None listed
Conditions
Interventions
Drug : The study participants take 4g of Bangpungtongseong-san or 4g of Daeshiho-tang 3 times a day for 12 weeks.
Sponsors
Dongguk University Ilsan Oriental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Those who aged 19 to 65 (2) Those with BMI=27kg/m2, or with BMI=25kg/m2 and at least one of the risk factors for metabolic diseases such as high blood pressure, diabetes, and hyperlipidemia. - Hypertension: Those diagnosed with high blood pressure and receiving appropriate treatment, or those whose blood pressure measured during screening is over than 140 mmHg of sBP or over than 90 mmHg of dBP three consecutive times - Diabetes mellitus: Those diagnosed with diabetes mellitus and receiving appropriate treatment, or those with fasting glucose=126 mg/dL at the time of screening - Dyslipidemia: Those diagnosed with dyslipidemia and receiving appropriate treatment, or those whose total cholesterol (TC) measured during screening is over than 200 mg/dL or triglyceride (TG) is over than 200 mg/dL (3) Those who have not tried to lose weight in the last 1 month (4) Those who don’t meet the exclusion criteria and are generally in good health (5) Non-smoker (a person who has quit smoking for at least one year if he/she has smoked in the past) (6) Those who have not taken probiotics and antibiotics in the last 1 month (7) Those who have received sufficient explanation prior to participating in the test and have signed a written agreement approved by the IRB to participate in the study according to his/her free will.
Exclusion criteria
Exclusion criteria: (1) Those who have a change of more than 10% of his/her previous body weight within the last 3 months (2) Patients with endocrine diseases that may affect body weight such as hypothyroidism and Cushing’s syndrome (3) Patients with heart disease (heart failure, angina pectoris, myocardial infarction) (4) Patients with malignant tumor or lung disease (5) Patients diagnosed with liver dysfunction (ALT, AST = 2.5 times normal upper limit) (6) Patients with cholelithiasis (7) Patients diagnosed with severe renal failure (Cr > 2.0mg/dL) (8) Those who have taken probiotics and antibiotics in the last 1 month (9) Patients with a history of neurological or psychological significance or current illness (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, anorexia nervosa, etc.) or those on medication for the central nervous system (10) Patients with a history of stroke or temporary ischemic heart attack (11) Patients with history of basic eating disorders such as anorexia nervosa or bulimia nervosa (12) Patients who have taken medication that can affect weight, such as central weight loss agents, appetite suppressants, laxatives or oral steroids, thyroid hormones, amphetamines, ciproheptadine, phenodiazine or drugs that affect absorption, metabolism, and excretion within the last three months (13) Patients on medication that may be abused or receiving other prohibited treatments (antidepressant, antiserotonin, barbiturate, antipsychotics, drugs) (14) Patients with anatomical changes such as resection that are difficult to assess (15) Patients who have had surgery to lose weight: gastroplasty, etc. (16) Pregnant women, nursing mothers, women of childbearing potential who have plan for pregnant or who do not agree to the appropriate method of birth control (for example, oral contraceptives, hormonal transplants, IUDs, spermicide barrier methods, condoms, abstinence, etc.) (17) Those with a history of serious alcohol or drug abuse within the past 1 year (18) Those who are allergic to or overreacting to a clinical trial drug (19) Patients who have taken other test drugs within the last month (20) Those who are not willing or unable to comply with the living guidelines and precautions described in this plan (21) Those who are deemed inappropriate by the tester
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in weight change between each administration group | — |
Secondary
| Measure | Time frame |
|---|---|
| body composition (fat mass, muscle mass), waist circumference;body mass index (BMI) changes;Serum lipids (TG, TC, HDL-C) changes;Insulin and HOMA-IR changes;Dietary intake, Food intake Frequency;Korean obesity-related quality of life;gut microbial analysis;SNP analysis | — |
Countries
Korea, Republic of
Contacts
Public Contactwoojung Lim
Dongguk University Ilsan Oriental Hospital
Outcome results
None listed