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Ayurvedic Intervention as an add-on to Lifestyle Modification in MASLD

Ayurvedic Intervention as an add-on to Lifestyle Modification in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD):A Multimodal Study on Clinical, Inflammatory and Gut Microbiome - Metabolomic Outcomes (AIMS - MASLD) - AIMS - MASLD

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097222
Enrollment
128
Registered
2025-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

Interventions

None listed

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed cases of MASLD of either sex in the age group of 30 – 60 years will be included for the study

Exclusion criteria

Exclusion criteria: Patients diagnosed of any other forms of liver diseases like hepatitis, cirrhosis, HCC; patients taking long term hepatotoxic medications like NSAID, rifampicin, corticosteroids or already taking supplementary medicines for fatty liver, patients consuming tobacco, alcohol or any other narcotic substances, pregnant or lactating women or any other condition which may jeopardize the study will be excluded from the trial

Design outcomes

Primary

MeasureTime frame
Changes In FIB-4 Score, CLDQ - MASH, Fat Attenuation Value Measured Through USAT, Liver Stiffness Value Measured Through Shear Wave Elastography of MASLD patientsTimepoint: Baseline, 29th day, 57th day, 85th day

Secondary

MeasureTime frame
Changes in LFT, lipid profile, inflammatory markers (CRP, IL-6, TNF – alpha), gut microbiome studies (16S rRNA Sequencing), metabolomic profiling of fecal and plasma samples and Fecal Short chain fatty acid (SCFA) profilingTimepoint: Baseline, 85th day

Countries

India

Contacts

Public ContactDr Remya E

Central Ayurveda Research Institute, Bhubaneswar, CCRAS

drremyaenair@gmail.com9447378133

Outcome results

None listed

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