Evaluation of the effect of Thymus kotschyanus Boiss. & Hohen. in improving ulcerative colitis symptoms

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

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

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.