Evaluation of Clinical Use by Comparative Efficacy and Safety Study of Fine Granvles for Upper Gastrointestinal Disorders Including Symptoms

상부 소화관 질환증상에 대한 제산.소화효소제와 생약제를 함유한 복합제제 세립의 유용성

The purpose of this study was to evaluate the clinical efficacy and safety of NRM which was newly developed as a combination product containing antacids, digestive enzyme and herbal drugs, and OTA powder, called OHTA'S ISAN on the morret, for the treatment of various symptoms in upper gastrointestinal diseases. 63 patients were recruited, 36 as a treated group with NRM and 27 as a controlled one with OTA. Patients were randomly allocated to receive either NRM or OTA t.i.d. for treatment of upper G-1 symptoms and undergone endoscopic, symptomatic and clinical laboratory assessments before and after 2 weeks. The results were as follows; 1. The general improvement rates of subjective symptoms in upper G-1 diseases were observed in 100%(32/32) for NRM and in 92%(23/25) for OTA. 2. The overall effective rates in terms of the symptoms and endoscopic findings were 88.9%(32/36) for NRM and 85.2%(23/27) ,or OTA respectively. 3. In NRM group, no significant side effects by NRM were observed except a mild and transient vomiting in one patient, but in OTA group treatment was discontinued due to nousea in one patient, However, there were no clinically significant changes detected in the laboratory parameters. According to the result of this trial, it is cocluded that NRM was safe and effective and (but not statistically significant) was superior to OTA in the treatment of gastrointestinal diseases caused by gastritis, gastric and duodenal ulcer, functional gastrointestinal disorder, non-ulcer dyspepsia etc.