Evaluation of the efficacy of Thymus kotschyanus extract as an additive treatment in patients with ulcerative colitis: a randomized double-blind placebo-controlled trial.

Background: Ulcerative colitis (UC) is one of the chronic diseases which is increasing in prevalence and patients suffer from illness flare-ups. UC standard regimen treatment has various side effects besides the efficacy, so there is an interest in administering complementary medicine to reduce adverse effects and increase the efficacy, as well. The aim of this study was to evaluate the efficacy and anti-inflammatory effect of Thymus kotschyanus as an additive treatment in a randomized double-blind placebo-controlled trial of UC patients.

Methods: Thirty UC out-patients with mesalazine regimen treatment that fulfilled the inclusion criteria were participated in a 12 week trial and were randomly chosen for the treatment and control group. Fifteen patients were administered a placebo as a control and 15 patients were received Thymus kotschyanus extract by a dose of 0.5 g in a day in the treatment group. Laboratory tests were performed at baseline and week 12. The primary outcome was a reduction in fecal calprotectin as the main intestine inflammatory marker. Likewise, reduction in SCCAI, SIDBQ, and SEO indices were considered as secondary aims.

Results: Fecal calprotectin was decreased by 54.74% in the treatment group, as compared with the placebo group at week 12 (p = 0.02). A significant reduction in SCCAI was also shown between the two study groups (p = 0.01). Thymus kotschyanus extract was safe and no severe side effects were reported.

Conclusion: Administration of Thymus kotschyanus revealed improvement in UC symptoms by the intestinal anti-inflammation effect of the plant and could be suggested as a potential additive treatment in UC patients. The study protocol has been registered under the identification code: IRCT20200406046965N2.