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A clinical trial to evaluate the safety and efficacy of Lycq® on subjects with high serum cholesterol levels

A randomized double blinded placebo controlled clinical trial to assess the tolerability and efficacy of Lycq® on cholesterol and lipoproteins in subjects with moderately elevated serum cholesterol levels

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/06/003786
Enrollment
80
Registered
2013-06-26
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: E780- Pure hypercholesterolemia

Interventions

Intervention1: Lycq tablets - twice daily: Phytosterol,a Plant sterol -twice daily for 01 month taken orally Control Intervention1: Placebo: Placebo -twice daily for 01 month taken orally

Sponsors

Edio Healthcare AB
Lead Sponsor
Edio Health Care Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: • Healthy as assessed by screening laboratory tests • Age 25 to 70 • Total serum cholesterol level > 5.2 mmol/l, • Normal liver, kidney and thyroid function • Signed written informed consent

Exclusion criteria

Exclusion criteria: • Participation in a clinical study 30 days prior to screening visit • Established /diagnosed phytosterolemia • Hypersensitivity towards any of the excipients • Consumption of cholesterol lowering medication 1 month prior to screening visit and throughout the study • Slimming or medically prescribed diet/prescription to special diet (vegan/gluten-free) • Alcohol or substance abuse (More than1 to 2 Drinks for Female and 2to 4 drinks for Males per day), within 6 months prior to or under the study. • History of unstable coronary artery disease within the previous 6 months • Transient Ischemic Attack (TIA) within 1 year prior to screening • Diabetes • Hyper-/hypo-thyroidism • Malignant disease, treatment ended less than 12 months prior to study start. • Pregnant or attempting to become pregnant or lactating during any period of the study • Lack of suitability for participation in the trial, for any reason, as judged by staff at the Investigating party

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of Lycq® on LDL-cholesterol levels on healthy subjects after 4 weeks of consumption compared to control in a parallel fashion Timepoint: At baseline,week 2,week 4 and week 8—

Secondary

MeasureTime frame
To control the effect of Lycq® consumption on serum total and HDL-cholesterol, triglyceride, apolipoprotein A1 and B levels after 4 weeks compared to control To assess the tolerability of Lycq® Timepoint: 04 months—

Countries

India

Contacts

Public ContactDr Harisha S

ICBio Clinical Research Pvt Ltd

harish@icbiocro.com09900111997

Outcome results

None listed

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