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Cannabis Oil for Protein-Energy Wasting in Hemodialysis
NCT03664141Phase 3
Key facts
- Status
- Withdrawn
- Start
- Sep 2018
- Primary completion
- Aug 2019
- Countries
- 1
- Sponsor
- Shamir Medical Center
- Modality
- Small Molecules
- Drugs
- cannabis oil
- Conditions
- protein-energy wasting (PEW)
01
Overview
Phase 3, randomised, double-blind trial in protein-energy wasting (PEW) comparing Cannabis oil with Placebo (2 arms). Primary endpoints: Overall incidence and prevalence of adverse events at 5 months and Change in appetite assessed by the Visual Analogue Scale at 5 months. Planned start Sep 2018; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Cannabis oil
1 drop of 3% cannabis oil once a day
Placebo
1 drop of regular oil (placebo) once a day
03
Who it enrols
Adult ESKD patients on maintenance hemodialysis for at least 3 months with Malnutrition-Inflammation Score (MIS) >= 6. Excludes patients with active malignancy, liver cirrhosis, severe heart failure (NYHA IV), or history of psychiatric disorders.
04
Endpoints
Primary
Overall incidence and prevalence of adverse events
Change in appetite assessed by the Visual Analogue Scale
Secondary
Change in nutritional status assessed by the Malnutrition-Inflammation Score
Change in Health Related Quality of Life assessed by short form 36
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