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 -

Obesity 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 -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651454
• Other study ID #: ISEE_2015_OBESITY
• Status: Completed
• Phase: Phase 4
• Start date: December 31, 2015
• Est. completion date: December 2, 2020

Study information

• Verified date: April 2021
• Source: Gachon University Gil Oriental Medical Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2, 2020
• Est. primary completion date: May 2, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity
• Syndrome

Intervention

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.
• Chowiseungcheng-tang
Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: Hanzung Pharmaceutical. co. Ltd.
• Placebo
Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Oriental Medical Hospital	Incheon

Sponsors (3)

Lead Sponsor	Collaborator
Gachon University Gil Oriental Medical Hospital	DongGuk University, Sangji University Oriental Medical Hospital, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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