The Efficacy of Hemp-containing Cream Versus Placebo in the Treatment of Uremic Pruritus

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).

• Hemp (Drug): The application of the hemp-containing cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks.
• Placebo (Drug): The application of the placebo cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks.

Primary outcomes

• 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 outcomes

• 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.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

• Results publication: Anumas S, Kuropakornpong P, Chakkavittumrong P, Tasanarong A, Pattharanitima P. Cannabis-Containing Cream for CKD-Associated Pruritus: A Double-Blind, Placebo Controlled Trial. Kidney Med. 2024 Aug 21;6(10):100894. doi: 10.1016/j.xkme.2024.100894. eCollection 2024 Oct. PMID 39328960

• Suthiya Anumas, Principal investigator, Thammasat University