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 -

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

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome
• Intervention / Treatment: Drug: Daesiho-tang; Drug: Chowiseungcheng-tang; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Gachon University Gil Oriental Medical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daesiho-tang; Dose: 6g, three times a day, each taken before or between meals for 12 weeks	Drug: Daesiho-tang; Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.; Other Names: DSHT; Elsion Granule
Experimental: Jowiseungcheung-tang; Dose: 6g, three times a day, each taken before or between meals for 12 weeks	Drug: Chowiseungcheng-tang; Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: Hanzung Pharmaceutical. co. Ltd.; Other Names: CST
Placebo Comparator: Placebo; Dose: 6g, three times a day, each taken before or between meals for 12 weeks	Drug: Placebo; Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in body weight	baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in body fat percentage	baseline, 4,8,12,16 weeks
Changes from baseline in fat mass	baseline, 4,8,12,16 weeks
Changes from baseline in Waist circumference	baseline, 4,8,12,16 weeks
Changes from baseline in Waist/hip ratio	baseline, 4,8,12,16 weeks
Changes from baseline in Body mass index	baseline, 4,8,12,16 weeks
Changes from baseline in Lipid profile	Screening visit, 12 weeks
Changes from baseline in C-reactive protein (CRP)	Screening visit, 12 weeks
Changes from baseline in blood glucose	Screening visit, 12 weeks
Changes from baseline in abdominal visceral fat area	baseline, 12 weeks
Korean Obesity-related Quality of Life (QoL) scale	baseline, 12 weeks
Korean version of Eating Attitudes Test-26	baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Gachon University Gil Oriental Medical Hospital
• Collaborators: DongGuk University; Sangji University Oriental Medical Hospital, Korea
• Investigators: Principal Investigator: Yun-Kyung Song, KMD, Gachon University Gil Oriental Medical Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2015
• Primary Completion (Actual): May 2, 2020
• Study Completion (Actual): December 2, 2020

Study Registration Dates

• First Submitted: January 5, 2016
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 11, 2016

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 9, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: metabolic syndrome; Korean medicine; Daesiho-tang; Taeeumjowi-tang
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: ISEE_2015_OBESITY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED