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临床试验/ITMCTR2000003082
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

发起方
Shanghai 4th People's Hospital affiliated to Tongji University

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