A confirmatory, randomized, double-blind, placebo controlled clinical investigation to evaluate the clinical performance and safety of Luvos® Healing Earth mikrofein for oral use in subjects with hypercholesterolemia

A confirmatory, randomized, double-blind, placebo controlled clinical investigation to evaluate the clinical performance and safety of Luvos® Healing Earth mikrofein for oral use in subjects with hypercholesterolemia - 2020-01 LUVCOL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024780

Enrollment

Registered

2022-02-22

Start date

2022-03-16

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

E78.0

Interventions

Group 1: Luvos® Healing Earth mikrofein Granules, (sachets) p.o. 3 x daily for 8 weeks. CE certified medical device CE0044 Group 2: Placebo preparation (sachets) p.o. 3 x daily for 8 weeks.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Males aged > 18 years, postmenopausal females Hypercholesteremia as indicated by LDL-Cholesterol 150 - 190 mg/dl, or higher if there are contraindications for treatments with statins or patients are not willing to take statins. Willingness and capability to sign the Informed Consent Form. Willingness not to change diet, lifestyle or physi cal activity over the next 8 weeks.

Exclusion criteria

Exclusion criteria: Individuals with any medical conditions that render the patient unsuitable for inclusion into the trial in the assessment of the investigator. Triglyceride blood levels > 200 mg/dl. Documented underlying allergic condition against Healing Earths. Familiar hypercholesterinemia. Medication against hypercholesterolemia in the last 4 weeks prior to the clinical investigation. Individuals who are not in sufficient health status as determined by the outcome of medical history, physical assessment, and clinical judgment of the investigator. Individuals who are not able or willing to follow the required clinical investigation procedures for the whole period of the clinical investigation. Previously diagnosed with chronic renal failure, liver disease, malignancies (past 5 years).

Design outcomes

Primary

Measure	Time frame
Difference of LDL-cholesterol at baseline and at 8 weeks of treatment	—

Secondary

Measure	Time frame
- LDL-Cholesterol in serum at 4 weeks - Percent (%) of patients with a reduction from initial LDL-Cholesterol levels of at least 20%, after 4 / 8 weeks of treatment. - Safety of Luvos® Healing Earth in subjects with hypercholesterolemia will be evaluated by the following assessments: * Incidence of treatment emergent AEs * Incidence of serious AEs Exploratory Parameters: Effects of Luvos® Healing Earth on total-cholesterol, non-HDL-cholesterol, HDL-cholesterol, triglycerides, Lipoprotein(a), CRP, Glucose, HBA1c, Creatinine, Hematology-parameters.	—

Measure

Time frame

- LDL-Cholesterol in serum at 4 weeks - Percent (%) of patients with a reduction from initial LDL-Cholesterol levels of at least 20%, after 4 / 8 weeks of treatment. - Safety of Luvos® Healing Earth in subjects with hypercholesterolemia will be evaluated by the following assessments: * Incidence of treatment emergent AEs * Incidence of serious AEs Exploratory Parameters: Effects of Luvos® Healing Earth on total-cholesterol, non-HDL-cholesterol, HDL-cholesterol, triglycerides, Lipoprotein(a), CRP, Glucose, HBA1c, Creatinine, Hematology-parameters.

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Countries

Germany

Outcome results

None listed

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