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A clinical study to compare the effect of two drugs - patala kshara in tilataila and trikantakadi guggulu in patients with Benign Prostatic Hyperplasia.

Phase 3
Conditions
Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Registration Number
CTRI/2024/02/062595
Lead Sponsor
Dr Subi N H
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

•Patients with LUTS secondary to BPH and diagnosed by Transabdominal Ultrasound.

•BPH with IPSS score minimum 5.

•Patients who are willing to provide written informed consent

Exclusion Criteria

•Known cases of Prostatitis, Carcinoma Prostate and those who have undergone any surgery for Prostate.

•Known cases with complications of BPH like acute urinary retention, haematuria, hydronephrosis and renal insufficiency.

•Known cases of stricture of urethra, congenital contracture of bladder neck and bladder polyps and diverticula.

•BPH patients with severe cardiac disease, uncontrolled diabetes mellitus and immuno-compromised.

•Those who are contraindicated for the internal use of kshara.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary outcome– International Prostate Symptom Score (IPSS) and QOL will be assessed using <br/ ><br>validated questionnaire to quantify the reduction in LUTS .Timepoint: At baseline, 31st day and 61st day.
Secondary Outcome Measures
NameTimeMethod
Change in Post-Void Residual urine volume (PVR) & Prostate Volume (PV) will be assessed using Transabdominal Ultrasound.Timepoint: At baseline & after 60 days
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