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Clinical Study on Guilong Dan Fang in the Treatment of Type III Chronic Prostatitis (Dampness Heat And Blood Stasis Type)

Clinical Study on Guilong Dan Fang in the Treatment of Type III Chronic Prostatitis (Dampness Heat And Blood Stasis Type)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083575
Enrollment
Unknown
Registered
2024-04-28
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Chronic prostatitis

Interventions

Group 1:Guilong Dan Granules
Group 2:Qianlie Shutong Capsules

Sponsors

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1) Those who meet the NIH-CPSI criteria for Western medicine diagnosis; (NIH-CPSI = 15 points); (2) Those who meet the standards of traditional Chinese medicine for chronic prostatitis with damp heat and stasis obstruction; (3) Between the ages of 18 and 50; (4) The course of the disease is = 3 months; (5) Patients who have already undergone treatment before seeking medical attention can only be included after stopping medication for at least 2 weeks; (6) Voluntarily participate in treatment and sign an informed consent form for the trial.

Exclusion criteria

Exclusion criteria: (1) Combine benign prostate obstruction, prostate cancer, neurogenic bladder, urethral deformity or stenosis, urinary calculi, urinary tract infection, severe neurosis and other diseases affecting urination; (2) Diseases that cause pain in the perineal region due to the combination of prostate abscess, inguinal hernia, pubic inflammation, varicocele, epididymitis, and rectal colon disease; (3) Ever received prostate surgery or laser, radiofrequency, microwave, ablation therapy; (4) Primary diseases such as cardiovascular disease, hematopoietic system disease, liver and kidney dysfunction; (5) Serious diabetes, mental illness and other serious diseases; (6) Allergic constitution or allergy to multiple drugs; (7) Patients with anxiety, depression (Self-Rating Anxiety Scale and Depression Scale) or neurological disorders who cannot express their will, have difficulty moving, or cannot cooperate with treatment and examination; (8) Those who have serious tobacco and alcohol addictions (unable to control their smoking and drinking habits, and experiencing hand tremors, palpitations, and anxiety when not smoking or drinking) and drug addiction that affect their daily lives; (9) Patients who participated in other clinical trials within one month; (10) Patients taking drugs that affect the metabolism of this drug.

Design outcomes

Primary

MeasureTime frame
NIH chronic prostatitis symptom index,NIH-CPSI;

Secondary

MeasureTime frame
NIH-CPSI three sub scores, including pain or discomfort score, urinary symptom score, and quality of life score);Quantitative grading of traditional Chinese medicine symptoms;Prostate specialist examination score;SAS-SDS;

Countries

China

Contacts

Public ContactHuang Yuhong

Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

hyh101@126.com+86 22 6063 7918

Outcome results

None listed

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