A multicenter, randomized, double-blind, placebo-controlled trial for Xialiqi in the treatment of BPH

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900022393

Enrollment

Unknown

Registered

2019-04-09

Start date

2019-05-01

Completion date

Unknown

Last updated

2019-04-15

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

Conditions

benign prostatic hyperplasia

Interventions

placebo-controlled:Basic treatment + Xialiqi capsules placebo

Experimental group:Basic treatment + Xialiqi capsules

Eligibility

Sex/Gender

Male

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnosis of benign prostatic hyperplasia (BPH); 2. International prostate symptom score (IPSS) between 8 points and 19 points; 3. Prostate volume (PV) = 30ml; 4. Maximum urinary flow rate <15ml/s; 5. Aged between 50 and 80 years old (including 50 and 80 years old); 6. Voluntary participation in the study with a signed consent form.

Exclusion criteria

Exclusion criteria: 1. Residual urine volume >150ml; 2. Serum PSA>4 ng/mL; 3. Serious hepatorenal dysfunction [ATL=5 ULN , Cr>134µmol/L (2mg%) or eGFR<45ml/min/1.73m2]; 4. Serious chronic obstructive pulmonary disease (COPD) or respiratory failure; 5. Severe infection; 6. Very weak or frailty; 7. Neuropsychiatric system diseases; 8. Malignancies; 9. Allergy to the ingredients of this investigational drug; 10. Participation in clinical study of other traditional Chinese medicine (TCM); 11. The investigator judges any disease other than benign prostatic hyperplasia that can cause changes in urinary symptoms or changes in urinary flow rate (eg, neurogenic bladder, bladder neck fibrosis, neobladder bladder, bladder tumor, urinary calculi, urethral stricture, phimosis or penis,Tumor, acute or chronic prostatitis, prostate cancer, acute and chronic urinary tract infection, acute and chronic renal failure, etc.); 12. The investigator determined that other patients who are not suitable for this study.

Design outcomes

Primary

Measure	Time frame
IPSS;International prostate symptom score;	—

Countries

China

Contacts

Public ContactNianzeng Xing

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

nianzeng2006@vip.sina.com+86 18601238866

Outcome results

None listed

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