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Clinical Trials/CTRI/2025/02/080616
CTRI/2025/02/080616
Not yet recruiting
Not Applicable

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

Dr VJD Gramin Ayurved Mahavidyalaya1 site in 1 country60 target enrollmentStarted: March 1, 2025Last updated:

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

Sponsor
Dr VJD Gramin Ayurved Mahavidyalaya
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Khushal Chouhan

Dr VJD Gramin Ayurved Mahavidyalaya

Study Sites (1)

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