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Trial record 5 of 94 for:    body | Recruiting, Not yet recruiting, Available Studies | "Metabolic Syndrome X"

Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With or Without Metabolic Syndrome Risk Factors

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ClinicalTrials.gov Identifier: NCT03479346
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : August 15, 2018
Sponsor:
Collaborators:
DongGuk University
Wonkwang University Guangju Medical Center
Dongsin University Oriental Hospital
Kyunghee University Medical Center
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 GGT on Korean obese Women with or without metabolic syndrome Risk factors

Condition or disease Intervention/treatment Phase
Obesity Metabolic Syndrome Drug: GGT Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Exploring the Efficacy and Safety of Herbal Medicine(Galgeun-tang) on Korean Obese Women With or Without Metabolic Syndrome Risk Factors: A Pilot, Double Blinded, Randomized, Multi-center, Placebo Controlled Clinical Trial
Actual Study Start Date : April 28, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GGT group
Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Drug: GGT
Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Other Name: Galgeun-tang

Placebo Comparator: Placebo group
Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Drug: Placebo
Usage: 3g, 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 ]
    Estimated mean changes from baseline in body weight after 12 weeks of treatment.


Secondary Outcome Measures :
  1. Changes from baseline in body fat percentage [ Time Frame: baseline, 4,8,12 weeks ]
    Estimated mean changes from baseline in body fat percentage at different time points during treatment period

  2. Changes from baseline in fat mass [ Time Frame: baseline, 4,8,12 weeks ]
    Estimated mean changes from baseline in fat mass at different time points during treatment period

  3. Changes from baseline in Waist circumference [ Time Frame: baseline, 4,8,12 weeks ]
    Estimated mean changes from baseline in Waist circumference at different time points during treatment period

  4. Changes from baseline in Waist/hip ratio [ Time Frame: baseline, 4,8,12 weeks ]
    Estimated mean changes from baseline in Waist/hip ratio at different time points during treatment period

  5. Changes from baseline in Body mass index [ Time Frame: baseline, 4,8,12 weeks ]
    Estimated mean changes from baseline in Body mass index at different time points during treatment period

  6. Changes from baseline in Lipid profile [ Time Frame: Screening visit, 12 weeks ]
    Estimated mean changes from first visit in Lipid profile after 12 weeks of treatment.

  7. Changes from baseline in C-reactive protein (CRP) [ Time Frame: baseline, 12 weeks ]
    Estimated mean changes from baseline in C-reactive protein (CRP) after 12 weeks of treatment.

  8. Changes from baseline in blood glucose [ Time Frame: Screening visit, 12 weeks ]
    Estimated mean changes from first visit in blood glucose after 12 weeks of treatment.

  9. European Quality of life 5 Dimension(EQ5D) [ Time Frame: baseline, 12 weeks ]
    EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem).

  10. Changes from baseline in serum leptin [ Time Frame: baseline, 12 weeks ]
    Estimated mean changes from first visit in serum leptin after 12 weeks of treatment.

  11. Korean version of Western Ontario and McMasters Universities Oateoarthritis Index [ Time Frame: baseline, 12, 16 weeks ]
    Determination of patient's knee function and pain

  12. cost per QALY(Quality Adjusted Life Years) gained [ Time Frame: 6 months or 1 year ]
    The cost per QALY gained is calculated according to normal health-economic evaluation models.

  13. Economic evaluation (medical costs) [ Time Frame: baseline, 4,8,12,16,20,24 weeks ]
    Economic evaluation of medical costs will be performed to assess cost-effectiveness of the 2 groups.

  14. Economic evaluation (time-related costs) [ Time Frame: baseline, 4,8,12,16,20,24 weeks ]
    Economic evaluation of time-related costs will be performed to assess cost-effectiveness of the 2 groups.

  15. Economic evaluation (lost productivity costs) [ Time Frame: baseline, 4,8,12,16,20,24 weeks ]
    Economic evaluation of lost productivity costs will be performed to assess cost-effectiveness of the 2 groups.


