Status:
COMPLETED
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
Lead Sponsor:
Gachon University Gil Oriental Medical Hospital
Collaborating Sponsors:
DongGuk University
Wonkwang University Guangju Medical Center
Conditions:
Obesity
Metabolic Syndrome
Eligibility:
FEMALE
19-65 years
Phase:
NA
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
- 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
- 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
Key Trial Info
Start Date :
April 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03479346
Start Date
April 28 2018
End Date
December 1 2020
Last Update
April 12 2021
Active Locations (1)
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1
Gachon University Gil Oriental Medical Hospital
Incheon, South Korea