Exploring the Efficacy of P Grace: A Promising Intervention for Managing Benign Prostatic Hyperplasia (BPH) - An Open-Label, Single-Centric Clinical Study

Phase 4

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

• Registration Number: CTRI/2023/11/060343
• Lead Sponsor: utra Grace

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Aged 45 years and above male subjects.

Subjects must have low to moderate BPH symptoms.

Subjects having symptoms such as delay in initiating micturition,

hesitancy, weak urinary stream, straining to void, sensation of

incomplete emptying and terminal dribbling.

Subjects with increased residual urine volume.

USG prostate volume not more than 80 cc.

Nocturia, Urgency, bladder pain, dysuria.

Willingness to sign the informed consent, follow the protocol, and

participate in clinical trials voluntarily.

Exclusion Criteria

Patients with malignancy, Congenital deformities of urogenital tract or

any pathology other than BPH.

Patients with high Diabetes Mellitus Hypertension

systolic 140 mm Hg or higher diastolic 90 mm Hg or higher, Renal

disorders or any other systemic disease.

Patients planned for surgical treatment of BPH.

Urinary bladder calculus.

History of chronic prostatic diseases.

Patients with disturbed low BPH associated QoL scores.

Allergy or sensitivity to pumpkin seed oil.

Study & Design

• Study Type: Interventional
• Study Design: Not specified