A study of Daesiho-tang on weight loss in Obese Patients with non-alcoholic fatty liver disease

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

(1) Adults over 19 years to under 65 years
(2) Obese subjects with body mass index =25 kg/m2
(3) Subjects with non-alcoholic fatty liver findings on Fibroscan analysis: CAP (Controlled Attenuation Parameter) score over 268 dB/m
(4) Those who have voluntarily signed written consent approved by IRB, after sufficient explanation of this study

Exclusion Criteria

(1) Subjects who have had weight changes more than 10% of their previous weight within the last 6 months
(2) Subjects who are already on diet or heavy exercise for weight control purposes
(3) Subjects who had undergone surgical procedures (such as gastroplasty) for weight control
(4) Patients with endocrine disease that may affect body weight, such as hypothyroidism, Cushing's syndrome, or those with TSH concentration less than 0.1 uU/ml or more than 10.0 uU/ml
(5) Patients with evidence of chronic hepatitis, such as hepatitis B, hepatitis C, autoimmune hepatitis, and metabolic hepatitis (HBsAg or HCV Ab positive in screening tests)
(6) Subjects with alcohol intake over 210 grams per week for men and over 140 grams for women during the last year
(7) Liver Stiffness Measurement (LSM) of 12.5 kPa or higher on FibroScan test
(8) Subjects who have received liver transplants
(9) Subjects who use insulin injections to control blood glucose concentration
(10) Subjects taking thiazolidinediones and high-dose vitamin E that may affect non-alcoholic fatty liver disease
(11) Those who had taken drugs that can be used to treat obesity (absorption inhibitors and appetite suppressants), antidepressants, contraceptives, oral steroids, amphetamines, phenodiazines, ciproheptadins, female hormones or thyroid hormones within 3 months of screening
(12) Those whose AST or ALT exceeds 5 times the normal upper limit (200 IU/L)
(13) Kidney dialysis patients or those with creatinine concentration more than twice the normal upper limit
(14) Those who are in seriously unstable medical conditions such as cardiovascular disease, respiratory disease, gastrointestinal disease, hepatobiliary disease, metabolic disease, endocrine disease, renal disease or problems in urinary reproductive system and nervous system
(15) Those who have had diagnosed or have been treated for malignant tumors within the last 5 years
(16) Women who are pregnant or lactating, or subjects who do not agree to use effective methods of contraception during the clinical trial (Oral contraceptives are not allowed during the clinical trial)
(17) Subjects with genetic problems, such as galactose intolerance, Lapp lactase deficiency, or glucose-galatose malabsroption
(18) Subjects with a history of alcohol abuse or drug abuse within the past year
(19) Subjects who had taken other clinical trial drugs within 3 months
(20) Subjects who are thought to be inappropriate for this study

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body weight

Secondary Outcome Measures

Name	Time	Method
Body composition analysis (fat percentage, fat mass, muscle mass);anthropometric measurements (waist circumference, hip circumference);AST, ALT, gamma-GT;serum lipid concentrations;Fibroscan analysis (CAP score and LSM score);Quality of Life questionnaire;Intestinal microbial composition