Study with the herbal preparation STW5-II in patients with mild to moderate ulcerative colitis (chronic inflammatory bowel disease)

• Conditions: lcerative colitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-000891-13-DE
• Lead Sponsor: Steigerwald Arzneimittelwerk GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-24
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Patients with confirmed ulcerative colitis (UC) by symptoms, endoscopy and histology
- Patients with mild to moderate active ulcerative colitis (UC), i.e. 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 but not more than 28 days before Visit 2
-Age between 18 to 80 years (including)
-UC may reach from left-sided colitis to pancolitis
-Willing and able to understand and sign an approved Informed Consent form.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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
-Topical mesalazin application
-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
-Anticoagulant medication
-Any condition or concomitant therapy that in the opinion of the investigator may jeopardize the patients well-being
-Total colectomy
-Known allergies to components of STW5-II
-Severe allergic diathesis
-History of current or past alcohol or drug abuse
-Known intolerance to azo dyes E110 und E151
-Severe comorbidity
-Consumption of any investigational product within one month prior to the screening visit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified