ulcerative colitis. Ulcerative colitis
Conditions
Interventions
Intervention 1: Intervention group: consisted of 15 patients who were randomized by computer took one extraction capsule three times a day by the effective daily dose 0.5 grams of T. kotschyanus besid
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
13 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients who were diagnosed by ulcerative colitis and not been hospitalized during this clinical trial Patients must be between 13 and 65 years' old The Simple Clinical Colitis Activity Index (SCCAI) score must be higher than 5 and less than 13 Patients must have taken mesalazine with fixed dose since at least 1 month ago and not exceed more than 4.5 grams mesalazine in a day If patients have administered topical mesalazine it should be used at least for 2 weeks with a fixed dose and not exceed more than 4 grams in a day Patients shouldn’t have taken another anti-inflammatory or immunomodulatory medicine except mesalazine Hemoglobin must be higher than 10 No concurrent disease such as diabetes, cardiovascular disease, kidney disease, liver disease, thyroid disease, bile disease No concurrent leukopenia, thrombocytopenia or other blood coagulation disorders No concurrent sepsis or any active infection No pregnancy or breast feeding No taking any anti-coagulant medicine No history for epilepsy or convulsions
Exclusion criteria
Exclusion criteria: Acute severe ulcerative colitis requiring hospital admission (SCCAI >13); inactive disease (SCCAI < 3). A history of sensitivity to Thymus kotschyanus or its preparations. A history of diabetes, cardiovascular diseases, kidney disease, liver diseases, thyroid disease, bile disease and leukopenia, thrombocytopenia. Hemoglobin less than 10. Pregnancy. Reluctance to continue this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in SCCAI score. Timepoint: 12 weeks after intervention beginning. Method of measurement: Filling the questionnaire for SCCAI score .;Reduction in calprotectin protein. Timepoint: 12 weeks after intervention beginning. Method of measurement: Measuring the laboratory test for fecal calprotectin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission and improvement changes in SIBDQ scores. Timepoint: 12 weeks after intervention beginning. Method of measurement: Filling the SIBDQ questionnaire.;Reduction in SEO index. Timepoint: 12 weeks after intervention beginning. Method of measurement: Measuring the related laboratory test for SEO index.;Finding T. kotschyanus possible adverse effects. Timepoint: Week 4 and 8 and 12 after intervention beginning. Method of measurement: Asking patients about any adverse reaction incidence. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyed Ahmad Emami
Mashhad University of Medical Sciences
Outcome results
None listed