Guiyi Tonglong Formula for moderate benign prostatic hyperplasia patients with kidney deficiency and blood stasis syndrome: a protocol for a multicenter, double-blind, double-dummy, randomized controlled
trial

Background: Benign prostatic hyperplasia (BPH) is common in middle-aged and older men and frequently causes lower urinary tract symptoms that impair quality of life. Guiyi Tonglong Formula, a standardized traditional Chinese medicine prescription derived from Guizhi Fuling Wan, has shown preliminary efficacy and safety in patients with BPH characterized by kidney deficiency with blood stasis, but robust multicenter evidence is lacking. Methods: This multicenter, double-blind, double-dummy, randomized, parallel-controlled superiority clinical trial will recruit 138 men aged 50–75 years with moderate BPH and kidney deficiency with blood stasis syndrome from five centers in China. Participants will be randomized 1:1 to receive Guiyi Tonglong Formula Granules plus a placebo matching tamsulosin hydrochloride extended-release capsules or tamsulosin hydrochloride extended-release capsules plus a placebo matching Guiyi Tonglong Formula Granules. Treatment will last 12 weeks, followed by a 4-week follow-up. The primary endpoint is the change in International Prostate Symptom Score (IPSS) from baseline to Week 12. Secondary endpoints include quality of life scores, maximum urinary flow rate, post-void residual urine volume, prostate volume, Traditional Chinese medicine (TCM) symptom scores, and IPSS subscale scores. Safety will be assessed through physical examinations, vital signs, laboratory tests, electrocardiograms, and adverse-event monitoring. The primary analysis will use a mixed-effects model for repeated measures in the full analysis set. Results: The trial is ongoing, and no outcome data are available at this stage. Conclusions: This study aims to systematically evaluate the efficacy and safety of Guiyi Tonglong Formula in treating moderate BPH (kidney deficiency with blood stasis syndrome). The results are expected to provide a new reference for TCM treatment options in the management of BPH. Clinical Trial Registration: ITMCTR2025001403.

Guiyi Tonglong Formula; Benign prostatic hyperplasia; Traditional Chinese medicine

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