NCT01724099

Brief Summary

The hypothesis of this study is obese patient with Euiiyin-tang for 12 weeks will show a superior reduction compared to those taking the placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
Completed

Started Apr 2013

Longer than P75 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 9, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

1.8 years

First QC Date

November 2, 2012

Last Update Submit

June 13, 2018

Conditions

Obesity

Keywords

ObesityHerbal productKorean Medicine

Outcome Measures

Primary Outcomes (1)

  • Weight reduction

    between baseline and 12 weeks

Secondary Outcomes (11)

  • C-reactive protein (CRP)

    baseline and 12 weeks

  • Blood pressure

    baseline, 4 weeks, 8 weeks, and 12 weeks

  • Blood glucose

    baseline and 12 weeks

  • Waist/hip ratio

    4 weeks, 8 weeks, and 12 weeks

  • Waist circumference

    baseline, 4 weeks, 8 weeks, and 12 weeks

  • +6 more secondary outcomes

Study Arms (2)

Euiiyin-tang

EXPERIMENTAL

powder type, 3 times per day before the meal, 12 weeks total

Drug: Euiiyin-tang

Placebo

PLACEBO COMPARATOR

powder type, 3 times per day before the meal, 12 weeks total

Drug: Placebo

Interventions

Euiiyin-tangDRUG

Korean medicinal herbal drug

Euiiyin-tang
PlaceboDRUG

Placebo drug, same odor and formula as Euiiyin-tang

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18-65 years old
  • Patients applying to one of the followings 2.1. BMI 30kg/m2 or over 2.2. BMI 27-29.9kg/m2 with hypertension in a proper treatment and blood pressure controlled (SBP ≤ 145mmHg, DBP ≤ 95mmHg) 2.3. BMI 27-29.9kg/m2 with non-insulin-dependent diabetes mellitus and fasting blood glucose \< 7.8mmol/L(140mg/dL) 2.4. BMI 27-29.9kg/m2 with hyperlipidemia in a proper treatment 2.5. BMI 27-39.9kg/m2 and Total cholesterol 236mg/dL or over or Triglyceride 150mg/dL or over at screening
  • Agreed to low-calorie diet during the trial
  • Written informed consent of the trial

You may not qualify if:

  • Endocrine disease such as hypothyroidism, Cushing's syndrome, etc.
  • Heart disease (heart failure, angina pectoris, myocardial infarction)
  • Uncontrolled hypertension (SBP \> 145 mmHg or DBP \> 95 mmHg)
  • Malignant tumour or lung disease
  • 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)
  • Non-insulin-dependent diabetes mellitus and fasting blood sugar 7.8mmol/L (140 mg/dL) or over
  • Narrow angle glaucoma
  • History or existence of neurological or psychological disease (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia, etc.)
  • History of stroke or temporary ischemic cardioplegia
  • History or existence of eating disorder such as anorexia nervosa or bulimia nervosa, etc.
  • Use of medication that could have effect on weight within last 3 months (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medication having effect on absorption, metabolism, excretion)
  • Use of β--blocker or diuretic as hypertension medication within last 3 months
  • Use of medication for central nervous system or central active weight reduction medication
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

Location

Related Publications (2)

  • Cheon C, Song YK, Ko SG. Efficacy and safety of Euiiyin-tang in Korean women with obesity: A randomized, double-blind, placebo-controlled, multicenter trial. Complement Ther Med. 2020 Jun;51:102423. doi: 10.1016/j.ctim.2020.102423. Epub 2020 May 21.

    PMID: 32507436DERIVED

  • Cheon C, Jang S, Park JS, Ko Y, Kim DS, Lee BH, Song HJ, Song YK, Jang BH, Shin YC, Ko SG. Euiiyin-tang in the treatment of obesity: study protocol for a randomised controlled trial. Trials. 2017 Jun 21;18(1):289. doi: 10.1186/s13063-017-2039-8.

    PMID: 28637494DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yoon-kyung SONG, KMD

    Gachon University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 2, 2012

First Posted

November 9, 2012

Study Start

April 1, 2013

Primary Completion

February 1, 2015

Study Completion

June 1, 2017

Last Updated

June 15, 2018

Record last verified: 2018-06

Locations

KR(1)