Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients

A Randomised, Double-blind, Placebo-controlled Multi-centre Study to Investigate the Effectiveness and Safety of STW5-II as add-on Treatment for Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis

The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in patients with mild to moderate ulcerative colitis in an acute flare.

Inclusion Criteria:

• Patients with mild to moderate active ulcerative colitis (UC), i.e. Clinical Activity Index (CAI) ≥ 5 up to 10 points (including)
• Patients in whom the active UC is treated independent from any participation in the current study with oral mesalazine at least 14 days up to maximal 28 days before Visit 2
• Age between 18 to 80 years (including)
• UC may reach from left-sided colitis to pancolitis

Exclusion Criteria:

• Severe forms of UC (CAI > 10)
• Crohn's disease, infectious colitis or undetermined colitis
• Steroid dependence and steroid resistance
• Concomitant medication with oral steroids, oral or topic budesonide, biologicals, immune modifiers, immunosuppressants
• Antibiotics at screening visit, during the course of the study a short-term use in non-colitic afflictions is allowed, and is documented
• Prior medication with biologicals, immune modifiers and immunosuppressants < 3 month wash-out
• Total colectomy
• Known allergies to components of STW5-II
• Severe allergic diathesis
• Topical mesalazine application
• Known intolerance to azo dyes E110 and E151