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A Randomized, Double-Blind, Positive-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, Positive-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 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002957
Enrollment
Unknown
Registered
2012-12-31
Start date
2008-05-29
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

control group:Qianlietai granule
experimental group:Danyi Tablet

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. meet the diagnostic criteria of Chronic Prostatitis; 2. meet the diagnostic criteria of pattern of static blood obstructing and dampness-heat pouring down; 3. age 18-50 years old, male; 4. The course of the disease>=3 months; 5. not receive the similar drug therapy or other treatment in the last two weeks; 6. Signed the informed consent form prior to the study participation.

Exclusion criteria

Exclusion criteria: 1. benign prostatic hyperplasia, prostate cancer, neurogenic bladder, urethritis, urethral malformation or stenosis and severe neurosis; 2. 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; 3. combine heart, brain, liver and kidney and hematopoietic system of severe primary diseases; 4. allergic or to test drug ingredients known allergy; 5. active ulceration and bleeding tendency; 6. cannot be partners, such as psychiatric patients.

Design outcomes

Primary

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

Secondary

MeasureTime frame
the general therapeutic effect of Chinese medicine;Chinese medicine syndrome score;the single-item score of Chinese medicine syndrom;EPS examination;prostate digital examination;

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