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 -

NCT02651454 | Completed Phase 4

• 1 other identifier: ISEE_2015_OBESITY
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Metabolic Syndrome; Obesity

Keywords

metabolic syndrome; Daesiho-tang; Taeeumjowi-tang; Korean medicine

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in body weight

  baseline, 12 weeks

Secondary Outcomes (11)

• 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

Study Arms (3)

Daesiho-tang

EXPERIMENTAL

Dose: 6g, three times a day, each taken before or between meals for 12 weeks

Drug: Daesiho-tang

Jowiseungcheung-tang

EXPERIMENTAL

Dose: 6g, three times a day, each taken before or between meals for 12 weeks

Drug: Chowiseungcheng-tang

Placebo

PLACEBO COMPARATOR

Dose: 6g, three times a day, each taken before or between meals for 12 weeks

Drug: Placebo

Interventions

Daesiho-tang DRUG

Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.

Also known as: DSHT, Elsion Granule

Daesiho-tang

Chowiseungcheng-tang DRUG

Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: Hanzung Pharmaceutical. co. Ltd.

Also known as: CST

Jowiseungcheung-tang

Placebo DRUG

Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gachon University Gil Oriental Medical Hospital: lead
• Sangji University Oriental Medical Hospital, Korea: collaborator
• DongGuk University: collaborator

Study Sites (1)

Gachon University Gil Oriental Medical Hospital

Incheon, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32000419 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Yun-Kyung Song, KMD

  Gachon University Gil Oriental Medical Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: KMD, PhD

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 11, 2016
• Study Start: December 31, 2015
• Primary Completion: May 2, 2020
• Study Completion: December 2, 2020
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

KR (1)