A clinical study to assess the Efficacy and Safety of SAW-1720 in Benign Prostate Hyperplasia patients
- Conditions
- Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
- Registration Number
- CTRI/2020/09/027521
- Lead Sponsor
- Akay Natural Ingredients Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.At screening, subject has an International prostatic symptom score greater than 7
2.BPH subjects with a history of recurrent lower urinary tract infection for at least 2 months
3.Must be willing and able to give informed consent and comply with the study procedures
1Has a history of prostate cancer or carcinoma of the prostate or subjects with known history of serum PSA concentration > 4 ng/ml must have prostate cancer ruled out to the satisfaction of the investigator.
2Has a residual void volume > 200 ml
3History of Neurogenic bladder dysfunction, Has bladder neck contracture or urethral stricture,Serious medical co-morbidities like uncontrolled diabetes, hypertension and cardio vascular disorders, neuropathy, liver damage, renal failure or respiratory tract infection.Any prior surgery which could induce dysuria,Use of any other herbal medications for treatment of BPH, associated symptoms and Erectile Dysfunction in past 1 month,Diuretics or drugs with antiandrogenic or alpha-receptor properties in the preceding 3 months.
4Subjects allergic to herbal products or any component of the study product
5Known HIV or Hepatitis B positive or any other immuno-compromised state
6Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
7Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method