to see the effect of Standard medical therapy along with rifaximin intervention vs. standard medical therapy alone on muscle wasting in patients with cirrhosis : A PILOT Randomized Controlled Trial

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

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051474

Enrollment

Registered

2023-04-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

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: Standard medical therapy plus rifaximin: All patients will receive medical therapy according to the standard guidelines for the management of the etiology and complications of chronic l

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with cirrhosis (Child A and B) and sarcopenia

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

Measure	Time 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: 6 months	—

Secondary

Measure	Time 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: 6 months	—

Countries

India

Contacts

Public ContactAnoop Saraya

Deptt of Gastroenterology and Human Nutrition Unit All India Institute of Medical Sciences New Delhi

ansaraya@yahoo.com9868397203

Outcome results

None listed

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