Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Intervention1: P grace (Pumpkin seed oil 320 mg) capsules: 1 capsule twice daily along with food morning and evening for 3 months.
Control Intervention1: NA: NA
Sponsors
Nutra Grace
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To improve IPSS in patients of BPHTimepoint: Visit 1 Screening Visit Day 0 Visit 2 Month 1 Week 4 Visit 3 Month 2 Week 8 Visit 4 Month 3 Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| To asses the change in the PSA levelTimepoint: Baseline and Month 3 (Week 12);To asses the change in the QOLTimepoint: Baseline and Month 3 (WEEK 12);To assess the adverse events and vital signsTimepoint: Baseline, Month 1 (Week 4), Month 2 (Week 8) and Month 3 (Week 12) | — |
Countries
India
Contacts
Public ContactMr Sunil Gupta
Pharexcelconsulting private Limited
Outcome results
None listed