Clinical trial

Omega-3 Fatty Acids Versus Gabapentin in Uremic Pruritus in Hemodialysis Patients.

Name
768/2022
Description
omega-3 fatty acids versus gabapentin in uremic pruritus in hemodialysis patients.
Trial arms
Trial start
2023-04-01
Estimated PCD
2023-07-15
Trial end
2023-07-30
Status
Completed
Treatment
Omega 3 fatty acid, gabapentin
To study the effect of omega 3 fatty acids on uremic pruritus in prevalent hemodialysis patients versus the effect of gabapentin
Arms:
Group A, Group B
Other names:
Gabapentin
Size
50
Primary endpoint
5 Dimensions itch scale, prostaglandin E2
14 weeks
Eligibility criteria
Inclusion Criteria: prevalent hemodialysis patients \>18 years undergoing dialysis who are co operative and not receiving topical or systemic treatment for uremic pruritus for at least 2 week patients who meet the international diagnostic criteria for uremic pruritus Exclusion Criteria: Patients with primary dermatological disease causing itching as atopic dermatitis, psoriasis, scabies, drug reaction Patients with any systemic disease that can cause pruritus as hepatic cholestasis , active infections (hepatitis B, and hepatitis c PCR positive, HIV) Patients under steroid treatment. current treatment of uremic pruritus. Concomitant malignancy (Hodgkins lymphoma, leukemia, multiple myeloma) Kidney transplantation (immunosuppressive medications Contraindications to omega 3 as patients using anticoagulants, or patients who have bleeding tendency, chronic diarrhea, history of malabsorption or allergic reaction to omega 3 Contraindications to gabapentin as in patients who have depression , suicidal thoughts, myasthenia Gravis, skeletal muscles disorder, patients who have history of allergic reactions to gabapentin
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2024-01-05

1 organization

1 product

1 indication

Indication
Uremic Pruritus