Objectives of Study:
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In our previous study, Jia Wei Dachaihu Tang (JWDT) has been proved reliable in pharmacodynamics and be an effective TCM prescription for overweight and obesity. This study will be conducted to further verify the therapeutic effect of Jia Wei Dachaihu Tang in weight or obesity, and investigate its impact on insulin resistance, food intake, emotion, gut microbiota, inflammation, etc, what's more, pursue the possible mechanism how Jia Wei Dachaihu Tang targets overweight and obesity from the perspective of gut microbiota.
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Exclusion criteria:
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1.Patients with the endocrine disease that may affect body weight, such as hypothyroidism, Cushing's syndrome, or those with thyroid-stimulating hormone concentration < 0.1 uIU/ml or > 10.0 uIU/ml.
2.Subjects who are already on a diet or undertaking heavy exercise for weight control purposes.
3.Subjects who have undergone surgical procedures for weight control.
4.Patients with a history of neurological or psychological disease or currently suffering from such diseases (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia, etc.)
5.Patients with a history or existence of eating disorders such as anorexia nervosa or bulimia nervosa, etc.
6.Patients with experience of medications that could have an effect on weight within last 3 months such as appetite suppressant, laxative, or oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine, or medications affecting absorption, metabolism, and excretion.
7.Subjects who diagnosed with diabetes or other metabolic health disturbances.
8.Patients who have used other clinical trial drugs within 3 months.
9.Subjects who have had weight changes > 10% of their previous weight within the last 6 months.
10.Those whose aspartate transaminase or alanine transaminase exceeds five times the normal upper limit (200 IU/L).
11.Kidney dialysis patients or those with creatinine concentration more than twice the normal upper limit.
12.Those who are in seriously unstable medical condition, such as cardiovascular disease, respiratory disease, gastrointestinal disease, hepatobiliary disease, metabolic disease, endocrine disease, renal disease, or problems in the urinary reproductive system and nervous system.
13.Those who have had a diagnosis or have been treated for malignant tumors within the last 5 years.
14.Women who are pregnant, planning to become 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.).
15.Receiving medications or supplements that could affect gut microbiota during the last 3 months(examples: antibiotics, probiotics, prebiotics, laxatives, etc.).
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