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Study on the Effectiveness of Tranilast in the Treatment of Medium to Large Volume Benign Prostatic Hyperplasia

NCT06689514 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-08

No results posted yet for this study

Summary

Benign prostatic hyperplasia (BPH) is one of the most common urinary and reproductive system diseases in elderly men. The preliminary research of the research group found that mast cells are cells that promote the progression of BPH, and the commonly used mast cell membrane stabilizer and TGF - β pathway inhibitor tranilast significantly inhibited the increase in prostate volume in animal experiments, which is considered to have potential applications in the treatment of BPH. This study plans to include 30 patients with medium to large volume BPH and experimentally explore the efficacy and safety of tranilast in the treatment of medium to large volume BPH.

Conditions

  • Prostatic Hypertrophy, Benign

Interventions

DRUG

alpha receptor antagonist

Oral administration of alpha receptor antagonist (according to the dosage specified in the instructions for treating BPH)

DRUG

Low dose Tranilast

Oral administration of Tranilast Capsules (Qu Ke Shen, Yao Da Pharmaceutical) 100mg TID

DRUG

High dose Tranilast

Oral administration of Tranilast Capsules (Qu Ke Shen, Yao Da Pharmaceutical) 200mg TID

Sponsors & Collaborators

  • Yifeng Jing

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06689514 on ClinicalTrials.gov