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A clinical trial to study the effect of a drug, L-Taurine, for fatigue in patients with advanced liver disease

L-Taurine for fatigue in decompensated cirrhosis: a randomized controlled trial - NIL

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054455
Enrollment
220
Registered
2023-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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: L-Taurine: L-Taurine capsule 1 gram once daily orally for 12 weeks (along with optimized standard care) Control Intervention1: Standard care of decompensated cirrhosis: Optimized standa

Sponsors

Rajagiri Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than or equal to 18 years; 2. Child-Turcotte-Pugh score of 7 to 13 at presentation; 3. Fatigue Assessment Scale score more than or equal to 22

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years 2. Child-Turcotte-Pugh score less than 7 or more than 13 3. Fatigue Assessment Scale score less than 22 4. Patients who were hospitalized or underwent surgery in the preceding 6 weeks 5. Sick patients who require admission to the hospital 6. Patients on psychotropic medications 7. Patients with underlying malignancy (including hepatocellular carcinoma) 8. Patients with congestive cardiac failure 9. Patients who do not consent to the study

Design outcomes

Primary

MeasureTime frame
Variation in fatigue as assessed by change in Fatigue Assessment Scale scoreTimepoint: 12 weeks

Secondary

MeasureTime frame
Variation in fatigue as assessed by change in Fatigue Assessment Scale scoreTimepoint: 6 weeks;Variation in quality of life as assessed by change in WHO QOL IndexTimepoint: 6 weeks, 12 weeks

Countries

India

Contacts

Public ContactDr Susan John

Rajagiri Hospital

Ajit.Tharakan@rajagirihospital.com9495574984

Outcome results

None listed

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