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Investigating the effects of milk thistle supplementation on laboratory and clinical findings related to damage to various body organs following a patient's severe infection

Evaluation of the effect of nano silymarin supplementation on injury indicators in patients with sepsis or septic shock admitted to the intensive care unit

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201220049774N6
Enrollment
52
Registered
2025-08-06
Start date
2025-06-22
Completion date
Unknown
Last updated
2025-08-19

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

Conditions

Other sepsis. Other specified sepsis

Interventions

Intervention 1: Intervention group: 26 patients in the nanosilymarin supplement group will receive 70 mg nanosilymarin soft gelatin capsules, two together, twice a day for 5 days, along with an antibi

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 80 years Sepsis or septic shock in the intensive care unit (Sepsis is a life-threatening organ dysfunction caused by dysregulated host responses to infection. This organ dysfunction is defined by an acute change in the Sequential Organ Failure Assessment (SOFA) score of greater than or equal to 2 points from baseline following infection.) Signing the informed consent form

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
C-reactive protein (CRP). Timepoint: It will be recorded for each patient once upon entering the study and again after receiving the last dose of nanosilymarin. Method of measurement: Blood sample.

Secondary

MeasureTime frame
Serum creatinine. Timepoint: It will be recorded for each patient once upon entering the study and again after receiving the last dose of nanosilymarin. Method of measurement: Blood sample.;White blood cell count. Timepoint: It will be recorded for each patient once upon entering the study and again after receiving the last dose of nanosilymarin. Method of measurement: Blood sample.;Platelet count. Timepoint: It will be recorded for each patient once upon entering the study and again after receiving the last dose of nanosilymarin. Method of measurement: Blood sample.;Neutrophils to lymphocytes ratio. Timepoint: It will be recorded for each patient once upon entering the study and again after receiving the last dose of nanosilymarin. Method of measurement: Blood sample.;Platelet to lymphocyte ratio. Timepoint: It will be recorded for each patient once upon entering the study and again after receiving the last dose of nanosilymarin. Method of measurement: Blood sample.;Total bilirubin and direct bilirubin. Timepoint: It will be recorded for each patient once upon entering the study and again after receiving the last dose of nanosilymarin. Method of measurement: Blood sample.;Serum lactate. Timepoint: It will be recorded for each patient once upon entering the study and again after receiving the last dose of nanosilymarin. Method of measurement: Blood sample.;SOFA score. Timepoint: It will be recorded for each patient once upon entering the study and again after receiving the last dose of nanosilymarin. Method of measurement: Blood sample.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHesamoddin Hosseinjani

Mashhad University of Medical Sciences

hosseinjanih@mums.ac.ir+98 51 3180 1586

Outcome results

None listed

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