This study is designed to investigate the objective effects of Hyangsapyeongwisan on functional dyspepsia
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0000066
- Lead Sponsor
- Korea Health Industry Development Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 170
The inclusion criteria for this study were as follows;
? All men and women aged between 20 and 70 years
? All of the patients who meet the definition of the Rome ?
? Patients with more than 2 moderate symptoms of epigastric pain, epigastric discomfort, epigastric burning, early satiety, postprandial fullness, epigastric pressure sense, epigastric bloating and nausea, and a total score or higher based on the following scale for each symptom:
? 0 absence of the symptom.
? 1 mild symptom: patients feel the symptoms during the medical examination of physicians but no treatment is required.
? 2 moderate symptom: patients feel the symptoms but they seldom interfere with normal daily activities
? 3 severe symptom: patients feel the symptoms interfere with normal daily activities
Patients who report the following conditions will be excluded;
? History of gastrointestinal surgery (except, appendectomy)
? Patients at risk from gastrointestinal motility for reasons such as gastrointestinal bleeding, mechanical obstruction, or perforation
? The presence of a disease causing different results in the evaluation of the digestive system within the past two years
? Ingestion of drugs that affect the results of the research drug
? Liver cancer or cirrhosis, chronic renal failure, congestive heart failure
? Women who are pregnant, lactating, or who are of childbearing age and do not use an appropriate contraceptive method.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The changes of total score of before and after the trial on the 8 symptoms high correlate with dyspepsia at the NDI score of symptoms
- Secondary Outcome Measures
Name Time Method The changes of NDI 15 symptom score before and after the trial;The changes of NDI 15 symptom total score of before and after the trial;The changes of quality of life score by domains of NDI before and after the trial;The changes of quality of life total score of NDI before and after the trial;The changes of quality of life total score of FD-QOL before and after the trial;The changes of quality of life of FD-QOL score by domains before and after the trial;Symptom improvement rate: According to decreasing total score of primary endpoint NDI 8 dyspeptic symptoms