A Randomised Controlled Clinical Trial to Assess The Efficacy of Haritakyadi Kwath and Yavakshar in Management of Vatastheela W.S.R to Benign Prostatic Hyperplasia
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr VJD Gramin Ayurved Mahavidyalaya
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Subjective criteria
Overview
Brief Summary
Benign Prostatic Hyperplasia (BPH), is a common condition
among aging males, characterized by prostate gland enlargement
leading to lower urinary tract symptoms. It expresses both the
obstruction and the irritability of the urinary system.
Vatashtheela is a hard, elevated, mobile swelling. It is one of the
thirteen types of Mootraghata. Vatashtheela reflects the symptomsimilar to the Lower Urinary Tract Symptoms (LUTS) and may be
corelated with Benign Prostatic Hyperplasia (BPH). Vatashtheela is a condition of obstructive uropathy which may present with either partial or complete retention of urine.
The prevalence of Benign Prostatic Hyperplasia increases
after the age of 40 years, autopsy studies have observed a histological prevalence of 8%, 50%, and 80% in the 4th, 6th and 9th decade of life, respectively. Since Benign Prostatic Hyperplasia is not a rapid progressive disease so the management of Benign Prostatic
Hyperplasia can be achieved by adapting conservative measure and lastly surgical intervention as it may lead to many complications like postoperative morbidity, impotence, retrograde ejaculation etc. Apart from that a cumulative probability for reoperation has been estimated up to 15% of operated cases within 8-10 years. Although administration of conservative modern treatment i.e. hormone therapy has good advantages but has side effects like loss of libido, Impotence, gynecomastia etc.
Hence, Ayurveda may be more effective as well as safe
for conservative management of B.P.H.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 40.00 Year(s) to 80.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Patients presenting with classical signs and symptoms of Benign Prostatic Hyperplasia.
Exclusion Criteria
- •CA Prostate Urethral stricture Benign tumor of urethra Malignant tumor of urethra Urethral injury Urethral calculi Age above 80 years and below 40 years Patients with systemic diseases like uncontrolled Hypertension (more than 150/90 mm Hg) and uncontrolled Diabetes mellitus (RBS more than 180 mg/dl), Tuberculosis, STD, HIV, HBSAg.
Outcomes
Primary Outcomes
Subjective criteria
Time Frame: Before treatment and after treatment and follow up at 15 and 30 days
Quality of life due to urinary symptoms
Time Frame: Before treatment and after treatment and follow up at 15 and 30 days
International prostate symptoms score IPSS
Time Frame: Before treatment and after treatment and follow up at 15 and 30 days
Objective criteria
Time Frame: Before treatment and after treatment and follow up at 15 and 30 days
Prostate size (volume) by USG
Time Frame: Before treatment and after treatment and follow up at 15 and 30 days
Residual urine volume by USG
Time Frame: Before treatment and after treatment and follow up at 15 and 30 days
Urine flow rate
Time Frame: Before treatment and after treatment and follow up at 15 and 30 days
Secondary Outcomes
- Decrease in symptoms of Vatastheela and Quality of life due to urinary symptoms(18 months)
Investigators
Dr Khushal Chouhan
Dr VJD Gramin Ayurved Mahavidyalaya