Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/03/2010
Date assigned
07/04/2010
Last edited
05/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Seong-Gyu Ko

ORCID ID

Contact details

Department of Preventive Medicine
College of Oriental Medicine
Kyung Hee University
Hoegi-Dong
Dongdaemun-Gu
Seoul
130-701
Korea
South
+82 (0)2 961 0329
khuksg@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CCRG_08_02

Study information

Scientific title

A double blind, randomised, multicentre, placebo-controlled trial to evaluate the efficacy and safety of TJ001 on obese patients

Acronym

Study hypothesis

'Taeumjowi-tang' is more effective than placebo on obese patients

Please note as of 14/12/2012 anticipated end date has been modified from 30/06/2011 to 30/06/2012.

Ethics approval

1. Institutional Review Board of the Catholic University of Korea Seoul St. Mary's Hospital approved on the 24th of February 2009 (ref: KC09MNME0032)
2. Institutional Review Board of the Dongguk University Ilsan Oriental Hospital approved on the 5th of February 2009 (ref: SR-09)
3. Institutional Review Board of the Semyung University Oriental Medicine Hospital approved on the 27th of March 2009 (ref: 2008-03)
4. Institutional Review Board of the Kyungwon Gil Oriental Medical Hospital approved on the 7th of August 2008 (ref: 08-101)

Study design

Multicentre double blind randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Obesity

Intervention

1. Treatment group: TJ001 (Taeumjowi-tang) 7g, 3 times/day, 4 weeks (28 days)/visit, total 12 weeks (visit 2 - visit 5)
2. Control group: placebo 7g, 3 times/day, 4 weeks (28 days)/visit, total 12 weeks (visit 2 - visit 5)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Weight reduction (over 5%), measured at baseline and 12 weeks

Secondary outcome measures

1. Weight reduction, measured at baseline, 4, 8 and 12 weeks
2. Lipid profile and C-reactive protein (CRP), measured at baseline and 12 weeks
3. Blood pressure, measured at baseline and 12 weeks
4. Blood glucose, measured at baseline and 12 weeks
5. Waist/hip ratio, measured at baseline, 4, 8 and 12 weeks
6. Waist circumference, measured at baseline, 4, 8 and 12 weeks
7. Abdominal computed tomography, measured at baseline and 12 weeks
8. Korean Obesity-related Quality of Life (QoL) scale, measured at baseline and 12 weeks
9. Korean version of Eating Attitudes Test-26, measured at baseline and 12 weeks

Overall trial start date

08/04/2009

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A total of 104 patients

Participant exclusion criteria

1. Endocrine disease such as hypothyroidism, Cushing's syndrome, etc.
2. Heart disease (heart failure, angina pectoris, myocardial infarction)
3. Uncontrolled hypertension (SBP > 145 mmHg or DBP > 95 mmHg)
4. Malignant tumour or lung disease
5. Cholelithiasis
6. Severe renal disability (SCr > 2.0 mg/dL)
7. Severe liver disability (2.5 fold of normal high range value on Alanine Aminotransferase [ALT], Aspatate Aminotransferase [AST], alkaline phosphatase)
8. Non-insulin-dependent diabetes mellitus and fasting blood sugar 7.8mmol/L (140 mg/dL) or over
9. Narrow angle glaucoma
10. History or existence of neurological or psychological disease (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia, etc.)
11. History of stroke or temporary ischemic cardioplegia
12. History or existence of eating disorder such as anorexia nervosa or bulimia nervosa, etc.
13. 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)
14. Use of B-blocker or diuretic as hypertension medication within last 3 months
15. Use of medication for central nervous system or central active weight reduction medication
16. Forbidden treatment (Insulin, hypoglycemic agent, antidepressant, antiserotonin agent, barbiturate, antipsychotic, medication concerns of abuse)
17. Difficult to measure anthropometric dimensions because of anatomical change such as resection
18. Surgical history for weight reduction; bariatric surgery, etc.
19. Unable to follow instructions of the trial as judged by investigator
20. Women who were pregnant, lactating, planning a pregnancy or women of childbearing age who do not agree to proper contraception (birth-control pill, hormone implant, IUD, spermicide, condom, abstinence, etc.) (Women of childbearing age indicate within 2 years of menopause who did not receive hysterectomy, bilateral tubal ligation, bilateral oophorectomy, etc.)
21. Use of other investigational product within last 1 month
22. Reduction over 10% of the previous weight within 6 months
23. Decided to stop smoking within last 3 months; however, keeping irregular smoking habit

Recruitment start date

08/04/2009

Recruitment end date

30/06/2012

Locations

Countries of recruitment

Korea, South

Trial participating centre

Department of Preventive Medicine
Seoul
130-701
Korea, South

Sponsor information

Organisation

Korea Health Industry Development Institute (South Korea)

Sponsor details

57-1 Noryangjin-Dong
Dongjak-Gu
Seoul
156-800
Korea
South
+82 (0)2 194 7300
webmaster@khidi.or.kr

Sponsor type

Research organisation

Website

http://www.khidi.or.kr

Funders

Funder type

Research organisation

Funder name

Korea Health Industry Development Institute (South Korea)

Alternative name(s)

KHIDI

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Korea, South

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22483238

Publication citations

  1. Protocol

    Park S, Park JS, Cheon C, Yang YJ, An C, Jang BH, Song YK, Go H, Lee JA, Shin Y, Ko SG, A pilot study to evaluate the effect of Taeumjowi-tang on obesity in Korean adults: study protocol for a randomised, double-blind, placebo-controlled, multicentre trial., Trials, 2012, 13, 33, doi: 10.1186/1745-6215-13-33.

Additional files

Editorial Notes