Treatment of Restless Leg Syndrome in patients with cirrhosis
Phase 3
Completed
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2019/02/017642
- Lead Sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Adults (19-60 years of age) with liver cirrhosis and idiopathic restless leg syndrome will be included
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Rate of RLS recurrence after the stopping the use of Pregabalin for six weeksTimepoint: RLS recurrence with in 6-12 weeks after stopping Pregabalin