Other Outcome Measures:
  1. Changes from baseline in Kellgren-Lawrence grade [ Time Frame: baseline, 12 weeks ]
    Determination of patient's knee condition



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female aged 19 to 65 years

    • Subject must included at least one or more of the following symptoms below;

      • BMI of 30 kg/㎡ or more;
      • BMI between 27 and 29.9kg/㎡ with non-insulin-dependent diabetes mellitus, taking medication or fasting blood glucose > 126mg/dL at the screening visit
      • BMI between 27 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:

  • Subjects who had experience with allergic reaction on investigational drug(any ingredients of IP)

    • Subjects who has diabetes as comorbidity, had experienced the elevation of blood glucose by ephedrine
    • Subjects who had experienced rash, rubefaction, or itchiness by GGT administration
    • Subjects who usually feel fatigue due to hyperhidrosis
    • Subjects who experienced other allergic reactions
  • Subjects who had 10 percent reduction in body weight over 6 months
  • Subjects who decided to quit smoking over the last 3 months or have irregular smoking habits
  • Subjects who have endocrine diseases associated with weight gain, such as hypothyroidism, Cushing's syndrome, etc.
  • Subjects who have heart disease (heart failure, angina pectoris, myocardial infarction)
  • Subjects who have uncontrolled hypertension despite the use of antihypertensive drugs (SBP > 145 mmHg or DBP > 95 mmHg)
  • Subjects who have uncontrolled diabetes despite the use of drugs (FBS>7.8 mmol/L (140 mg/dL))
  • Subjects who have severe renal disability (SCr > 2.0 mg/dL)
  • Subjects who have severe liver disability (2.5 fold of normal high range value on Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], alkaline phosphatase [ALP])
  • Subjects who have poor digestion(anorexia, stomach discomfort, nausea, vomiting etc) or have the history of eating disorder such as anorexia nervosa or bulimia nervosa, etc.(KEAT-26 < 20)
  • 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
  • Subjects who had a use of drugs that can increase blood pressure or heart rate within a week, such as, Decongestants, cough, cold, allergy treatments that include the ingredients of phenylpropanolamine, ephedrine, pseudoephedrine
  • Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse)
  • Subjects who have diseases that may occur hypokalemia (hypomagnesemia, Bartter syndrome, Gitelman syndrome, diseases that can cause high aldosteronism etc.) or have cardiac dysrhythmia
  • Difficult to measure anthropometric dimensions because of anatomical change such as resection
  • History of weight loss surgery, such as bariatric surgery, etc.
  • Edema or dysuria
  • Malignant tumour or lung disease
  • Cholelithiasis
  • History of narrow angle glaucoma
  • Subjects who have nervous or psychological medical history or presently suffer from the following diseases: depression, manic disorder, bipolar disorder, schizophrenia, epilepsy, alcoholism, anorexia, hyperphagia, etc.
  • Subjects who have history of stroke or temporary ischemic cardioplegia
  • 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

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): NCT03479346


Contacts
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Contact: Youme Ko, MA 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: youme Ko, MA    8229619278    meyougo@khu.ac.kr   
Sponsors and Collaborators
Gachon University Gil Oriental Medical Hospital
DongGuk University
Wonkwang University Guangju Medical Center
Dongsin University Oriental Hospital
Kyunghee University Medical Center
Investigators
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Principal Investigator: Yun-Kyung Song, PhD Gachon University Gil Oriental Medical Hospital

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Responsible Party: Yun-Kyung Song, Principal investigator, Gachon University Gil Oriental Medical Hospital
ClinicalTrials.gov Identifier: NCT03479346     History of Changes
Other Study ID Numbers: ISEE_2017_GGT
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yun-Kyung Song, Gachon University Gil Oriental Medical Hospital:
Obesity
Metabolic syndrome
Traditional Korean Medicine
Galgeun-tang

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