Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159686
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2023-11-28
Brief Title:
The Efficacy of Hemp-containing Cream Versus Placebo in the Treatment of Uremic Pruritus
Sponsor:
Thammasat University Hospital
Organization:
Thammasat University Hospital
Study Overview
Official Title:
This Study Aims to Compare the Efficacy of Hemp-containing Cream and a Placebo in the Treatment of Uremic Pruritus in Hemodialysis Patients Patients Were Randomly Assigned Either the Hemp-containing Cream or a Placebo and Evaluated the WI-NRS and Skindex-10 Scores at Week 2 4
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Uremic pruritus is a significant burden on hemodialysis patients affecting approximately 46 of individuals undergoing dialysis Various mechanisms including inadequate dialysis increased uremic toxins inflammatory cytokines parathyroid hormone phosphorus dry skin mast cell histamine secretion and nerve stimulation through μ-opioid receptors and nociceptors contribute to uremic pruritus Current treatments include antihistamines gabapentin moisturizer creams and capsaicin creams with limited success as only 10 of patients find relief Cannabinoids were also mentioned in uremic pruritus treatment but are less commonly used and there are no randomised controlled trial Cannabinoid binding to CB1 and CB2 receptors inhibits mast cell differentiation aggregation and histamine release whereas cannabinoid binding to TRP-iron receptors reduces peripheral nerve activation Thus cannabinoid seem to effective in relieving pruritus via various mechanisms
This study aims to assess the effectiveness of a hemp-containing cream in comparison to a placebo for treating uremic pruritus among hemodialysis patients
This study aims to assess the effectiveness of a hemp-containing cream in comparison to a placebo for treating uremic pruritus among hemodialysis patients
Detailed Description:
Eligible participants is randomly assigned in a 11 ratio to receive either a hemp-containing cream or a placebo then they are assessed for the severity of itching symptoms using the WI-NRS and their itch-related quality of life using the Skindex-10 score at baseline week 2 and week 4 of the study Additionally adverse effects are documented Data is collected by the research assistant and recorded in computer with locking password and also was validated with second assistant
We planned for a sample size of 60 participants to detect differences in itchinEligible participants is randomly assigned in a 11 ratio to receive either a hemp-containing cream or a placebo then they are assessed for the severity of itching symptoms using the WI-NRS and their itch-related quality of life using the Skindex-10 score at baseline week 2 and week 4 of the study Additionally adverse effects are documented Data is collected by the research assistant and recorded in computer with locking password and also is validated with second assistant
For statistical analysis continuous variables are compared using an unpaired t-test or Mann-Whitney U test as appropriate Categorical variables are compared using a Chi-square test or Fishers exact test The adjusted mean difference is used Analysis of Covariance ANCOVA adjusted by score at baseline
All statistical analyses were performed using Stata v170 StataCorp Texas
We planned for a sample size of 60 participants to detect differences in itchinEligible participants is randomly assigned in a 11 ratio to receive either a hemp-containing cream or a placebo then they are assessed for the severity of itching symptoms using the WI-NRS and their itch-related quality of life using the Skindex-10 score at baseline week 2 and week 4 of the study Additionally adverse effects are documented Data is collected by the research assistant and recorded in computer with locking password and also is validated with second assistant
For statistical analysis continuous variables are compared using an unpaired t-test or Mann-Whitney U test as appropriate Categorical variables are compared using a Chi-square test or Fishers exact test The adjusted mean difference is used Analysis of Covariance ANCOVA adjusted by score at baseline
All statistical analyses were performed using Stata v170 StataCorp Texas
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