Evaluation of Siddha Medicine for the management of difficulty of urination associated with Prostate enlargement in men

A randomized double blinded Placebo controlled Phase II Superiority Clinical study to determine the efficacy of Velvanga parpam Herbometallic Siddha Formulation in reducing Lower Urinary Tract Symptoms LUTS secondary to Benign Prostatic Hyperplasia BPH among males aged 40 to 80 years attending OPD at SCRU Tirupati - Vel BPH

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/113845

Enrollment

102

Registered

2026-07-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Interventions

Intervention1: Velvanka parpam: Velvanka parpam -130 mg, Twice a day with 1 gm of Butter as a Vehicle, before food for 30 days Control Intervention1: Placebo: Maize starch extra white / native maize

Eligibility

Inclusion criteria

Inclusion criteria: 1. Who have Lower Urinary Tract Symptoms secondary to BPH (LUTS-BPH) 2. International Prostate Symptoms Score (IPSS) measured by USG-KUB mild (0-7) and Moderate (8-19) symptoms. 3. Peak urinary flow rate; 5ml per second to 15 ml per second measures by Urine Flow meter. 4. Prostate Volume 30-80 cm3 measured by USG-KUB 5. Serum PSA less than 4 ng.

Exclusion criteria

Exclusion criteria: 1. History of urinary urethral obstruction due to stricture, valves, sclerosis or tumour at initiation 2. Presence of a penile implant or stent(s) in the urethra or prostate. 3. Any prior invasive prostate intervention (e.g., radio frequency (RF) ablation, balloon, microwave, or laser) or other surgical interventions of the prostate. 4. History of confirmed malignancy or cancer of prostate or bladder 5. Previous history of pelvic irradiation or radical pelvic surgery. 6. Compromised renal function defined as serum creatinine less than 2.0 mg per dl. 7. Patients who have participated in a drug study in the past 3 months

Design outcomes

Primary

Measure	Time frame
Efficacy assessments: The primary outcome measures will be validating and comparing the reduction IPSS of both the arms for the 45 days for treatment from the baseline to end of trial and secondarily the size of prostate volume, urine flow and exploring Siddha clinical parameters of the LUTS/BPH.Timepoint: 4 weeks (Drug administration) + 2 weeks (Follow-up)Total 6 weeks	—

Secondary

Measure	Time frame
Adverse Events, Liver Function, Renal Functions will be assessed to evaluate the safety of the study drugTimepoint: 6 weeks	—

Countries

India

Contacts

Public ContactDr K Samraj

Siddha Clinical Research Unit (CCRS)

samraj.mailme@gmail.com08772286659

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026