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RecruitingEarly Phase 1NCT06689514

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

Sponsor

Yifeng Jing

Enrollment

30 participants

Start Date

Jan 20, 2025

Study Type

INTERVENTIONAL

Conditions

Prostatic Hypertrophy, Benign

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.

Eligibility

Sex: MALEMin Age: 55 YearsMax Age: 75 Years

Inclusion Criteria3

  • Patients with benign prostatic hyperplasia aged 55 to 75 years old;
  • The patient's prostate volume is greater than 40mL;
  • There is urinary obstruction, with an International Prostate Symptom Score (IPSS) greater than or equal to 8 points, and a maximum urinary flow rate of less than 15ml/s (urinary flow rate is not measured in patients with indwelling catheters).

Exclusion Criteria11

  • Urinary disorders caused by neurogenic diseases;
  • Acute urinary tract infections have not been effectively controlled;
  • There are factors of lower urinary tract obstruction other than BPH, such as urethral stricture;
  • History of radiation therapy or surgery in the lower urinary tract or pelvic cavity;
  • Have ever suffered from tumor of urinary system, or suspected of suffering from tumor of urinary system (such as bladder cancer cancer, prostate cancer);
  • Current or past liver function abnormalities (exceeding the test reference value limit);
  • Abnormal renal function (exceeding the test reference value limit);
  • Currently taking warfarin;
  • Allergic to tranilast or drug preparations;
  • Suffering from other major diseases (malignant tumors, autoimmune diseases, angina pectoris, heart failure, severe respiratory and digestive diseases, etc.), and not yet clinically cured;
  • Other researchers believe that patients who are not suitable to participate in this trial.

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Interventions

DRUGalpha receptor antagonist

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

DRUGLow dose Tranilast

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

DRUGHigh dose Tranilast

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

Locations(2)

Shanghai General Hospital

Shanghai, Outside U.S./Canada, China

Shanghai General Hospital

Shanghai, China

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NCT06689514