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 4

Completed

• Conditions: Metabolic Syndrome; Obesity
• Interventions: Drug: Chowiseungcheng-tang; Drug: Daesiho-tang; Drug: Placebo

• Registration Number: NCT02651454
• Lead Sponsor: Gachon University Gil Oriental Medical Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-31
• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-11
• Primary Completion: 2020-05-02
• Study Completion: 2020-12-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-09
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jowiseungcheung-tang	Chowiseungcheng-tang	Dose: 6g, three times a day, each taken before or between meals for 12 weeks
Daesiho-tang	Daesiho-tang	Dose: 6g, three times a day, each taken before or between meals for 12 weeks
Placebo	Placebo	Dose: 6g, three times a day, each taken before or between meals for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes from baseline in body weight	baseline, 12 weeks

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in C-reactive protein (CRP)	Screening visit, 12 weeks
Changes from baseline in abdominal visceral fat area	baseline, 12 weeks
Korean version of Eating Attitudes Test-26	baseline, 12 weeks
Changes from baseline in fat mass	baseline, 4,8,12,16 weeks
Changes from baseline in Waist/hip ratio	baseline, 4,8,12,16 weeks
Changes from baseline in body fat percentage	baseline, 4,8,12,16 weeks
Changes from baseline in Waist circumference	baseline, 4,8,12,16 weeks
Changes from baseline in Body mass index	baseline, 4,8,12,16 weeks
Changes from baseline in Lipid profile	Screening visit, 12 weeks
Korean Obesity-related Quality of Life (QoL) scale	baseline, 12 weeks
Changes from baseline in blood glucose	Screening visit, 12 weeks

Trial Locations

Locations (1)

Gachon University Gil Oriental Medical Hospital; 🇰🇷 Incheon, Korea, Republic of