Cannabis for Inflammatory Bowel Disease
Raktažodžiai
Santrauka
Datos
Paskutinį kartą patikrinta: | 11/30/2011 |
Pirmasis pateikimas: | 12/28/2009 |
Numatytas registravimas pateiktas: | 12/28/2009 |
Pirmas paskelbtas: | 12/29/2009 |
Paskutinis atnaujinimas pateiktas: | 12/14/2011 |
Paskutinis atnaujinimas paskelbtas: | 12/15/2011 |
Faktinė studijų pradžios data: | 12/31/2009 |
Numatoma pirminio užbaigimo data: | 05/31/2012 |
Numatoma studijų užbaigimo data: | 06/30/2012 |
Būklė ar liga
Intervencija / gydymas
Drug: cannabis smoking for IBD
Drug: patients smoking non active cannabis
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
Active Comparator: cannabis smoking for IBD patients with active disease receiving active cannabis for smoking | Drug: cannabis smoking for IBD smoking of cannabis, 2 cigarettes a day, equivalent to about 50 mg THC |
Placebo Comparator: patients smoking non active cannabis patients with active disease receiving cannabis from which active ingredients have been chemically removed | Drug: patients smoking non active cannabis smoking cigarettes with cannabis that was chemically treated so that most active ingredients were removed |
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 20 Years Į 20 Years |
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria: 1. Patients with a diagnosis IBD at least 3 months before recruitment will be eligible to the study. 2. Patients with active disease who are resistant to either 5 ASA, steroids or immunomodulators, or who can not receive those drugs due to adverse reactions will be offered the possibility of smoking cannabis at a dose of two cigarettes a day which will contain either regular cannabis or pre treated cannabis as placebo. 3. Disease activity index of either CDAI of more then 200 in Crohn's disease or Mayo score above 3 in UC. 4. Age above 20. Exclusion Criteria: 1. Patients with a known mental disorder 2. Patients who are deemed to be at a high risk of abuse or addiction to the study drug. 3. Pregnant women 4. Patients who are sensitive to any of the ingredients of the study medication. 5. Patients who are unable to give informed consent. 6. Patients who may need surgery in the near future. |
Rezultatas
Pirminės rezultatų priemonės
1. reduction of CDAI by 70 points [8 weeks]
Antrinės rezultatų priemonės
1. adverse events due to cannabis smoking [8 weeks]
2. change in quality of life before and at the end of study [8 weeks]
3. change in IL-10. IL-2. TGF beta [week 0 and week 8]