Clinical trial on Algae Extract in Healthy Adults to improve immunity

A Randomized, Double-Blind, Placebo-Controlled Trial to evaluate the safety and efficacy of Algae Extract (Ulva lactuca) in healthy adults. - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097278

Enrollment

Registered

2025-11-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

None listed

Interventions

Intervention1: Algae Extract (Ulva lactuca): Dose:300mg,Doasgeform:Capusle, Duration 28days, 1 capsule per day prior to dinner Control Intervention1: Placebo: Dose:300mg,Doasgeform:Capusle, Duration

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy male and female subjects aged between 20-35 years. 2.BMI ranges from 18.5 - 30 kg per m2. 3.Subjects willing to give Informed Consent. 4.Subjects with a practice of exercise cycling running elliptical pushups swimming etc. with a frequency of at least 3 days per week. 5.Agree not to use any medication prescription and over the counter including vitamins and minerals and any alternative medications during the course of this study. 6.Subjects were no known allergies to algae or shellfish. 7.No history of cardiovascular disease diabetes or cancer.

Exclusion criteria

Exclusion criteria: 1.Pregnancy or breast feeding. 2.Subjects with history of hypersensitivity to algae or shellfish. 3.Subjects with pre-existing severe systemic disease necessitating long-term medication. 4.Current use of medications that may interact with algae extract 5.History of cancer,including solid tumors hematologic malignancies and carcinoma in situ. 6.Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.

Design outcomes

Primary

Measure	Time frame
Primary outcomes: •Safety and tolerability assessments (adverse events, vital signs, complete hematology and biochemical profile) on baseline Visit, day 14 and day 28 •Improvement in serum antioxidant levels (GSH, MDA, CAT and GPx1) Timepoint: Baseline Visit, Day 28	—

Secondary

Measure	Time frame
Secondary Outcomes: •Change in Nrf2 from baseline to day 28 •Change in serum inflammatory markersTimepoint: Baseline Visit, Day 28	—

Countries

India

Contacts

Public ContactDr Ashok Godavarthi

Radiant Research Services Private Limited

surya.ashok@gmail.com09880999297

Outcome results