Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06190132
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2023-11-28
Brief Title:
The Effect of Omega-3 Fatty Acids Versus Gabapentin in Uremic Pruritus in Hemodialysis Patients
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Omega-3 Fatty Acids Versus Gabapentin in Uremic Pruritus in Hemodialysis Patients
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
omega-3 fatty acids versus gabapentin in uremic pruritus in hemodialysis patients
Detailed Description:
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 al2019 Patients in Group B 25 participants received gabapentin one capsule of gaptin 100mg thrice weekly post HD session KDIGO Clinical practice guidelines2019 Patients in the 2 groups received treatment for four weeks then after washout period6 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 al2010 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 5which mean no pruritus to 25 which mean most severe
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 al2010 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 5which mean no pruritus to 25 which mean most severe
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None