ITMCTR2000003082
Not yet recruiting
Phase 1
A clinical study for the therapeutic effect of acupuncture and moxa combustion on prostate hyperplasia
Shanghai 4th People's Hospital affiliated to Tongji University0 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shanghai 4th People's Hospital affiliated to Tongji University
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Not specified
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