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

NCT ID: NCT06159686

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2023-12-08

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).

Conditions

Uremic Pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

hemp group

They was assigned to apply the hemp-containing cream.

Group Type: EXPERIMENTAL

Hemp

Intervention Type: DRUG

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

Control group

They was assigned to apply the placebo cream.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Hemp

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thammasat University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Suthiya Anumas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suthiya Anumas

Role: PRINCIPAL_INVESTIGATOR

Thammasat University

Locations

Thammasat

Pathum Thani, , Thailand

Countries

Thailand

References

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.

Reference Type: DERIVED

PMID: 39328960 (View on PubMed)

Other Identifiers

074/2566

Identifier Type: -

Identifier Source: org_study_id