Uremic Pruritus
Conditions
Keywords
Hemp, Uremic pruritus, hemodialysis, cannabinoid
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.
Detailed description
Eligible participants is randomly assigned in a 1:1 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 1:1 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 Fisher's exact test. The adjusted mean difference is used Analysis of Covariance (ANCOVA) , adjusted by score at baseline. All statistical analyses were performed using Stata v.17.0 (StataCorp, Texas).
Interventions
DRUGHemp
The application of the hemp-containing cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks.
DRUGPlacebo
The application of the placebo cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks.
Sponsors
Thammasat University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults ≥ 18 years old, diagnosed with end-stage kidney disease * Undergoing thrice-weekly chronic hemodialysis for more than 90 days * Exhibit a WI-NRS score of 3 or higher
Exclusion criteria
* Ahistory of hemp allergy * Pregnancy or breastfeeding * Dermatologic diseases * Adjustments to medications for controlling itch within the 14 days preceding the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WI-NRS (Worst Itching Numerical Rating scale) score at week 4 | week 4 | WI-NRS score will demonstrate the severity of itch at week 4. The minimum score is 0 and maximum score is 10. The higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WI-NRS at week 2 | week 2 | WI-NRS score will demonstrate the severity of itch at week 2. The minimum score is 0 and maximum score is 10. The higher scores mean a worse outcome. The minimum score is 10 and maximum score is 60. The higher scores mean a worse outcome. |
| Skindex-10 score at weeks 2 and 4 | week 2 and 4 | Skindex-10 score will demonstrate the itch-related quality of life at week 2 and 4. The minimum score is 10 and maximum score is 60. The higher scores mean a worse outcome. |
| the mean difference score between baseline and week 4 for WI-NRS and the Skindex-10 score | week 4 | The change of WI-NRS score and Skindex-10 score between baseline and week 4 represents the change of severity and QOL after complete study (week4) compare to baseline. The greater different scores mean a better outcome. |
Countries
Thailand
Outcome results
None listed