Health TrialsbyHealthPanel

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

ConditionProstatic Hypertrophy, Benign
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age55-75
SponsorYifeng Jing

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • alpha receptor antagonist

    Drug

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

  • Low dose Tranilast

    Drug

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

  • High dose Tranilast

    Drug

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

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Control groupExperimental treatment 1 intervention
Group B: Low dose groupExperimental treatment 2 interventions
Group C: High dose groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Prostate volume

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

Time frame
The first month and the sixth month

Secondary outcomes

1

International prostate symptom score

The minimum value is 0, and maximum values 35. Higher scores mean a worse outcome.

Time frame
The first, third and sixth month
2

Quality of life score

The minimum value is 0, and maximum values 6. Higher scores mean a worse outcome.

Time frame
The first, third and sixth month
3

International Index of Erectile Function

The minimum value is 0, and maximum values 25. Higher scores mean a better outcome.

Time frame
The first, third and sixth month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yifeng Jing

Lead sponsor

Shanghai General Hospital, China

Sponsor institution

Source ClinicalTrials.gov
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