RecruitingNot ApplicableNCT07534241

Hepatoprotective Effects of Reishi Mushroom- (Ganoderma Lucidum) Among Metabolic Dysfunction-associated Fatty Liver Disease Patients


Sponsor

University of Lahore

Enrollment

102 participants

Start Date

Oct 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This 12-week RCT investigates the hepatoprotective and immunomodulatory effects of Ganoderma lucidum combined with a probiotic-rich diet in adults with MAFLD, assessing liver enzymes, lipid profile, inflammation, gut microbiota, and oxidative stress. Findings are expected to show dose-dependent improvements in hepatic fat, insulin resistance, and inflammatory markers, potentially reducing reliance on pharmacotherapy in


Eligibility

Min Age: 35 YearsMax Age: 65 Years

Inclusion Criteria7

  • Adults aged 35-65 years
  • BMI between 18.5 and 30 kg/m².
  • Complete Blood Count test ranges, WBC < 4,000-11,000 cells/µL, RBC Men < 4.5-6.0 / Women 4.0-5.5 million/µL, Hemoglobin: Men < 13.5-17.5 / Women 12.0-15.5 g/dL, Platelets < 150,000-450,000 cells/µL.
  • Lipid profile test markers (elevated LDL, total cholesterol, or triglycerides less than 150mg/dL high 200-499mg/dL and 500 mg/dL are above high.
  • Liver function test markers, ALT > 56 U/L, AST>40 U/L, ALP>147 UL.
  • Inflammatory markers: CRP >3 mg/L, - IL-6 ≥3 pg/mL, TNF-α ≥8 pg/mL.
  • Elevated blood sugar levels, or hyperglycemia, refer to a typically above 126 mg/dL, fasting or 200 mg/dL post-meal.

Exclusion Criteria7

  • ● Diagnosed with severe cardiovascular disease, liver failure, or renal impairment.
  • Pregnant or lactating women.
  • Individuals currently on statins, ezetimibe, PCSK9 inhibitors, or any other lipid-lowering therapy.
  • Allergic to mushrooms.
  • Diagnosed with celiac disease or other chronic gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis).
  • History of malignancy.
  • Participation in another clinical trial within the last 3 months.

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Interventions

DIETARY_SUPPLEMENTreishi mushroom- (Ganoderma lucidum)

Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken alongside a probiotic-rich diet.

DIETARY_SUPPLEMENTPlacebo

STARCH CAPCULE

DIETARY_SUPPLEMENTReishi mushroom dried powder

Reishi mushroom dried powder ONCE A DAY

DIETARY_SUPPLEMENTReishi mushroom dried powder

Reishi mushroom dried powder TWICE A DAY


Locations(1)

Sana Noreen

Lahore, Pakistan

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NCT07534241


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