Uremic Pruritus in Hemodialysis Patients Clinical Trial
Official title:
Omega-3 Fatty Acids Versus Gabapentin in Uremic Pruritus in Hemodialysis Patients.
omega-3 fatty acids versus gabapentin in uremic pruritus in hemodialysis patients.
Patients who were enrolled in the study used no antipruritic therapy for at least 2 weeks before the study. The patients were randomly assigned to Group A, or Group B. Patients in Group A (25participants) were allocated to treatment with omega-3 daily (2capsules of 1gm omega-3 a day) (Shayanpour et al.,2019). Patients in Group B (25 participants) received gabapentin (one capsule of gaptin 100mg thrice weekly post HD session) (KDIGO Clinical practice guidelines,2019) Patients in the 2 groups received treatment for four weeks then after washout period(6 weeks), the treatment was changed between the 2 groups. pruritus severity was assessed by 5D-Itch score before the study and at the end of each treatment period. Throughout the study, the level of PGE2 and the pruritus severity was measured at the baseline before treatment, after 4 weeks and after 14 weeks (post treatment) by 5-D itch scale. 5-D itch scale was made to be used for outcome measurement in clinical trials. It depends on five main domains for measurement of pruritus severity which are (duration, degree, direction, disability and distribution) (Elman et al.,2010). The score of each domain is made separately then the scores of all domains summed together to obtain the total 5-D score pruritus). Patients with score 5 or less considered having no itching and patients with scores from 6 to 25 considered itch patients. The total 5-D score can be classified into: 1. The score of 6-10 is considered mild pruritus. 2. The score of 11-20 is considered moderate pruritus. 3. The score of 21-25 is considered severe pruritus. So the study group will fulfill the following criteria : 1. According to 5D itch score a total score of 6-25 points 2. Meet the international diagnostic criteria for uremic pruritus. 3. Meet the exclusion criteria of the study. The total score can range from 5(which mean no pruritus) to 25 (which mean most severe ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03218501 -
A Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus
|
Phase 2 |