CTRI/2023/06/053734
Not yet recruiting
Phase 3
se of transcutaneous electric nerve stimulation for treatment of restless leg syndrome in chronic liver disease patients
Dr. Vimal Kumar Paliwal0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: G258- Other specified extrapyramidal andmovement disorders
- Sponsor
- Dr. Vimal Kumar Paliwal
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients of Chronic Liver Disease defined by progressive deterioration of liver function over 6
- •months, with age \> 18 years, attending Gastromedicine / Neurology OPD at SGPGI and
- •diagnosed with RLS as defined by the International RLS Study Group with Serum Ferritin \> 75 ng/ ml at presentation or Non improvement of RLS Symptoms after 6 weeks of Intravenous iron therapy in case with Serum Ferritin \< 75 ng/ml.
Exclusion Criteria
- •1\. Active alcohol intake
- •2\. Chronic Kidney diseasedefined by eGFR \< 60
- •3\. Recent Hospitalization / recent clinical worsening ( \< 4 weeks ) for deteriration of liver function of liver function as evidenced by new appearance or worsening of ascites or encephalopathy or jaundice, or reduction of urine output , or gastrointestinal bleeding
- •4\. Neurological illnesses like epilepsy disorder/ neuropathy / multiple sclerosis / spinal cord diseases 5\. Pregnancy 6\. Patients of rls on ongoing treatment with alpha 2 delta ligands / dopaminergic agonists / opioids . 7\. Localized skin eruptions 8\. Pacemaker
Outcomes
Primary Outcomes
Not specified
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