Trial Details

Recruiting
Basic Information
Clinical ID c5367
Identifier CTRI/2022/10/046658
Trial Title A Phase II, Multicenter, Randomized, Double-blind, Placebo controlled Clinical study to evaluate efficacy and safety of PNB-001 as an adjunct to Mesalamine compared to Mesalamine alone in Subjects with Inflammatory bowel disease
Trial URL Visit Original Page
Study Information
Study Results

NULL
Conditions Health Condition 1: K509- Crohns disease, unspecified Health Condition 2: K519- Ulcerative colitis, unspecified
Interventions Intervention1: PNB001 50 mg: One capsule three times daily with water after meals with the stable dose of oral Mesalamine of at least 2.4 gm/day for 4 weeksIntervention2: PNB001 100mg: One capsule three times daily with water after meals with the stab
Participant Information
Sponsor PNB Vesper Life Science Pvt Ltd
City NULL
Country/Region India
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement NULL
Study Design
Study Type Interventional
Phase PHASE2
Time Information
Start Date NULL
Primary Completion Date NULL
Completion Date NULL