Evaluation of Oral Nano-Curcumin Formulation Effectiveness in Patients With Mild to Moderate Ulcerative Colitis: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial Publisher



N Ebrahimidaryani NASSER ; M Alebouyeh MASOUD ; E Tajeddin ELAHE ; S Nazarbeigi SAEED ; Mr Jaafari Mahmood REZA ; S Elyasi SEPIDEH ; H Karbasforooshan HEDYIEH ; S Akhondzadeh SHAHIN ; A Abdollahi ALIREZA ; N Aletaha NAJME
Source: Naunyn-Schmiedeberg's Archives of Pharmacology Published:2025

Abstract

Recent clinical trials have exhibited that curcumin, a natural polyphenolic compound, is effective as adjuvant therapy in patients with ulcerative colitis (UC). In this randomized, placebo-controlled, double-blind study, 43 patients with mild-moderate UC who were referred to the gastrointestinal ward of Imam Khomeini Hospital in Tehran, Iran were assessed. They were randomly specified to the intervention (n = 21, SinaCurcumin® soft gel 80 mg) or the placebo (n = 22) group, administered twice a day for 1 month, in addition to 5-aminosalicylic acid. The main consequence of the study was to get to a decrement of at least three scores in the Simple Clinical Colitis Activity Index (SCCAI) within a month. Endoscopic and histopathological responses and Hospital Anxiety and Depression Scale (HADS) score changes were also recorded. The clinical (p = 0.031, χ2 = 4.66) and endoscopic (p = 0.005, χ2 = 8.55) responses and also HADS score changes (p = 0.06, t = − 1.35) were significantly higher in the treatment group. No significant diversity was presented between groups in terms of inflammatory markers and total anti-oxidant capacity and fecal calprotectin level (p value > 0.05). Nano-curcumin oral formulation with a dose of 80 mg twice daily for 1 month in patients with mild to moderate UC could be an effective adjunct to 5-aminosalicylic acid in clinical, endoscopic, and histopathological response. © 2025 Elsevier B.V., All rights reserved.