Effects and Safety of Banhasasim-tang on Functional Dyspepsia

Effects and Safety of Banhasasim-tang on Functional Dyspepsia : A Randomized, Double-blind, Placebo-controlled, Pilot Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002013

Enrollment

Registered

2016-08-18

Start date

2016-08-12

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : BST or placebo oral administration for 4 weeks. BST or placebo 10g twice a day, total 20g per day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age from 19 yrs to 75 yrs of man or woman 2. Subjects who have normal opinion in endoscopy within 3 years 3. Subjects who meet the definition of ROME ? criteria 4. Subjects who have at least two or more moderate symptoms among 8 symptoms; 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 excess pattern functional dyspepsia using instrument of pattern identification for functional dyspepsia 6. Subjects who give voluntarily an written consent for the trial

Exclusion criteria

Exclusion criteria: 1. Subjects who are not referred with excess 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 use corticosteroid drug, NSAIDs, prokinetic drug within 1 months prior to this study. 6. Subjects who have liver tumor, liver cirrhosis, chronic renal failure, congestive heart failure 7. Hihg serum AST, ALT(> 2-fold of UNL) or hihg serum creatinine(> 1.2-fold of UNL) 8. Subjects who are in period of pregnancy or lactation, or planning to have a baby 9. Subjects who are mentally unhelthy to follow the protocol properly.

Design outcomes

Primary

Measure	Time frame
Nepean dyspepsia index Korean version symptome score	—

Secondary

Measure	Time frame
Nepean dyspepsia index Korean version QoL score;Functional Dyspepsia Quality of Life(FD-QoL) score;Visual Analogue Scale(VAS);Power ratio of electrogastrography;Electrogastrography	—

Countries

Korea, Republic of

Contacts

Public ContactJun-Young Kim

Daejeon Korean Medicine Hospital of Daejeon University

jy-057@daum.net

Outcome results