines or alternative medicine (including drugs and acupuncture) for more than one month;
- •8. Syphilis, gonorrhea and other sexually transmitted diseases or urinary tract infections;
- •9. Congenital abnormalities such as bladder neck fibrosis, interstitial cystitis or urethral stricture;
- •10. A history of genital trauma or surgery affecting the muscle or nervous system;
- •11. Patients with upper urinary tract obstruction, renal edema, etc. affecting renal function;
- •12. Unable to sign a consent form or unable to communicate with researchers.
研究者
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