MedTrace Logo

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

NCT06159686 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-27

No results posted yet for this study

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.

Conditions

  • Uremic Pruritus

Interventions

DRUG

Hemp

The application of the hemp-containing cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks.

DRUG

Placebo

The application of the placebo cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks.

Sponsors & Collaborators

  • Thammasat University Hospital

    lead OTHER

Principal Investigators

  • Suthiya Anumas · Thammasat University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06159686 on ClinicalTrials.gov