ulcerative colitis.
Conditions
Interventions
Intervention 1: cap corchomin 80 mg twice a day for three months. Intervention 2: Placebo cap twice daily.
Treatment - Drugs
Placebo
cap corchomin 80 mg twice a day for three months
Placebo cap twice daily
Sponsors
EXIR nano sina
Tehran university 0f medical science
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: It’s a randomized double blind controlled trial in patients with mild to moderate ulcerative colitis which is under treatment with maximum dose of mesalamine. Patients aged between 18-70 years old with UC, which has been approved by endoscopy, will be enrolled. Mild to moderate active UC based on “simple clinical colitisactivity index (SCCAI) score” will be defined as <5 and <12 score, respectively. subjects with history of current or in past 12 weeks use of steroids, taking anti-TNF or cyclosporine, has Hgb<10 mg/dl or hematologic abnormalities including leukopenia, thrombocytopenia, those with impaired renal, coagulation or liver tests, subjects with positive C diff infection, pregnant patients, presence of active sepsis and nurses will be excluded from the study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Simple clinical colitisactivity index (SCCAI) score. Timepoint: At the begining of study, 8 week after treatment. Method of measurement: questionairre.;Stool calprotectin. Timepoint: At the begining of study, 8 week after treatment. Method of measurement: lab test.;Mayo score. Timepoint: at the begining of study, 8 week after treatment. Method of measurement: questionairre.;Serum cytokins(IFN-?, IL- 12, IL-4, IL-10, TGF-ß , IL-17). Timepoint: At the begining of study, 8 week after treatment. Method of measurement: lab test.;Grading scale for histological assessment of inflamation in ulcerative colitis. Timepoint: at the begining of study, 8 week after treatment. Method of measurement: biopsy and lab test.;Self assessment scales for evaluating mood chracteristcs pre and post intervention. Timepoint: at the begining of study, 8 week after treatment. Method of measurement: questionairre.;CRP. Timepoint: at the begining of study, 8 week after treatment. Method of measurement: lab test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hgb. Timepoint: At onset of study, end of study (8 week after treatment). Method of measurement: lab test.;Quantity of Bacteroidous family and colestridium. Timepoint: At onset of study, end of study (8 week after treatment). Method of measurement: lab test. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehdi Moosavian
Tehran university of medical science
Outcome results
None listed