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Trial record 10 of 95 for:    body | Recruiting, Not yet recruiting, Available Studies | "Metabolic Syndrome X"

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

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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Obesity Drug: Daesiho-tang Drug: Jowiseungcheung-tang Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 -
Actual Study Start Date : December 31, 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Daesiho-tang
Dose: 6g, three times a day, each taken before or between meals for 12 weeks
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

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

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




Primary Outcome Measures :
  1. Changes from baseline in body weight [ Time Frame: baseline, 12 weeks ]

Secondary Outcome Measures :
  1. Changes from baseline in body fat percentage [ Time Frame: baseline, 4,8,12,16 weeks ]
  2. Changes from baseline in fat mass [ Time Frame: baseline, 4,8,12,16 weeks ]
  3. Changes from baseline in Waist circumference [ Time Frame: baseline, 4,8,12,16 weeks ]
  4. Changes from baseline in Waist/hip ratio [ Time Frame: baseline, 4,8,12,16 weeks ]
  5. Changes from baseline in Body mass index [ Time Frame: baseline, 4,8,12,16 weeks ]
  6. Changes from baseline in Lipid profile [ Time Frame: Screening visit, 12 weeks ]
  7. Changes from baseline in C-reactive protein (CRP) [ Time Frame: Screening visit, 12 weeks ]
  8. Changes from baseline in blood glucose [ Time Frame: Screening visit, 12 weeks ]
  9. Changes from baseline in abdominal visceral fat area [ Time Frame: baseline, 12 weeks ]
  10. Korean Obesity-related Quality of Life (QoL) scale [ Time Frame: baseline, 12 weeks ]
  11. Korean version of Eating Attitudes Test-26 [ Time Frame: baseline, 12 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651454


Contacts
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Contact: Youme Ko, MD(TCM) 8229619278 meyougo@khu.ac.kr

Locations
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Korea, Republic of
Gachon University Gil Oriental Medical Hospital Recruiting
Incheon, Korea, Republic of
Contact: , Chang-Hyun Park, KMD    82327701300    chpark104@naver.com   
Sponsors and Collaborators
Gachon University Gil Oriental Medical Hospital
Sangji University Oriental Medical Hospital, Korea
DongGuk University
Investigators
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Principal Investigator: Yun-Kyung Song, KMD Gachon University Gil Oriental Medical Hospital

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Responsible Party: Yun-Kyung Song, KMD, PhD, Gachon University Gil Oriental Medical Hospital
ClinicalTrials.gov Identifier: NCT02651454     History of Changes
Other Study ID Numbers: ISEE_2015_OBESITY
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yun-Kyung Song, Gachon University Gil Oriental Medical Hospital:
metabolic syndrome
Daesiho-tang
Taeeumjowi-tang
Korean medicine

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases