This study is to see the safety tolerability and efficacy of study medication (Dose I & II) compared to placebo in subjects with Benign Prostatic Hyperplasia

An exploratory double-blind placebo controlled randomized parallel group multi-centric study to evaluate the safety tolerability and efficacy of LinumLife EXTRA (Dose I & II) compared to placebo in subjects with Benign Prostatic Hyperplasia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/10/004065

Enrollment

Registered

2013-10-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Benign Prostatic Hyperplasia

Interventions

Intervention1: LinumLife Extra - Investigational product: 500mg capsule in the morning daily for 8 weeks Control Intervention1: Carboxy Methyl Cellulose - Placebo: 500mg capsule in the morning daily f

Eligibility

Inclusion criteria

Inclusion criteria: • Ages eligible for Study : 45 Years - 75 Years • Genders eligible for Study : Male • Newly diagnosed cases of BPH (i.e. Fresh cases) diagnosed by USG along with documented symptoms of BPH (frequency; urgency; night time urination; reduced flow etc) • American Urological Association (AUA) Symptom Index Score >= 13. • PSA equal to or less than 4 ng/mL ( 0 to • Residual urine volume > 30 ml to

Exclusion criteria

Exclusion criteria: Subjects on 5 â??alpha reductase inhibitors. Subjects on alpha 1 adrenergic antagonist (alpha blockers. Subjects on combination of 5 â??alpha reductase inhibitors and alpha-blockers(K/c/o BPH on medications) Subjects on anti-cholinergics

Design outcomes

Primary

Measure	Time frame
â?¢ Change in the American Urological Symptom Index ScoreTimepoint: Baseline to end of treatment (Day 56).	—

Secondary

Measure	Time frame
â?¢ Change in the Post Voiding Residual Urine volume in all treatment groupsTimepoint: Baseline to end of treatment (Day 56).	—

Countries

India

Contacts

Public ContactDr Navneet Sonawane

Vedic Lifesciences Pvt. Ltd.

navneet.s@vediclifesciences.com02242025706

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026