Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis

Inclusion Criteria

• •1. Age ≥ 13 years and ≤ 75 years.
• •2. Mild, moderate and severe ulcerative colitis (biopsy-proven)
• •3. Mayo Scoring System Assessment of Ulcerative Colitis Activity score of 3 to 12 at screening.
• •4. Patients with active disease who are refractory to, intolerant to, or unwilling to take 5-aminosalicylic acid (5-ASA).
• •5. Patients of age ≥ 13 years and ≤ 17 years with active disease who are refractory or intolerant to 5-aminosalicyclic acid (5-ASA), corticosteroids, small molecule immunomodulators, and biologics or corticosteroid-dependent.
• •6. Physician's Global Assessment (PGA) Mayo subscore of at least 1 at screening.
• •7. Endoscopic evidence of active mucosal disease as assessed by flexible sigmoidoscopy with Mayo mucosal appearance subscore of at least 1 at screening.
• •8. Female patients of child-bearing potential must have a negative serum pregnancy test at the screening visit and agree to use two medically reliable methods of contraception (such as barrier with either spermicide or hormonal contraception) during the study period.
• •9. Male patients must be willing to use acceptable contraceptive methods and assure that their female partners of child-bearing potential use acceptable contraceptive methods during the study period.
• •10. Ability to adhere to the study visit schedule and other protocol requirements.
• •11. Adequate cardiac, renal, and hepatic function as determined by the principal investigators.
• •12. Written informed consent will be obtained before any study procedure is performed.