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Standard medical therapy plus rifaximin vs. standard medical therapy alone for the management of sarcopenia in patients with cirrhosis

Standard medical therapy plus rifaximin vs. standard medical therapy alone for the management of sarcopenia in patients with cirrhosis: A PILOT Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/040923
Enrollment
60
Registered
2022-03-08
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Health Condition 1: K74- Fibrosis and cirrhosis of liver

Interventions

Intervention1: Standard medical therapy plus Rifaximin for 6 months: All patients will receive medical therapy according to the standard guidelines for the management of the etiology and complications

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with cirrhosis (Child A and B) and sarcopenia 2. Age: 18-60 years

Exclusion criteria

Exclusion criteria: 1. Patients with history of overt hepatic encephalopathy (HE) or those who develop HE during treatment 2. Patients with sepsis, active GI bleed or acute kidney injury 3. Known cases of hepatocellular carcinoma 4. Any severe chronic illness including congestive heart failure, chronic kidney disease, neuromuscular disorders or HIV 5. History of any chronic drug intake such as corticosteroids 6. History of drugs postulated to increase muscle mass such as testosterone, growth hormone, anabolic steroids

Design outcomes

Primary

MeasureTime frame
1. To compare the change in muscle mass at 6 months in patients receiving standard medical therapy (SMT) plus rifaximin compared to SMT alone.Timepoint: 0 and 6 months

Secondary

MeasureTime frame
1. To compare the change in muscle strength between the two groups at 6 months 2. To compare the change in muscle performance between the two groups at 6 months 3. To compare the change in quality of life between the two groups at 6 months 4. To compare the change in the plasma levels of ammonia between the two groups at 6 months Timepoint: 0 and 6 months

Countries

India

Contacts

Public ContactDeepak Gunjan

All India Institute of Medical Sciences

drdg_01@rediffmail.com9811225431

Outcome results

None listed

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