Effect of Prostate24 in prostate enlargement
- Conditions
- Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
- Registration Number
- CTRI/2022/10/046400
- Lead Sponsor
- Institute of Pharmacy Nirma University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean percent changes in the overall signs and symptoms of BPH after the treatment with Prostate24 from baseline to 60 days. These will include, <br/ ><br>�Physical examination and DRE <br/ ><br>� PSA <br/ ><br>�CRP <br/ ><br>�Sr. Creatinine <br/ ><br>Timepoint: 0, 30, 60 day
- Secondary Outcome Measures
Name Time Method To assess the adverse drug reactions of Prostate24Timepoint: 0, 30, 60 day