Effect of dashamool shilajit vati on prostate enlargement

Phase 2/3

Not yet recruiting

Conditions: Benign prostatic hyperplasia. Ayurveda Condition: VATASHTHILA,

Registration Number: CTRI/2023/06/054488

Lead Sponsor: Ayurved seva sangh Ayurved Mahavidyalaya

Brief Summary: BPH is one of the most common senile disese in males.Almost each and every male is affected by this disease hampering the quality of life.Hence the whole world is looking for alternative safe and sure treatment.In Ayurvedic samhitas,BPH is clinically similar to Vatashtheela and here its management is discussed.We have decided to search remedial solution for this burning problem which should be safer ,cost effective and easily available.We have taken 2 groups-Group A which is a study group of 45 patients which will be treated with Dashamool shilajit vati 250 mg 2 bid for 3 months.Group B whichis a control group of 45 patients treated with Tab Tamsulosin Hydrochloride 400 mg 1 at HS for 3 moths.Assessment criteria is as per IPSS -International Prostate Symptoms Scoring.Analysis of data will be done by scientific methods with the help of statistician.All clinical findings are recorded in case record forms CRF.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Male

Target Recruitment: 90

Inclusion Criteria

Patients with clinical features of BPH like Increases frequency, Weak urinary flow, Urgency of micturation,Nocturia,Straining during micturation and feeling of incomplete emptying of bladder,having post voiding residual volume upto 200 ml,patients willing to participate in clinical trial.

Exclusion Criteria

diagnosed case of malignancy of prostate, urethral stricture, active UTI, Patients with uncontrolled DM, TB, Malignancy and HBV Patients with imapaired renal function other systemic disorders which can interfere with course of the treatment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in prostate size	3 months
Change in urine Frequency, Urgency of micturition, Nocturia, Straining during micturition	3 months

Secondary Outcome Measures

Name	Time	Method
Reduction in prostate size	Reduction in post voidal residual urine volume

Trial Locations

Locations (1): Arogyashala Rugnalaya
🇮🇳
Nashik, MAHARASHTRA, India
Arogyashala Rugnalaya
🇮🇳Nashik, MAHARASHTRA, India
Dr Devata Panchakshari
Principal investigator
9422308136
drdevata@rediffmail.com