Clinical trial of beta sitosterol for prostate cancer

Randomized, Double-blind, Placebo-controlled, Pilot Study of Add-on Beta Sitosterol Supplementation on Treatment Response in Prostate Cancer Patients - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/063329

Enrollment

Registered

2024-02-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Beta Sitosterol: 320mg OD capsule for 3 months Control Intervention1: Placebo: Matching placebo capsules OD for 3 months

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males, age=18 years 2. Histologically proven prostate adenocarcinoma 3.Metastatic prostate cancer on ADT+/- Abiraterone acetate +/- Chemotherapy +/- Antiandrogen

Exclusion criteria

Exclusion criteria: 1. Brain or Leptomeningeal metastasis 2. Bilirubin, AST or ALT more than 2.5 times of the upper limit of normal levels. 3. Currently active Inflammatory bowel disease or Inflammatory bowel syndrome 4. History of any other malignancy in the last five years 5. History of recent surgery within 4 weeks of enrolment 6. Patients who are not willing to participate and will not provide signed informed consent

Design outcomes

Primary

Measure	Time frame
Change in PSA (Prostate specific antigen) levelsTimepoint: 3 months	—

Secondary

Measure	Time frame
Change in Plasma Ceramide levels & Quality of lifeTimepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Pooja Gupta

AIIMS New Delhi

drgupta.pooja@gmail.com26549257

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 30, 2026