CTRI/2021/03/031681Not yet recruitingPhase 1
A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Pashanabheda Kashaya And Paataladi Kashaya In The Management Of Vatashthila With Special Reference To Benign Prostatic Hyperplasia
Dean Parul Institute of Ayurved1 site in 1 country40 target enrollmentStarted: October 3, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- symptoms like frequency, urgency, nocturia weakstream of urine etc
Study Overview
Brief Summary
Ø Benign prostatic hyperplasia involves the stromal and epithelial elements arising in periurethral and transitional zone of the gland.Ø The enlargement of prostate exerts pressure on prostatic urethra which produces obstructive urinary symptoms like increase frequency of urination, dysuria , urgency , dribbling of urine, nocturia etc.Ø Mutraghat is an important disease in group of Mutramaragrogas as described in Ayurvedic texts. Ø Benign prostatic hyperplasia is one of the most common obstructive Uropathy affecting the aging male. The term Mutraghata is derived from word Mutra and Aghata which means obstruction & suppresion of urine outflow.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 40.00 Year(s) to 85.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Male aged between 40 to 85years -Having clinical features of Vatashtila or BPH like Granthivat Adhmana Mutrasangha Basti vedana Dribbling micturition Nocturia Increased frequency Urgency Weak stream Intermittency Straining Sensation of incomplete emptying.
Exclusion Criteria
- •K/C/O uncontrol diabetic mellites,hypertension •CA prostate • Urethral stricture •Bladder neck stenosis •Neuropathy bladder dysfunction •Impaired renal function •Prostate (grade 4) •Patient indicated for prostectomy •Haematuria secondary to renal & bladder stone, •Anaemic patient with Hb below 6 gm%.
Outcomes
Primary Outcomes
symptoms like frequency, urgency, nocturia weakstream of urine etc
Time Frame: 28 days
Secondary Outcomes
- symptoms like frequency, urgency, nocturia weakstream of urine etc(28 days)
Investigators
Study Sites (1)
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