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 -

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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