FindTrial
Sign In

The effect of Rifaximin (an antibiotic drug commonly used in liver failure patients) and standard medical therapy vs standard medical therapy alone on myosteatosis (fat deposition in abdominal muscles), in patients with decompensated cirrhosis- a randomized controlled trial

The Effect of Rifaximin and Standard Medical Therapy Vs Standard Medical Therapy Alone on Myosteatosis in Patients with Decompensated Cirrhosis- A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/069984
Enrollment
80
Registered
2024-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: RIFAXIMIN PLUS STANDARD MEDICAL THERAPY ARM (GROUP A): Group A will receive standard medical therapy (SMT) as per guidelines along with Rifaximin (550 mg twice a day) orally, for 6 mon

Sponsors

PGIMER, CHANDIGARH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients of decompensated cirrhosis of any etiology 2) Evidence of myosteatosis on CT

Exclusion criteria

Exclusion criteria: 1. Patients with CTP score more than 10. 2. Patient with acute on chronic liver failure (ACLF) 3. Patients with active malignancy, hepatocellular carcinoma, and end-stage renal disease. 4. Patients having prior study enrolment or enrolment in another conflicting study. 5. Patients, not willing to participate in the study. 6. Individuals who have engaged in other clinical trials within the preceding 3 months. 7. Patients who have active evidence of infection. 8. Patients who had acute organic brain disease in the past 6 months. 9. Individuals experiencing severe hemodynamic instability, significant heart disease, pronounced bradycardia, or resting tachycardia. 10. Renal failure patients (creatinine clearance rate 60 mL/min/1.73 m2). 11. Patients with severe cognitive impairment, overt hepatic encephalopathy, or patients who had a physical disability. 12. Patients with HIV 13. Pregnancy 14. Post liver transplant patients 15. Exposure to Rifaximin in the previous 12 weeks 16. Known hypersensitivity to Rifaximin

Design outcomes

Primary

MeasureTime frame
To assess improvement in myosteatosis between RIFAXIMIN and SMT vs SMT alone group as evident in repeat NCCT abdomenTimepoint: 24 weeks—

Secondary

MeasureTime frame
1) Improvement in overall health related quality of life using FSS and HDQLI 2) Changes in total Body fat and visceral body fat as evident from bioimpedance analysis 3)Improvement in cognitive function using MOCA 5)Improvement in anthropometric measurements like BMI, Handgrip strength, Chair Stand Test and Balance Test 4)Incidence in adverse events between two groups. 5) Death and Hospitalization Timepoint: 24 weeks—

Countries

India

Contacts

Public ContactDr. Abhik Halder

Post Graduate Institute of Medical Education and Research, Chandigarh

abhikbaruipur97@gmail.com9830439593

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 9, 2026