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Single-arm, open, multi-center phase IV clinical trial of Lingze tablet in the treatment of benign prostatic hyperplasia

Single-arm, open, multi-center phase IV clinical trial of Lingze tablet in the treatment of benign prostatic hyperplasia

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2000003335
Enrollment
Unknown
Registered
2020-05-23
Start date
2017-01-14
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Prostatic hyperplasia

Interventions

Sponsors

The First Affiliated Hospital of Tianjin University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of BPH; 2. Conform to the syndrome differentiation standard of kidney deficiency, blood stasis and dampness syndrome (not required by Western Hospital); 3. Men aged 50-80 years; 4. Sign the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Residual urine volume > 150ml; 2. There are other diseases that cause dysuria, such as neurogenic bladder dysfunction, vesicourethral calculus, bladder neck obstruction, urethral stricture, recurrent urinary infection, urinary incontinence, pelvic radiotherapy, postoperative pelvic surgery, bacterial prostatitis, and patients or blood PSA >4 whose prostate biopsy shows any grade of prostatic intraepithelial tumor (PIN) Ng / ml patients with suspected prostate cancer; 3. Received soft / hard cystoscopy or other urethral instrument operators within 7 days before the study; 4. Patients with gastroduodenal ulcer, acute and chronic gastritis and enteritis; 5. Those who have recently complicated with serious cardiovascular and cerebrovascular diseases, serious liver and kidney damage, severe hypertension, poor control of diabetes, blood system diseases, mental disorders, and a history of alcohol dependence or drug abuse; 6. Those who are allergic to the ingredients in the study drug; 7. According to the judgment of the researcher, it is not suitable to join the clinical trial.

Design outcomes

Primary

MeasureTime frame
International Prostate Symptom (I-PSS) score;Curative effect of TCM Syndrome;

Secondary

MeasureTime frame
Quality of life index (QOL) score;Residual urine volume of bladder (PVR);Prostate volume;Efficacy of single symptom;

Countries

China

Contacts

Public ContactJinhua He
hjh5088@sina.com+86 13821820876

Outcome results

None listed

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