Clinical trial NCT03479346: Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With or Without Metabolic Syndrome Risk Factors - A Study Protocol for a Double-blind, Randomised, Multi-center, Placebo-controlled Clinical Trial
Official title: Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With or Without Metabolic Syndrome Risk Factors - A Study Protocol for a Double-blind, Randomised, Multi-center, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Keywords: Obesity
Metabolic syndrome
Traditional Korean Medicine
Galgeun-tang
Lead sponsor: Gachon University Gil Oriental Medical Hospital
Sponsor class: OTHER
Collaborators: name: DongGuk University
name: Wonkwang University Guangju Medical Center
name: Dongsin University Oriental Hospital
name: Kyunghee University Medical Center
First posted: 2018-03-27
Enrollment: 140
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Changes from baseline in body weight
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Changes from baseline in body fat percentage
timeFrame: baseline, 4,8,12 weeks
measure: Changes from baseline in fat mass
timeFrame: baseline, 4,8,12 weeks
measure: Changes from baseline in Waist circumference
timeFrame: baseline, 4,8,12 weeks
measure: Changes from baseline in Waist/hip ratio
timeFrame: baseline, 4,8,12 weeks
measure: Changes from baseline in Body mass index
timeFrame: baseline, 4,8,12 weeks
measure: Changes from baseline in Lipid profile
timeFrame: Screening visit, 12 weeks
measure: Changes from baseline in C-reactive protein (CRP)
timeFrame: baseline, 12 weeks
measure: Changes from baseline in blood glucose
timeFrame: Screening visit, 12 weeks
measure: European Quality of life 5 Dimension(EQ5D)
timeFrame: baseline, 12 weeks
measure: Changes from baseline in serum leptin
timeFrame: baseline, 12 weeks
measure: Korean version of Western Ontario and McMasters Universities Oateoarthritis Index
timeFrame: baseline, 12, 16 weeks
measure: cost per QALY(Quality Adjusted Life Years) gained
timeFrame: 6 months or 1 year
measure: Economic evaluation (medical costs)
timeFrame: baseline, 4,8,12,16,20,24 weeks
measure: Economic evaluation (time-related costs)
timeFrame: baseline, 4,8,12,16,20,24 weeks
measure: Economic evaluation (lost productivity costs)
timeFrame: baseline, 4,8,12,16,20,24 weeks
Other outcomes:
measure: Changes from baseline in Kellgren-Lawrence grade
timeFrame: baseline, 12 weeks
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Oriental Medical Hospital
Study officials:
affiliation: Gachon University Gil Oriental Medical Hospital
name: Yun-Kyung Song, PhD
role: PRINCIPAL_INVESTIGATOR
References: