Clinical trial NCT02651454: 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: 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 -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Syndrome
Obesity
Keywords: metabolic syndrome
Daesiho-tang
Taeeumjowi-tang
Korean medicine
Lead sponsor: Gachon University Gil Oriental Medical Hospital
Sponsor class: OTHER
Collaborators: name: Sangji University Oriental Medical Hospital, Korea
name: DongGuk University
First posted: 2016-01-11
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
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 Daesiho-tang and Taeeumjowi-tang on Korean obese Women with metabolic syndrome Risk factors


Eligibility 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

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, 4,8,12,16 weeks
measure: Changes from baseline in fat mass
timeFrame: baseline, 4,8,12,16 weeks
measure: Changes from baseline in Waist circumference
timeFrame: baseline, 4,8,12,16 weeks
measure: Changes from baseline in Waist/hip ratio
timeFrame: baseline, 4,8,12,16 weeks
measure: Changes from baseline in Body mass index
timeFrame: baseline, 4,8,12,16 weeks
measure: Changes from baseline in Lipid profile
timeFrame: Screening visit, 12 weeks
measure: Changes from baseline in C-reactive protein (CRP)
timeFrame: Screening visit, 12 weeks
measure: Changes from baseline in blood glucose
timeFrame: Screening visit, 12 weeks
measure: Changes from baseline in abdominal visceral fat area
timeFrame: baseline, 12 weeks
measure: Korean Obesity-related Quality of Life (QoL) scale
timeFrame: baseline, 12 weeks
measure: Korean version of Eating Attitudes Test-26
timeFrame: baseline, 12 weeks
Other outcomes:
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, KMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HJ, Ko Y, Kim H, Cha YY, Jang BH, Song YK, Ko SG. 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 study protocol clinical trial. Medicine (Baltimore). 2020 Jan;99(5):e18955. doi: 10.1097/MD.0000000000018955.