Crohn's Disease Clinical Trial
Official title:
Combined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled Trial
Verified date | March 2019 |
Source | Meir Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Patients with a diagnosis of Crohn's disease of at least 3 months duration, which was proved by either endoscopy or appropriate imaging study. 2. Patients who have failed treatment with either 5 ASA or corticosteroids or immunomodulators or biologic agents, or steroid dependant patients, or patients who were treated by the above mentioned drugs and could not tolerate them due to side effects. 3. Age 20 or older. 4. Able to sign informed concent 5. Active Crohn's disease with a CDAI 200 or more. Exclusion Criteria: 1. Patients with a diagnosis of a mental disorder 2. Patients who by the judgment of their physician are likely to develop drug addiction. 3. Pregnant women or women who are intending to become pregnant 4. Patients with a known cannabis allergy 5. Patients who are not capable of giving an informed consent 6. Patients with an impending operation due to Crohn's disease. |
Country | Name | City | State |
---|---|---|---|
Israel | Meir Hospital | Kfar Saba |
Lead Sponsor | Collaborator |
---|---|
Meir Medical Center |
Israel,
Naftali T, Lev LB, Yablecovitch D, Half E, Konikoff FM. Treatment of Crohn's disease with cannabis: an observational study. Isr Med Assoc J. 2011 Aug;13(8):455-8. Erratum in: Isr Med Assoc J. 2011 Sep;13(9):582. Yablekovitz, Doron [corrected to Yablecovitch, Doron]. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety and side effects | we will monitor side effects by questionnairs adressed to the patients and to a significant relative of the patients.both patient and a significant realitive (parent, spouse) living in the same residence with the patient will recive a quationnair monitiring cannabis use, with aminimus score of 0 (not dependant, no side effects) to a maximum score of 15 (very dependant, sever side effects) | 8 weeks | |
Primary | Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment. | The aim of the proposed study in to evaluate the efficacy of drops of cannabis oil in crohn's diseas patients compared to placebo. Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment. | 8 weeks | |
Secondary | Remission of disease | 1. Remission of disease i.e CDAI of less the 150 points. | 8 weeks | |
Secondary | endoscopic improvment | 2. Improvment of at least one point in Endoscopic disease activity index | 8 week | |
Secondary | Improvment of CRP and calprotectine | CRP and calprotectine will be measured before and after 8 weeks of study treatment | 8 week | |
Secondary | Improvment of blood cytokine levls | blood cytokine levls including IL-10, TNF, and IL 23 will be measured before and at the end of the study | 8 weeks | |
Secondary | Improvment of at least 30 points in quality of life as measured by the SF 36. | patients will answer a short form of Health related quality of life quasionnair before and at the end of the study. | 8 weeks |
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