The Efficacy of Hemp-containing Cream Versus Placebo in the Treatment of Uremic Pruritus
- Conditions
- Uremic Pruritus
- Interventions
- Drug: PlaceboDrug: Hemp
- Registration Number
- NCT06159686
- Lead Sponsor
- Thammasat University Hospital
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- Ahistory of hemp allergy
- Pregnancy or breastfeeding
- Dermatologic diseases
- Adjustments to medications for controlling itch within the 14 days preceding the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Placebo They was assigned to apply the placebo cream. hemp group Hemp They was assigned to apply the hemp-containing cream.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Thammasat
🇹🇭Pathum Thani, Thailand