Effects and Safety of Banhasasim-tang on Functional Dyspepsia

Not Applicable

Conditions: Diseases of the digestive system

Registration Number: KCT0002811

Lead Sponsor: Dunsan Korean Medicine Hospital of Daejeon University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Age from 19 yrs to 65 yrs of man or woman
2. Subjects who have normal opinion in endoscopy within 2 years
3. Subjects who meet the definition of ROME ? criteria (Criteria must be fulfilled for the past three months, with symptom onset at least six months before diagnosis)
? Presence of at least one of the following: bothersome postprandial fullness, early satiation, epigastric pain, epigastric burning
? No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms
4. Subjects who have at least two or more moderate symptoms among 8 symptoms of Nepean dyspepsia index Korean version (NDI-K); epigastric pain, epigastric discomfort, epigastric burning, epigastric stuffiness, epigastric fullness, postprandial fullness, early satiety, and have 6 points over or more total score from scoring of 8 symptoms (No symptom: 0, Mild: 1, Moderate: 2, Severe: 3)
5. Subjects who are referred with liver-stomach disharmony pattern functional dyspepsia using instrument of pattern identification for functional dyspepsia
6. Subjects who give voluntarily an written consent for the trial

Exclusion Criteria

1. Subjects who are not referred with liver-stomach disharmony pattern functional dyspepsia using instrument of pattern identification for functional dyspepsia
2. Subjects who have histories of gastrointestinal surgery (except appendectomy)
3. Subjects who have gastrointestinal bleeding, intestinal obstruction, gastrointestinal perforation
4. Subjects who have gastroduodenal ulcer, gastric cancer, colorectal cancer current or prior within 2 years
5. Subjects who require treatment for eradication of H.pylori or have been treated for eradication of H.pylori
6. Subjects who use corticosteroid drug, NSAIDs, prokinetic drug within 1 months prior to this study
7. Subjects who have liver tumor, liver cirrhosis, chronic renal failure, congestive heart failure
8. Hihg serum AST, ALT(> 2-fold of UNL) or hihg serum creatinine(> 1.2-fold of UNL)
9. Subjects who are in period of pregnancy or lactation, or planning to have a baby
10. Subjects who drink more than three times a week or often drink excessively.
11. Subjects who participated in other clinical trials for the last 3 months and took the drug
12. Subjects who are mentally unhelthy to follow the protocol properly