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

NCT06689514 | Recruiting Early Phase 1 DMC

• 2 other identifiers: 2024HS19782270810
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Prostatic Hypertrophy

Outcome Measures

Primary Outcomes (1)

• Prostate volume

  No minimum and maximum values, higher scores mean a worse outcome.

  The first month and the sixth month

Secondary Outcomes (3)

• International prostate symptom score

  The first, third and sixth month

• Quality of life score

  The first, third and sixth month

• International Index of Erectile Function

  The first, third and sixth month

Study Arms (3)

Control group

EXPERIMENTAL

Drug: alpha receptor antagonist

Low dose group

EXPERIMENTAL

Drug: alpha receptor antagonist; Drug: Low dose Tranilast

High dose group

EXPERIMENTAL

Drug: alpha receptor antagonist; Drug: High dose Tranilast

Interventions

alpha receptor antagonist DRUG

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

Control group; High dose group; Low dose group

Low dose Tranilast DRUG

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

Low dose group

High dose Tranilast DRUG

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

High dose group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yifeng Jing: lead

Study Sites (2)

Shanghai General Hospital

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

RECRUITING

Shanghai General Hospital

Shanghai, 200086, China

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

tranilast

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Yifeng Jing

CONTACT

+86-13918839913; jyf_123@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: For patients who meet the inclusion criteria, the control group takes oral alpha receptor antagonists (according to the dosage specified in the instructions for treating BPH) (n=10); Low dose group: oral administration of 100mg TID of tranilast capsules (Qu Ke Shen, Yao Da Pharmaceutical)+oral administration of alpha receptor antagonist (according to the dosage specified in the instructions for treating BPH) (n=10); The high-dose group received oral administration of 200mg TID of tranilast capsules (Qu Ke Shen, Yao Da Pharmaceutical) and oral administration of alpha receptor antagonists (according to the instructions for treating BPH) (n=10). Take medication continuously for 6 months. This trial allows the combination of various drugs taken by patients for the treatment of hypertension, diabetes, hyperlipidemia and other chronic diseases, and allows the combination of antibiotics.

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

CN (2)