The efficacy and safety of a Korean traditional medicine named 'Taeumjowi-tang' on obese patients

ISRCTN ISRCTN87153759
DOI https://doi.org/10.1186/ISRCTN87153759
Protocol serial number CCRG_08_02
Sponsor Korea Health Industry Development Institute (South Korea)
Funder Korea Health Industry Development Institute (South Korea)
Submission date
24/03/2010
Registration date
07/04/2010
Last edited
05/09/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Seong-Gyu Ko
Scientific

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

Study information

Primary study designInterventional
Study designMulticentre double blind randomised placebo controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA double blind, randomised, multicentre, placebo-controlled trial to evaluate the efficacy and safety of TJ001 on obese patients
Study objectives'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(s)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)
Health condition(s) or problem(s) studiedObesity
Intervention1. 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date30/06/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexAll
Target sample size at registration104
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment08/04/2009
Date of final enrolment30/06/2012

Locations

Countries of recruitment

  • Korea, South

Study participating centre

Department of Preventive Medicine
Seoul
130-701
Korea, South

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 07/04/2012 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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