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Clinical Trials/CTRI/2024/10/074894
CTRI/2024/10/074894
Not yet recruiting
Phase 2

A Comparative Clinical Study to Evaluate The Efficacy of Shilobidadi Tailam Uttarabasti and Shilobidadi Tailam Matrabasti Followed by Shilodbidadi Kashayam in the Managment of Vatastila with special refference to Benign Prostatic Hyperplasia

DrMADHUSUDAN REDDY1 site in 1 country40 target enrollmentStarted: October 15, 2024Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
DrMADHUSUDAN REDDY
Enrollment
40
Locations
1
Primary Endpoint
Relief from subjective parameters like pain in urinary bladder and difficulty in micturation,within 10 to 12 weeks

Overview

Brief Summary

Benign Prostate Hyperplasia (BPH) is a benign enlargement of prostate which occurs after 50  years. Usually between 60 and 70 years with age testosterone level drops slowly, but fall of estrogen level is not equal. The prostate enlarges through intermediate peptide growth factor, so that increases pressure on the urethra and results in urinary symptoms, such as increased frequency of micturition, Dysuria and urgency. Prevalence of BPH shows 20% in men aged 41–50yrs, 50% in men aged 51–60yrs and >90% in men older than 80yrs. At age 55yrs, approx. 25% of men report obstructive voiding symptoms, at the age of 75yrs, 50% of men complain of a decrease in the force of their urinary  stream

Hence It is the need of the hour to  understand BPH in terms of Ayurveda, so that an uncomplicated and patient friendly treatment can be  advised to the patients. Thus, Shilodbidadi tailam Uttara Basti & Matra Basti followed by Shilodbidadi Kashayam as a shamana aushadhi in both groups are adviced. Keeping all these facts in  mind,“A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF  SHILODBIDADI TAILAM UTTARABASTI AND SHILODBIDADI TAILAM MATRABASTI, FOLLOWED BY SHILODBIDADI KASHAYAM IN THE MANAGEMENT OF  VATASTHILA WITH SPECIAL REFERENCE TO BENIGN PROSTATIC HYPERPLASIA” is undertaken.

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 60.00 Year(s) (—)
Sex
Male

Inclusion Criteria

  • Patient presenting clinical features of vatastila Patient diagnosed with bph grade 1,grade 2 and grade 3 Patient having score mild to moderate in international prostate symptoms score will be included Patient fit for basti karma.

Exclusion Criteria

  • Patient having ca of prostate,uti,urethral stricture,hematurie,uremia,renal failure Patient having major systemic illeness like tb,uncontrolled diabetis mellitus Patients with acute retention of urine who need surgical intervention.

Outcomes

Primary Outcomes

Relief from subjective parameters like pain in urinary bladder and difficulty in micturation,within 10 to 12 weeks

Time Frame: Relief from subjective parameters like pain in urinary bladder and difficulty in micturation | within 10 to 12 weeks

Secondary Outcomes

  • Improvement in the size reduction of prostate(Improvement in post voidal residual urine volume via usg)

Investigators

Sponsor
DrMADHUSUDAN REDDY
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

DrMADHUSUDAN REDDY

Taranath goverment ayurvedic medical college and hospital,bellary.583101

Study Sites (1)

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