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Study on the Effectiveness and Safety of Silibinin for Patients with Active Cushing’s Disease

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called Silycus® for patients with Cushing’s disease. Cushing’s disease is a condition where the body produces too much of a hormone called cortisol, which can lead to various health issues. The treatment being tested, Silycus®, contains an active substance known as silibinin, which is derived from milk thistle fruit. The purpose of the study is to evaluate whether Silycus® can help reduce or normalize the excess cortisol levels in patients with active Cushing’s disease.

Participants in the study will take Silycus® in the form of granules in a sachet, which they will consume orally. The study will last for a period of 12 weeks, during which the effects of the treatment on cortisol levels will be monitored. The study will also assess changes in clinical signs and symptoms of Cushing’s disease, such as body weight, blood pressure, and glucose control. Additionally, the safety of Silycus® will be evaluated by monitoring any adverse events that may occur during the study.

The trial aims to provide valuable information on the potential benefits of Silycus® for managing Cushing’s disease. By the end of the study, researchers hope to determine if Silycus® can effectively lower cortisol levels and improve the overall health of patients with this condition. The findings from this study could contribute to better treatment options for individuals living with Cushing’s disease.

1 joining the study

Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate and follow the study’s requirements.

Your medical records will be reviewed to confirm your diagnosis of Cushing’s disease.

2 initial assessment

An initial assessment will be conducted to measure your 24-hour urinary free cortisol (UFC) levels, late night salivary cortisol, and response to a low dose of dexamethasone. These tests help evaluate your current condition.

3 medication administration

You will begin taking Silycus®, which contains the active substance silibinin. This medication is provided in the form of granules in a sachet for oral use.

The dosage and frequency of administration will be adjusted based on your response to the medication. This process is known as dose titration.

4 ongoing monitoring

Throughout the study, your cortisol levels will be regularly monitored to assess the effectiveness of the treatment. This includes checking UFC, late night salivary cortisol, and response to dexamethasone.

Your clinical signs and symptoms, such as body weight, blood pressure, and glucose control, will also be evaluated.

5 safety assessment

The safety of Silycus® will be monitored by recording any adverse events you may experience. This helps ensure the treatment is safe for you.

6 final evaluation

After 12 weeks of treatment, a final evaluation will be conducted to determine the overall effectiveness and safety of the medication.

The study aims to see if your cortisol levels have normalized or decreased significantly, and if your clinical symptoms have improved.

Who Can Join the Study?

  • Must be an adult, meaning you are 18 years or older.
  • Can be either female or male.
  • Must have active Cushing’s disease. This will be confirmed by medical guidelines and records.
  • Must have a high level of cortisol in the body, which is a hormone. This is checked by:
    • 24-hour urine test showing cortisol levels 1.5 times above normal.
    • Late-night saliva test showing high cortisol levels in at least two tests.
    • Blood test after taking a small dose of a medicine called dexamethasone, showing cortisol levels higher than 1.8 micrograms per deciliter in the morning.
  • Must be on inadequate or not tolerated treatments for Cushing’s disease, with the possibility to stop these treatments for a short period.
  • If newly diagnosed with Cushing’s disease, you must not be a candidate for surgery or have surgery delayed beyond the study period.
  • Must be willing to provide written consent to participate in the study and follow the study requirements.

Who Cannot Join the Study?

  • Patients who do not have Cushing’s disease cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not willing to follow the study procedures cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with other serious health conditions that might interfere with the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had recent surgery or are planning to have surgery soon cannot participate.
  • Patients who have a history of drug or alcohol abuse cannot participate.
  • Patients who are unable to provide informed consent cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Azienda Ospedaliera di Padova Padua Italy
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Apogxyl Oxsiivgbaor Ugkctakasanqe Cykapozsomra Dizdo Sxhjzn E Dutjd Sibetkm Dc Tomavn Turin Italy

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

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
15.10.2021

Trial locations

Investigated drugs:

Silycus® is a medication being studied for its potential to help people with Cushing’s disease. Cushing’s disease is a condition where the body produces too much of a hormone called cortisol. This medication aims to reduce the amount of cortisol in the body to normal levels. The study is looking at how well Silycus® works by measuring cortisol levels in different ways, such as through urine and saliva tests, or by seeing how the body responds to another medication that usually lowers cortisol levels. The goal is to see if Silycus® can effectively manage the symptoms of Cushing’s disease by controlling cortisol production.

Cushing’s disease – Cushing’s disease is a condition caused by an excess of cortisol, a hormone produced by the adrenal glands. This overproduction is often due to a pituitary gland tumor that secretes adrenocorticotropic hormone (ACTH), which stimulates cortisol production. The disease progresses with symptoms such as weight gain, particularly around the abdomen and face, high blood pressure, and changes in skin appearance, including easy bruising and purple stretch marks. Muscle weakness and fatigue are also common as the disease advances. Over time, individuals may experience mood changes, such as depression or anxiety, and difficulties with glucose control, leading to diabetes. The progression of Cushing’s disease can lead to complications affecting various body systems if not managed.

Trial ID:
2024-518869-99-00
Protocol code:
SILYCUS-21
Trial Phase:
Therapeutic exploratory (Phase II)

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