Trial | NCT02651454  Report issue

Official Title

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 -

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    120
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
Study Started
Dec 31
2015
Primary Completion
May 02
2020
Study Completion
Dec 02
2020
Last Update
Apr 12
2021

Drug Daesiho-tang

Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.

  • Other names: DSHT, Elsion Granule

Drug Chowiseungcheng-tang

Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: Hanzung Pharmaceutical. co. Ltd.

  • Other names: CST

Drug Placebo

Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.

Daesiho-tang Experimental

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

Jowiseungcheung-tang Experimental

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

Placebo Placebo Comparator

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

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
No Results Posted