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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22483238
Publication citations
-
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.