Skip to main content
Clinical Trials/ITMCTR2000003082
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional study
Sex
Male

Investigators

Sponsor
Shanghai 4th People's Hospital affiliated to Tongji University

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

Similar Trials