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12 February 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| The efficacy and safety of a Korean traditional medicine named 'Taeumjowi-tang' on obese patients |
| ISRCTN | ISRCTN87153759 |
| ClinicalTrials.gov identifier | |
| Public title | The efficacy and safety of a Korean traditional medicine named 'Taeumjowi-tang' on obese patients |
| Scientific title | A double blind, randomised, multicentre, placebo-controlled trial to evaluate the efficacy and safety of TJ001 on obese patients |
| Acronym | N/A |
| Serial number at source | CCRG_08_02 |
| Study hypothesis |
'Taeeumjowi-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. |
| Lay summary | Not provided at time of registration |
| 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 |
| Countries of recruitment | Korea, South |
| Disease/condition/study domain | Obesity |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 08/04/2009 |
| Anticipated end date | 30/06/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | A total of 104 patients |
| Interventions |
1. Treatment group: TJ001 (Taeeumjowi-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) |
| Primary outcome measure(s) | Weight reduction (over 5%), measured at baseline and 12 weeks |
| 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 |
| Sources of funding | Korea Health Industry Development Institute (South Korea) |
| Trial website | |
| Publications | |
| Contact name | Dr Seong-Gyu Ko |
| Address |
Department of Preventive Medicine
College of Oriental Medicine Kyung Hee University Hoegi-Dong Dongdaemun-Gu |
| City/town | Seoul |
| Zip/Postcode | 130-701 |
| Country | Korea, South |
| Tel | +82 (0)2 961 0329 |
| Fax | +82 (0)2 966 1165 |
| khuksg@gmail.com | |
| Sponsor | Korea Health Industry Development Institute (South Korea) |
| Address |
57-1 Noryangjin-Dong,
Dongjak-Gu |
| City/town | Seoul |
| Zip/Postcode | 156-800 |
| Country | Korea, South |
| Tel | +82 (0)2 194 7300 |
| Fax | +82 (0)2 824 1760 |
| webmaster@khidi.or.kr | |
| Sponsor website: | http://www.khidi.or.kr |
| Date applied | 24/03/2010 |
| Last edited | 14/12/2011 |
| Date ISRCTN assigned | 07/04/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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