Clinical evaluation of Siddha drug Velli parpam for prostatomegaly(Enlarge prostate)

Phase 2

Not yet recruiting

• Conditions: Benign prostatic hyperplasia withlower urinary tract symptoms,

• Registration Number: CTRI/2019/08/020979
• Lead Sponsor: Govt Siddha Medical College

Brief Summary

This is a Non randomized open clinical trial to study safety and efficacy of siddha drug VELLI PARPAM. The drug is given 130 mg once a day for 48 days. Clinical trial will be started after completion of preclinical and toxicological study. the drug VELLI PARPAM mentioned in siddhar kai kanda marunthu written by Balaramiya. During the trial all the study related data will be recorded and documented.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-09
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Isolated BPH symptoms BPH with lower urinary tract symptoms PSA (prostate specific antigen) with in the normal limit (<4nm/ml).
• USG prostate volume not more than 75 cc ( stage I – 25 cc to 50 cc and stage II – 50 cc to 75 cc).

Exclusion Criteria

• Age < 40 and > 80 yrs male Acute urinary retention CA prostate Acute and chronic renal failure Diabetic nephropathy Post TURP states Stricture urethra Urinary bladder calculus Any severe life threatening illness Nephrotic and nephritic syndrome PSA more than 4 nm/ml [5].
• USG Prostate volume more than 80CC Acute pyelonephritis Obstructive uropathy Prostatitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduced in clinical symptoms using IPSS assessing scale	48 days

Secondary Outcome Measures

Name	Time	Method
Monitoring the reduction in the size of the gland from stage II to stage I and from stage I to normal using ultrasonography	48 days

Trial Locations

Locations (1)

Aringar Anna Government Hospital of Indian Medicine; 🇮🇳 Chennai, TAMIL NADU, India

Aringar Anna Government Hospital of Indian Medicine

🇮🇳Chennai, TAMIL NADU, India

Dr E Vivekanandhan

Principal investigator

9865598155

vivekanandhan.bsms@gmail.com