drugset / Trial / NCT06159686

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

NCT06159686 ↗

Phase 1/2 Completed 60 enrolled Thammasat University Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-09-15
Primary completion
2023-12-08
Completion
2023-12-08

Outcome

Met primary endpoint

paper the WI-NRS dropped to 2.6 in the cannabis group and 3.6 in the placebo group PMID 39328960 ↗

paper the mean difference after adjustment for baseline scores:-1.1, 95% CI, -2.1 to -0.2; P = 0.02 PMID 39328960 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Hemp Unknown — Topical

Indications

No indication recorded.