A Pilot Study Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With Metabolic Syndrome Risk Factors - Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial -

Gachon University Gil Oriental Medical Hospital

Status and phase: Completed; Phase 4

Conditions: Obesity; Metabolic Syndrome

Treatments: Drug: Chowiseungcheng-tang; Drug: Placebo; Drug: Daesiho-tang

Study type: Interventional

Funder types: Other

Identifiers

NCT02651454

ISEE_2015_OBESITY

Details and patient eligibility

About

The Purpose of this trial is to investigate the efficacy and safety of Daesiho-tang and Taeeumjowi-tang on Korean obese Women with metabolic syndrome Risk factors

Enrollment: 120 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female aged 18 to 65 years

• Subject must included at least one or more of the following symptoms below

  • BMI of 30 kg/㎡ or more;
  • BMI between 25 and 29.9kg/㎡ with hypertension, taking medication or SBP ≥ 140mmHg or DBP ≥ 90mmHg at the screening visit
  • BMI between 25 and 29.9kg/㎡ with non-insulin-dependent diabetes mellitus, taking medication or fasting blood glucose > 126mg/dL at the screening visit
  • BMI between 25 and 29.9kg/㎡ with hyperlipidemia, taking medication or total cholesterol ≥ 200mg/dL or Triglyceride ≥ 150mg/dL at screening visit

• Agreed to low-calorie diet during the trial

• Written informed consent of the trial

Exclusion criteria

• Endocrine diseases associated with weight gain, such as hypothyroidism, Cushing's syndrome, etc.
• Heart disease (heart failure, angina pectoris, myocardial infarction)
• Cholelithiasis
• Severe renal disability (SCr > 2.0 mg/dL)
• Severe liver disability (2.5 fold of normal high range value on Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], alkaline phosphatase)
• History of narrow angle glaucoma
• History of stroke or temporary ischemic cardioplegia
• History of eating disorder such as anorexia nervosa or bulimia nervosa, etc.
• Use of medication that can affect on weight within last 3 months (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medications can affect on absorption, metabolism, excretion)
• Use of CNS stimulant medication for weight loss
• Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse)
• history of weight loss surgery, such as bariatric surgery, etc.
• Subjects who are judged to be inappropriate for the clinical study by the researchers
• Women who were pregnant, lactating or have the chances of pregnancy who do not agree to proper contraception (birth-control pill, hormone implant, IUD, spermicide, condom, abstinence, etc.)
• Use of other investigational product within last 1 month
• 10 percent reduction in body weight over 6 months
• Decided to quit smoking over the last 3 months or have irregular smoking habits

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Daesiho-tang

Experimental group

Description:

Dose: 6g, three times a day, each taken before or between meals for 12 weeks

Treatment:

Drug: Daesiho-tang

Jowiseungcheung-tang

Experimental group

Description:

Dose: 6g, three times a day, each taken before or between meals for 12 weeks

Treatment:

Drug: Chowiseungcheng-tang

Placebo

Placebo Comparator group

Description:

Dose: 6g, three times a day, each taken before or between meals for 12 weeks

Treatment:

Drug: Placebo