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 -

NCT ID: NCT02651454

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2020-12-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Daesiho-tang

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

Group Type: EXPERIMENTAL

Daesiho-tang

Intervention Type: DRUG

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

Jowiseungcheung-tang

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

Group Type: EXPERIMENTAL

Chowiseungcheng-tang

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Daesiho-tang

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

Intervention Type: DRUG

Chowiseungcheng-tang

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

DSHT; Elsion Granule; CST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sangji University Oriental Medical Hospital, Korea

UNKNOWN

Sponsor Role: collaborator

DongGuk University

OTHER

Sponsor Role: collaborator

Gachon University Gil Oriental Medical Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yun-Kyung Song

KMD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yun-Kyung Song, KMD

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Oriental Medical Hospital

Locations

Gachon University Gil Oriental Medical Hospital

Incheon, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 32000419 (View on PubMed)

Other Identifiers

ISEE_2015_OBESITY

Identifier Type: -

Identifier Source: org_study_id