A Study to Test the Safety and Effects of Neuherbs Deep-Sea Fish Oil Compared to an Inactive Supplement in Adults.

A Randomized, Prospective, Double-Blinded, Comparative Clinical Study to Evaluate the Safety and Efficacy of the Neuherbs Deep-sea Fish oil Compared with Placebo in Adults. - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/074932

Enrollment

Registered

2024-10-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: E789- Disorder of lipoprotein metabolism, unspecified Health Condition 2: D899- Disorder involving the immune mechanism, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of both sexes aged between 30 to 65 yrs. 2.BMI ranging from 25 to 30 Kg per m2 3.LDL Cholesterol level 1.3g per liter to 1.89g per liter

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women. 2.Patients currently taking lipid lowering drugs (including statins, fibrates. 3.Patients with high serum triglycerides (defined by more than 250 mg per dL) 4.Patients with any neoplastic, cardiovascular disorder or other concurrent medical illness (malabsorptive disorders, acute and chronic inflammation) confirmed based on medical history, physical examination and recent routine laboratory tests such as CBC and Urinalysis. 5.Patients with known history of hypersensitivity to the study drugs. 6.Alcoholic consumers and smokers 7.Currently or has been taking an investigational drug in the past 30 days.

Design outcomes

Primary

Measure	Time frame
1.Reduction in hsCRP levels between the two treatment arms at day 60 and day 90 of intervention 2.Reduction in Lipid Profile values between the two treatment arms at day 60 and day 90 of intervention Timepoint: Day 0, 30, 60 and 90	—

Secondary

Measure	Time frame
1.Change in BMI and body weight between the two treatment arms at day 60 and day 90 of intervention 2.Adverse events and relevant abnormal laboratory findings (serious/non-serious, expected/unexpected, related/non-related) between the two treatment arms 3.Percentage of patients with adverse events between the two treatment arms 4.Treatment discontinuation rates: Early discontinuation, discontinuation due to adverse events between the two treatment arms.Timepoint: Day 0, 30, 60 and 90	—

Measure

Time frame

1.Change in BMI and body weight between the two treatment arms at day 60 and day 90 of intervention 2.Adverse events and relevant abnormal laboratory findings (serious/non-serious, expected/unexpected, related/non-related) between the two treatment arms 3.Percentage of patients with adverse events between the two treatment arms 4.Treatment discontinuation rates: Early discontinuation, discontinuation due to adverse events between the two treatment arms.Timepoint: Day 0, 30, 60 and 90

—

Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com9739001749

Outcome results