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 -

• Status: Completed
• Trial end date: 2020-12-02
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gachon University Gil Oriental Medical Hospital
• Collaborators: DongGuk University; Dongguk University Ilsan Oriental Hospital; Sangji University Oriental Medical Hospital, Korea

Criteria

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