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Combined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled Trial
There are many reports about efficacy of Cannabis in Crohn's disease but no controlled trials. The aim of the proposed trial is to investigate the efficacy of oil containing the cannabinoids THC and CBD given by mouth for induction of remission in Crohn's disease.
The investigators have recently published a retrospective observational study about the beneficial effect of cannabis in Crohn's disease. The investigators have also concluded a double blind placebo controlled study of Inhaled cannabis in the treatment of Crohn's disease. Both studies have shown significant symptomatic improvement of disease. However, objective parameters of inflammation were not measured. The question arises as to whether the observed improvement is merely symptomatic or due to a real change in inflammation. In addition, administration per os is a healthier option than smoking but the efficacy of oral cannabis was not investigated. The aim of the proposed study in to evaluate the efficacy of drops of cannabis oil in crohn's disease patients compared to placebo. Treatment success will be defined as a decrease of at least 100 points in CDAI after 8 weeks of treatment. Secondary aims: 1. Remission of disease i.e CDAI of less the 150 points. 2. Improvement of at least one point in Endoscopic disease activity index 3. Improvement of CRP and calprotectine 4. Improvement of blood cytokine levels 5. Improvement of at least 30 points in quality of life as measured by the SF 36. In addition the investigators will monitor side effects by questionnaires addressed to the patients and to a significant relative of the patients.
Age
20 - 85 years
Sex
ALL
Healthy Volunteers
No
Meir Hospital
Kfar Saba, Israel
Start Date
March 1, 2013
Primary Completion Date
June 1, 2018
Completion Date
June 1, 2018
Last Updated
March 8, 2019
50
ACTUAL participants
THC 5mg/ml and CBS 50mg/ml
DRUG
Placebo
DRUG
Lead Sponsor
Meir Medical Center
NCT06226883
NCT07184931
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06918808