The Clinical Study on the Effect of Hyangsayukgunja-tang on the Spleen Qi deficiency
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0001428
- Lead Sponsor
- Kyung Hee University Oriental Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Age over 18 and under 65
- BMI < 23kg/m2
- Having symptoms of fatigue, anorexia, decreased amount of food, and diagnosed as the Spleen Qi deficiency by the score of Spleen Qi Deficiency Questionnaire (SQDQ) over 48.86
- Subjects who give written informed consents
- Diabetes mellitus(Having past history or fast blood sugar over 126?/? at screening test), History of liver disease(hepatitis, hepatocirrhosis) or abnormality of liver function(AST or ALT over 60U/L at screening), abnormality of renal function(Creatinine over 1.2 ?/? at screening), heart disease(heart failure, angina, heart failure, arrhythmia), history of cancer
- Possibility of anorexia nervosa, bulimia nervosa, or other similar disorders (applicants satisfying the DSM-IV criteria for eating disorder and those who scored =88 in the Bulimia Test Revised or =21 in the Korean Version of Eating Attitude Test-26 were eliminated)
- Drinking alcohol more than three times a week in recent three months
- Change of body weight more than 5% of the present weight in recent three months
- Having irregular meal pattern(Not eating breakfast, eating breakfast before 6am or after 10am more than three times a week)
- Attending different clinical trial
- During pregnancy or breast-feeding, or having plan of pregnacy, or disagreement of proper contraception in fertile women
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes of the total scores of Spleen Qi Deficiency Questionnaire (SQDQ) from the baseline to the week 4
- Secondary Outcome Measures
Name Time Method