Comparing liquid versus capsule forms of phosphatidylcholine in patients with alcoholic liver disease, chronic hepatitis B, and metabolic liver disease

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What is this study about?

This clinical trial studies the effectiveness of two forms of Essentiale medication (liquid and capsules) in treating several liver conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Alcoholic Liver Disease, and Chronic Viral Hepatitis B. The main active substance in both forms is phosphatidylcholine, which is derived from soya beans. The purpose of the study is to determine if the liquid form of the medication works as well as the capsule form when added to standard treatment.

During the study, participants will receive either the liquid form of Essentiale (1800 mg), Essentiale capsules, or a placebo. The medication or placebo will be taken daily for 87 days. The liquid medication comes in stick packs containing 1.8g of the substance, while the capsules contain 300 mg each. All participants will continue their regular liver disease treatment throughout the study.

The study will monitor changes in liver disease symptoms such as tiredness, depression, stomach discomfort, sleep problems, loss of appetite, and nausea. The medications and placebos are designed to look, taste, and smell the same so that participants cannot tell which form they are receiving. This helps ensure that the study results are reliable and unbiased.

1 Initial assessment

You will be evaluated to confirm if you have one of these liver conditions: MASLD/MASH (liver disease related to metabolic problems), alcoholic liver disease, or chronic hepatitis B

Your symptoms will be assessed using a Global Overall Symptom (GOS) score, which includes: energy loss, depression, abdominal pain, fatigue, sleeping problems, appetite loss, and nausea

2 Treatment assignment

You will be randomly assigned to receive either:

Essentiale liquid (1800 mg once daily) with placebo capsules, or

Essentiale capsules (300 mg) with placebo liquid

3 Treatment period

The treatment will continue while maintaining your standard care for liver disease

You will need to take the assigned medication daily

Regular evaluations of your symptoms will be conducted using the GOS score

Your quality of life will be assessed using a specific questionnaire for liver disease

The study will continue until May 2026

4 Safety monitoring

Your health will be monitored throughout the study for any side effects

Any changes in your symptoms or new health issues will be recorded

5 Additional requirements

If applicable, you must participate in an alcohol withdrawal program

You may need to follow specific diet and exercise recommendations

Women who can become pregnant must use effective contraception during the study and for 30 days after

Men with partners who can become pregnant must use condoms along with their partner’s contraception during the study and for 30 days after

Who Can Join the Study?

  • Age between 18 and 70 years old
  • Must have symptoms such as:
    • Energy loss (feeling weak)
    • Feeling depressed
    • Stomach pain or discomfort
    • Tiredness
    • Trouble sleeping
    • Loss of appetite
    • Nausea (feeling sick)

    These symptoms must score 3 or higher on a special assessment scale

  • Must have been diagnosed by a doctor with one of these liver conditions:
    • Fatty liver disease related to metabolic problems
    • Liver disease caused by alcohol
    • Long-term hepatitis B infection
  • Must be currently receiving standard medical care for liver disease
  • Must agree to:
    • Stop drinking alcohol and participate in alcohol treatment if there is a history of alcoholism
    • Follow diet and exercise recommendations if required
  • Must sign an informed consent form
  • Must be willing to follow all study procedures and attend all required visits
  • Must be able to take oral medication
  • For women who can become pregnant: Must use effective birth control (such as hormonal contraceptives or IUD) during the study and for 30 days after
  • For men with partners who can become pregnant: Must use condoms and their partner must use effective birth control during the study and for 30 days after

Who Cannot Join the Study?

  • Patients under 18 years of age or over 65 years old
  • People with severe liver disease (a condition where the liver is severely damaged and cannot function properly)
  • Individuals with known allergies to any components of the study medication
  • Pregnant or breastfeeding women
  • People currently participating in other clinical trials
  • Individuals with autoimmune diseases (conditions where the body’s immune system attacks its own tissues)
  • People with uncontrolled diabetes mellitus (high blood sugar levels that are not well managed)
  • Individuals with serious heart conditions
  • People with severe kidney problems
  • Those who have had major surgery within the last 3 months
  • Individuals with active cancer or undergoing cancer treatment
  • People with history of drug or alcohol abuse within the past 6 months
  • Those unable to provide informed consent
  • Individuals who cannot follow study procedures or attend regular visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Eugastro GmbH Leipzig Germany
Multiprofile Hospital For Active Treatment Sveti Ivan Rilski 2003 OOD Dupnitsa Bulgaria
Endoskopia Sp. z o.o. Sopot Poland
Multiprofile Hospital For Active Treatment Dr. Bratan Shukerov AD Smolyan Bulgaria
MBAL Sveta Karidad EAD Plovdiv Bulgaria
ID Clinic Myslowice Poland
Bodyclinic Sp. z o.o. sp.k. Warsaw Poland
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Saarland University Hospital Homburg Germany
MBAL Dr. Ivan Seliminski – Sliven AD Sliven Bulgaria
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Medical Center Dr. Kalchev Ltd. Sofia Bulgaria
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd. Plovdiv Bulgaria
Pjsbd Cazyefm Mttv Eyrz Vdagdr Vratsa Bulgaria
Uffuiwjosg Mlhhvdatoxnnfuhro Hwsxluuo Fvv Astbwo Tuajveycj Kdkvb Al Ruse Bulgaria
Contqpg Mjvbhcbk w Łefoagon Lancut Poland
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Ntqowetitpvp Zohjxl Oitzpq Ztyyughzhw &jmxhelgunxuqt Onqcjylmukahi Katowice Poland
Mdlklpd Caoxwq Mdkaetcquu &mxkddr Bbhuga Burgas Bulgaria
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Uphxbdrubbuyzjxcmspq Rbtazcbtxrxmmcuhdp Neuruppin Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
11.02.2026
Germany Germany
Recruiting
11.02.2026
Poland Poland
Recruiting
11.02.2026

Trial locations

Essentiale® Liquid (EPL liquid) is a medication used to treat various liver conditions. It contains essential phospholipids that help protect and repair liver cells. The liquid form may be easier to take for some patients compared to capsules.

Essentiale® Capsules (EPL capsules) contain the same active ingredients as the liquid form, essential phospholipids, which support liver cell function and help in liver repair. The capsule form is a traditional way of taking this medication.

Both medications are used in addition to standard of care treatment for patients with liver conditions such as metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic dysfunction-associated steatohepatitis (MASH), alcoholic liver disease, and chronic viral hepatitis B.

Alcoholic Liver Disease – A condition that develops when years of excessive alcohol consumption damage the liver. The disease begins with fat accumulation in liver cells, which can progress to inflammation and scarring of liver tissue. The liver becomes enlarged and less efficient at performing its vital functions.

Chronic Viral Hepatitis B – A long-term viral infection of the liver caused by the hepatitis B virus. The infection leads to ongoing inflammation of liver tissue, which can last for many years. The virus gradually affects liver cells, causing them to become damaged and leading to changes in liver function.

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) – A condition where excess fat builds up in the liver due to metabolic problems, not related to alcohol consumption. This condition is closely linked to obesity, diabetes, and high blood pressure. When inflammation develops along with fat accumulation, the condition is called Metabolic Dysfunction-Associated Steatohepatitis (MASH). The liver becomes enlarged and its function may gradually decline over time.

Trial ID:
2025-521678-32-00
Protocol code:
LPS17913
Trial Phase:
Therapeutic confirmatory (Phase III)

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