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A Randomized, Double-Blind, Placebo-controlled, multicentre Clinical Study to Evaluate the Efficacy and Safety of Danyi Tablet in the treatment of Chronic Prostatitis(pattern of static blood obstructing and dampness-heat pouring down)

A Randomized, Double-Blind, Placebo-controlled, multicentre Clinical Study to Evaluate the Efficacy and Safety of Danyi Tablet in the treatment of Chronic Prostatitis(pattern of static blood obstructing and dampness-heat pouring down)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002958
Enrollment
Unknown
Registered
2012-12-31
Start date
2007-11-09
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic prostatitis

Interventions

experimental group:Dan Yi Tablet
Control group:Placebo

Sponsors

Second affiliated Hospital of Tianjin University of TCM
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. in line with western medicine of chronic prostatitis diagnosis standard; 2. with TCM Syndromes of blood stasis of damp-heat in diagnostic criteria; 3. age 18-50 years old, male; 4. more than 3 months duration; 5. trials within 2 weeks before receiving the same medication or other treatment; 6. signed informed consent.

Exclusion criteria

Exclusion criteria: 1. acute prostatitis; 2. benign prostatic hyperplasia, prostate cancer, neurogenic bladder, urethritis, urethral malformation or stenosis and severe neurosis; 3. to local pain as the main manifestations of the patients, attention should be paid to exclude the lower abdomen, perineum, lumbosacral and other parts of the other lesions, such as ureteral calculus, vesical calculus, inguinal hernia, osteitis pubis, varicocele, epididymitis, rectosigmoid colon diseases, such as lumbar back myofascitis; 4. combine heart, brain, liver and kidney and hematopoietic system of severe primary diseases; 5. allergic or to test drug ingredients known allergy; 6. active ulceration and bleeding tendency; 7. cannot be partners, such as psychiatric patients.

Design outcomes

Primary

MeasureTime frame
NIH-CPSI score (total score, pain score, QOL score);TCM syptom total score;

Secondary

MeasureTime frame
EPS examination;prostate digital examination;Prostatic fluid bacterial culture;The single symptom scores;

Countries

China

Contacts

Public ContactWei Rui
weiwei1963@sina.com+86 15823971158

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026