Efficacy of Pravek PROCURE in patients suffering from Benign Prostatic Hyperplasia (enlarged prostate) along with urinary tract disorders

A prospective, Interventional, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Pravek PROCURE in Benign Prostatic Hyperplasia & Urinary Disorders - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/104177

Enrollment

Registered

2026-02-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients 18 years or older diagnosed with Benign Prostatic Hyperplasia (BPH) 2. Patients willing to give written informed consent. 3. Patients are fit and no need for any hospital administration. 4. Patients willing to perform all study related procedures including the use of study medicine, allow the physical and investigational tests/procedures and willing to document symptoms and medication.

Exclusion criteria

Exclusion criteria: 1. Patients with diabetes mellitus, hypertension, prostate and bladder carcinoma, prostatitis, neurogenic bladder, stricture urethra, vesical calculus and patients on those drugs, which were likely to affect bladder function 2. Patients with severe cardiovascular, kidney or liver disorders 3. Patients indicated for surgery with refractory retention and recurrent or persistent gross hematuria 4. Patients with renal impairment. 5. Unstable medical or psychiatric illness. 6. Chronic & acute disorders requiring hospital admission. 7. Known HIV-positive, Hepatitis B or C status. 8. Inability to carry out visits for the study. 9. Inability to maintain current medication regimen. 10. Inability or unwillingness to participate in all components of the study.

Design outcomes

Primary

Measure	Time frame
1. Decrease of AUA-SS score 2. Decrease in bladder outlet obstruction 3. Reduction in post-void residual urine 4. Improvement in urinary flow rate 5. Reduction in the incidence of urinary retention 6. Improvement in the quality of life (From Baseline to 90 days of treatment)Timepoint: From Baseline to 90 days of treatment	—

Secondary

Measure	Time frame
1. Drug safety: LFT & RFT 2. Incidence of Adverse events (AE) and Serious Adverse Events (SAE) during the study period 3. Patient compliance to the drug therapy 4. Improvement in haematological and biochemical parameters. (From Baseline to 90 days of treatment)Timepoint: From Baseline to 90 days of treatment	—

Countries

India

Contacts

Public ContactDr. Shrikant Patel

Mansarovar Global University

shrikantpatelsr@gmail.com7415206731

Outcome results