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

NCT03479346 | Completed DMC

• 1 other identifier: ISEE_2017_GGT
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Metabolic Syndrome

Keywords

Obesity; Metabolic syndrome; Traditional Korean Medicine; Galgeun-tang

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in body weight

  Estimated mean changes from baseline in body weight after 12 weeks of treatment.

  baseline, 12 weeks

Secondary Outcomes (15)

• Changes from baseline in body fat percentage

  baseline, 4,8,12 weeks

• Changes from baseline in fat mass

  baseline, 4,8,12 weeks

• Changes from baseline in Waist circumference

  baseline, 4,8,12 weeks

• Changes from baseline in Waist/hip ratio

  baseline, 4,8,12 weeks

• Changes from baseline in Body mass index

  baseline, 4,8,12 weeks

Other Outcomes (1)

• Changes from baseline in Kellgren-Lawrence grade

  baseline, 12 weeks

Study Arms (2)

GGT group

EXPERIMENTAL

Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.

Drug: GGT

Placebo group

PLACEBO COMPARATOR

Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.

Drug: Placebo

Interventions

GGT DRUG

Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.

Also known as: Galgeun-tang

GGT group

Placebo DRUG

Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.

Placebo group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gachon University Gil Oriental Medical Hospital: lead
• DongGuk University: collaborator
• Wonkwang University Guangju Medical Center: collaborator
• Dongsin University Oriental Hospital: collaborator
• Kyunghee University Medical Center: collaborator

Study Sites (1)

Gachon University Gil Oriental Medical Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Interventions

galgeun-tang

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Yun-Kyung Song, PhD

  Gachon University Gil Oriental Medical Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 27, 2018
• Study Start: April 28, 2018
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)