NCT06225258

Xanthohumol as an Adjuvant in the Treatment of Septic Shock

Recruiting now Phase 2 Last updated 4 July 2025

What this trial tests

Phase 2 trial testing Xanthohumol in Septic Shock in 50 participants. Currently enrolling.

Timeline

9 January 2023

Primary endpoint
30 October 2025

31 December 2025

Quick facts

Lead sponsor	Medical University of Lublin
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	50
Start date	9 January 2023
Primary completion	30 October 2025
Estimated completion	31 December 2025
Sites	1 location across Poland

Drugs / interventions tested

• Xanthohumol — full drug profile →

Conditions studied

• Septic Shock — all drugs for Septic Shock →
• Pneumonia — all drugs for Pneumonia →
• ARDS — all drugs for ARDS →

Sponsor

Medical University of Lublin

Who can join

18 and older, any sex, with Septic Shock or Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Septic shock (SS) is a life-threatening condition resulting from excessive inflammatory response to bacterial, viral or/and fungal infections. It is associated with dysregulation of the immune system, activation of immune cells, and massive release of cytokines, commonly known as the cytokine storm (CS). The clinical manifestations of SS depend on the initial site of infection. However, the classic symptoms are associated with severe dysfunction of the respiratory and cardiovascular systems, which are observed from the early phase. Respiratory insufficiency frequently requires different forms of oxygen supplementation, including mechanical ventilation and even extracorporeal oxygenation. The severity of respiratory and other organ dysfunction depends on the inflammatory response to the infection and circulating toxins, which correspond to excessive cytokine release. In the past years, several studies documented that reduction of SS-related inflammatory response and CS improved organ function and alleviated the clinical course of SS. Unfortunately, an effective strong anti-inflammatory without side effects medications has not yet been found. Therefore, the use of natural anti-inflammatory and antioxidant substances seems very promising.

Xanthohumol (Xn) is a natural prenylated chalcone extracted from the female inflorescences of hop cones (Humulus lupus) and possesses strong anti-inflammatory and antioxidant properties. It is widely used as a supplement to diet. Xanthohumol inhibits CS and has been showed to be an effective medication for reducing the severity of lung injury. It has been documented that Xn inhibits proinflammatory pathways in a different manner. A decrease in cytokine production and release can affect endothelial function and correct inflammatory-related vascular hyperpermeability, reducing uncontrolled water shift to extravascular space and then tissue edema. Clinical observation showed that administration of Xn alleviated clinical course, improved respiratory function, and reduced mortality in critically ill COVID-19 patients. Xanthohumol is safe and well tolerated by humans, and no adverse effects have been reported yet. Based on its strong anti-inflammatory and antioxidative properties, it can be speculated that the use of Xn can effectively reduce the inflammatory response and improve the clinical course in SS patients.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Towards personalized medicine: a scoping review of immunotherapy in sepsis.
   Slim MA, van Mourik N, Bakkerus L, Fuller K, et al · · 2024 · cited 38× · PMID 38807151 · DOI 10.1186/s13054-024-04964-6
2. Synergistic Anticancer Activity of Plumbagin and Xanthohumol Combination on Pancreatic Cancer Models.
   Palanisamy R, Indrajith Kahingalage N, Archibald D, Casari I, et al · · 2024 · cited 8× · PMID 38397018 · DOI 10.3390/ijms25042340
3. Advancing Brain Health Naturally: β-Caryophyllene and Xanthohumol as Neuroprotective Agents.
   Ivanova S, Dzhakova Z, Todorova V, Boyuklieva R, et al · · 2025 · cited 1× · PMID 41011595 · DOI 10.3390/molecules30183702