Effect of TU-100 in Patients With Functional Constipation

Exclusion Criteria

• •1. Presence of strictures, fistulas, or physiological or mechanical bowel obstruction.
• •2. Presence of implanted or portable electro-mechanical medical devices.
• •3. History of gastric bezoar or swallowing disorders.
• •4. History of gastrointestinal surgery within 3 months of screening.
• •5. History of bowel resection.
• •6. Current pregnancy or lactation.
• •7. History of clinically significant alcohol or drug abuse within a year of screening.
• •8. Have any other condition that might adversely affect capacity to participate in this study, including liver disorders (with serum alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] levels exceeding 2.5 times the upper limit of normal \[ULN\]), kidney disorders, heart failure, blood disorders, or metabolic disorders.
• •9. Be diagnosed with cancer, ulcerative colitis, Crohn's disease, diverticulitis, scleroderma, Hirschsprung's disease, Chagas' disease, multiple sclerosis, Parkinson's disease, stroke, paraplegia, quadriplegia, insulin-dependent diabetes mellitus, untreated hypothyroidism, or any other systemic or psychiatric disorder which may, in the opinion of the investigator, interfere with the evaluation of TU-100.
• •10. Be taking any medication as follows: anticholinergic agents/medications with anticholinergic effect (list of prohibited drugs attached in Appendix G; antidepressants are permissible if the patient's symptoms are stable, and the doses are NOT changed during the course of the study), warfarin, prokinetics (i.e., Domperidone, Metoclopramide), narcotic analgesics, or any agent that might interfere with the evaluation of TU-100 in the opinion of the investigator.
• •11. Have a history of allergic reaction or hypersensitivity to ginseng, ginger, and Sichuan pepper.
• •12. Have severe dysphagia to food or pills.
• •13. Have participated in any other clinical study within 30 days before enrolling in this study.
• •14. Be unsuitable for participation in this trial for any reason, according to the investigator.