Actively Recruiting

Early Phase 1
Age: 55Years - 75Years
MALE
NCT06689514

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

Led by Yifeng Jing · Updated on 2026-01-08

30

Participants Needed

2

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 55Years - 75Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with benign prostatic hyperplasia aged 55 to 75 years old
  • Prostate volume greater than 40 mL
  • Urinary obstruction with an International Prostate Symptom Score (IPSS) of 8 or higher
  • Maximum urinary flow rate less than 15 mL/s (not measured if catheterized)
Not Eligible

You will not qualify if you...

  • Urinary disorders caused by neurogenic diseases
  • Uncontrolled acute urinary tract infections
  • Lower urinary tract obstruction from causes other than BPH, such as urethral stricture
  • History of radiation therapy or surgery in the lower urinary tract or pelvic area
  • History or suspicion of urinary system tumors (e.g., bladder or prostate cancer)
  • Current or past abnormal liver function exceeding normal limits
  • Abnormal kidney function exceeding normal limits
  • Current use of warfarin
  • Allergy to tranilast or related drugs
  • Presence of major untreated diseases like malignant tumors, autoimmune diseases, angina, heart failure, or severe respiratory or digestive illnesses
  • Any other conditions deemed unsuitable by the researchers

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Shanghai General Hospital

Shanghai, Outside U.S./Canada, China, 200086

Actively Recruiting

2

Shanghai General Hospital

Shanghai, China, 200086

Not Yet Recruiting

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Research Team

Y

Yifeng Jing

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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