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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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ClinicalTrials.gov Identifier: NCT02651454
Recruitment Status : Recruiting
First Posted : January 11, 2016
Last Update Posted : February 11, 2019
Sponsor:
Collaborators:
Sangji University Oriental Medical Hospital, Korea
DongGuk University
Information provided by (Responsible Party):
Yun-Kyung Song, Gachon University Gil Oriental Medical Hospital

Tracking Information
First Submitted Date  ICMJE January 5, 2016
First Posted Date  ICMJE January 11, 2016
Last Update Posted Date February 11, 2019
Actual Study Start Date  ICMJE December 31, 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
Changes from baseline in body weight [ Time Frame: baseline, 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02651454 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
  • Changes from baseline in body fat percentage [ Time Frame: baseline, 4,8,12,16 weeks ]
  • Changes from baseline in fat mass [ Time Frame: baseline, 4,8,12,16 weeks ]
  • Changes from baseline in Waist circumference [ Time Frame: baseline, 4,8,12,16 weeks ]
  • Changes from baseline in Waist/hip ratio [ Time Frame: baseline, 4,8,12,16 weeks ]
  • Changes from baseline in Body mass index [ Time Frame: baseline, 4,8,12,16 weeks ]
  • Changes from baseline in Lipid profile [ Time Frame: Screening visit, 12 weeks ]
  • Changes from baseline in C-reactive protein (CRP) [ Time Frame: Screening visit, 12 weeks ]
  • Changes from baseline in blood glucose [ Time Frame: Screening visit, 12 weeks ]
  • Changes from baseline in abdominal visceral fat area [ Time Frame: baseline, 12 weeks ]
  • Korean Obesity-related Quality of Life (QoL) scale [ Time Frame: baseline, 12 weeks ]
  • Korean version of Eating Attitudes Test-26 [ Time Frame: baseline, 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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 -
Official Title  ICMJE 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 -
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Metabolic Syndrome
  • Obesity
Intervention  ICMJE
  • 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:
    • DST
    • Elsion Granule
  • Drug: Jowiseungcheung-tang
    Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: Hanzung Pharmaceutical. co. Ltd.
    Other Name: JWSCT
  • Drug: Placebo
    Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Study Arms  ICMJE
  • Experimental: Daesiho-tang
    Dose: 6g, three times a day, each taken before or between meals for 12 weeks
    Intervention: Drug: Daesiho-tang
  • Experimental: Jowiseungcheung-tang
    Dose: 6g, three times a day, each taken before or between meals for 12 weeks
    Intervention: Drug: Jowiseungcheung-tang
  • Placebo Comparator: Placebo
    Dose: 6g, three times a day, each taken before or between meals for 12 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Youme Ko, MD(TCM) 8229619278 meyougo@khu.ac.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02651454
Other Study ID Numbers  ICMJE ISEE_2015_OBESITY
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yun-Kyung Song, Gachon University Gil Oriental Medical Hospital
Study Sponsor  ICMJE Gachon University Gil Oriental Medical Hospital
Collaborators  ICMJE
  • Sangji University Oriental Medical Hospital, Korea
  • DongGuk University
Investigators  ICMJE
Principal Investigator: Yun-Kyung Song, KMD Gachon University Gil Oriental Medical Hospital
PRS Account Gachon University Gil Oriental Medical Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP