Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Intervention1: Prostate24: Prostate24, 400 mg capsule (oral), twice a day for 60 days
Control Intervention1: Not applicable: Not applicable
Sponsors
Institute of Pharmacy Nirma University
Probiotic Smart LLC
Eligibility
Inclusion criteria
Inclusion criteria: i. Age above 45 years ii. Male participants diagnosed with BPH iii. Participant must not have taken any drug/ vitamin/ mineral/ dietary or herbal supplements for BPH 1 month prior to enrolment in the study and agrees to not use any new vitamins and/or minerals and/or dietary and/or herbal supplements until after study completion. iv. Participant must be able, willing and likely to fully comply with study procedures and restrictions. v. Participant willing to sign the informed consent
Exclusion criteria
Exclusion criteria: i. Evidence of renal disease (S. Creatinine > 1.5mg/ml) ii. Evidence of liver disease (AST/ALT >3 times of normal) iii. History of alcohol intake and smoking. iv. Participation in any other clinical trial with in the last 30 days v. History of intake of diuretics, Finasteride like drugs or dietary supplements for the treatment of BPH vi. History of intolerance or hypersensitivity to any of the content of the study drug vii. Any condition which in the opinion of the PI that is significant and can make the subject unsuitable for study or can place it under additional risk, such as intolerance, allergy to study drug, etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent changes in the overall signs and symptoms of BPH after the treatment with Prostate24 from baseline to 60 days. These will include, ââ?¬Â¢ Physical examination and DRE ââ?¬Â¢ PSA ââ?¬Â¢ CRP ââ?¬Â¢ Sr. Creatinine Timepoint: 0, 30, 60 day | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the adverse drug reactions of Prostate24Timepoint: 0, 30, 60 day | — |
Countries
India
Contacts
Public ContactShital Sharadkumar Panchal
Institute of Pharmacy Nirma University
Outcome results
None listed