Benign prostatic hyperplasia
Conditions
Interventions
Treatment group:Conventional treatment combined with Xialiqi Capsules
Control group:Conventional treatment
Sponsors
Shijiazhuang Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Male
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meets the Western medicine diagnosis of benign prostatic hyperplasia (BPH) and fits the Traditional Chinese Medicine pattern of spleen and kidney qi deficiency with phlegm and blood stasis; (2) International Prostate Symptom Score (IPSS) total score =8 and =19; (3) Prostate volume (PV) =30ml (by ultrasound examination); (4) Age between 50 and 80 years old (including 50 and 80); (5) Voluntarily participates in the clinical trial and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Residual urine volume >150 ml; (2) Severe liver and kidney dysfunction [ALT =5 ULN, Cr >177 µmol/L (2 mg/dl) or eGFR <45 ml/min/1.73m²]; (3) Self-reported severe primary diseases involving liver, kidney, hematopoietic system, malignant tumors, or psychiatric disorders; (4) Allergy to the components of the study drug; (5) Participation in other clinical studies within 1 month prior to enrollment; (6) Factors judged by the investigator to be otherwise unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in IPSS score at 12 weeks (comparing the change in the average International Prostate Symptom Score (IPSS) from baseline between the two groups at 12 weeks); | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the changes in 12-week NIH-CPSI scores from baseline between the two groups;Compare the changes in prostate volume between the two groups 12 weeks before (measured by ultrasound, using the formula V = p/6 × anteroposterior diameter × transverse diameter × vertical diameter) relative to the baseline period.;Compare the changes from baseline in residual urine volume (RU, measured by ultrasound, formula RU = 0.75 × anteroposterior diameter × transverse diameter × vertical diameter) at 12 weeks between the two groups;Compare the changes in 12-week QOL (quality of life) scores between the two groups relative to baseline; | — |
Countries
China
Contacts
Public ContactYongcun Liu
Shijiazhuang Hospital of Traditional Chinese Medicine
Outcome results
None listed