Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Pregabalin: Oral administration of 75 mg daily dose of Pregabalin for six weeks
Control Intervention1: Not applicable: Not applicable
Sponsors
Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow India
Eligibility
Inclusion criteria
Inclusion criteria: Adults (19-60 years of age) with liver cirrhosis and idiopathic restless leg syndrome will be included
Exclusion criteria
Exclusion criteria: (i) Hemodynamic instability (ii) Recent ( <4 weeks) deterioration of liver function as evidence by new appearance or worsening of ascites or encephalopathy or jaundice, or reduction of urine output, or gastrointestinal bleeding (iii) Known case of peripheral neuropathy (iv) Uncontrolled systemic illness such as diabetes mellitus, chronic kidney disease, defined as estimated GFR <60ml/min, hypothyroidism or (v) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effectiveness of a short course, low dose pregabalin in treatment of RLS in patients with cirrhosisTimepoint: Response after 6 weeks of Pregabalin use at once daily dose of 75 mg | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of RLS recurrence after the stopping the use of Pregabalin for six weeksTimepoint: RLS recurrence with in 6-12 weeks after stopping Pregabalin | — |
Countries
India
Contacts
Public ContactAmit Goel
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI)
Outcome results
None listed