- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04481464
Evaluation of the Efficacy of Chinese Herbal Medicine in Patients With Obesity
Evaluation of the Efficacy of Chinese Herbal Medicine in Patients With Obesity: a Retrospective Study
Obesity is defined as abnormal or excessive fat accumulation. It is a complex disease with multifactorial etiology. Although the prevalence of obesity is generally greater in elders and women, obesity rates have increased in all ages and both sexes in recent years. Obesity or overweight also has a higher risk of diabetes, metabolic syndrome, dyslipidemia, hypertension, hyperuricemia, gout, osteoarthritis, cardiovascular disease, coronary artery disease, breast cancer, endometrial cancer and colorectal cancer. The body mass index (BMI), calculated as weight in kilograms divided by the square of height in meters, is widely used to define overweight and obesity in clinical studies. In Taiwan, subjects with BMI between 24 and 27 were diagnosed of overweight, and those with BMI over 27 were diagnosed of obesity.
Chinese herbal medicine (CHM) was widely used in the treatment of obesity. The main purpose of CHM treatment is to promote metabolism, suppress appetite and block intestinal digestion and absorption of fat. Since there are various adverse effects of anti-obesity medicines, and there are surgical complications including infection and anastomotic stenosis, patients may seek CHM for losing weight. Many studies have indicated the efficacy of single herb in the treatment of obesity.
Currently, the amount of computerized clinical data is increasing rapidly with the adoption of electronic medical records. The study is expected to collect the medical records, including the data of body weight, related side effects and biochemical data of each individual. By comparing the change of related data before and after CHM treatment, we could evaluate the efficacy of CHM in patients with obesity.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patients with the diagnosis of obesity (ICD-9: 278.00) and received Chinese herbal treatment for obesity in outpatient clinic during January 1, 2007 and December 31, 2019.
Exclusion Criteria:
- Patients who were pregnant or breast feeding during treatment period.
- Patients who were diagnosed of hopothyroidism or Cushing's disease.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Body weight change
Lasso di tempo: The change of body weight is measured monthly from the beginning of the herbal treatment through study completion, an average of 2 years.
|
Record the body weight change form the clinical records of obese patients
|
The change of body weight is measured monthly from the beginning of the herbal treatment through study completion, an average of 2 years.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Side effects
Lasso di tempo: The frequency of side effects is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.
|
Record the frequency of side effects from the clinical records of obese patients
|
The frequency of side effects is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.
|
Comorbidity
Lasso di tempo: The frequency of comorbidities is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.
|
Record the frequency of comorbidities from the clinical records of obese patients
|
The frequency of comorbidities is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.
|
Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- Pi-Sunyer X. The medical risks of obesity. Postgrad Med. 2009 Nov;121(6):21-33. doi: 10.3810/pgm.2009.11.2074.
- Sun NN, Wu TY, Chau CF. Natural Dietary and Herbal Products in Anti-Obesity Treatment. Molecules. 2016 Oct 11;21(10):1351. doi: 10.3390/molecules21101351.
- Cheung BM, Cheung TT, Samaranayake NR. Safety of antiobesity drugs. Ther Adv Drug Saf. 2013 Aug;4(4):171-81. doi: 10.1177/2042098613489721.
- Monkhouse SJ, Morgan JD, Norton SA. Complications of bariatric surgery: presentation and emergency management--a review. Ann R Coll Surg Engl. 2009 May;91(4):280-6. doi: 10.1308/003588409X392072. Epub 2009 Apr 2.
- Zhang WL, Zhu L, Jiang JG. Active ingredients from natural botanicals in the treatment of obesity. Obes Rev. 2014 Dec;15(12):957-67. doi: 10.1111/obr.12228. Epub 2014 Nov 23.
- Choi JS, Kim JH, Ali MY, Min BS, Kim GD, Jung HA. Coptis chinensis alkaloids exert anti-adipogenic activity on 3T3-L1 adipocytes by downregulating C/EBP-alpha and PPAR-gamma. Fitoterapia. 2014 Oct;98:199-208. doi: 10.1016/j.fitote.2014.08.006. Epub 2014 Aug 12.
- Kho MC, Lee YJ, Park JH, Kim HY, Yoon JJ, Ahn YM, Tan R, Park MC, Cha JD, Choi KM, Kang DG, Lee HS. Fermented Red Ginseng Potentiates Improvement of Metabolic Dysfunction in Metabolic Syndrome Rat Models. Nutrients. 2016 Jun 16;8(6):369. doi: 10.3390/nu8060369.
- Karu N, Reifen R, Kerem Z. Weight gain reduction in mice fed Panax ginseng saponin, a pancreatic lipase inhibitor. J Agric Food Chem. 2007 Apr 18;55(8):2824-8. doi: 10.1021/jf0628025. Epub 2007 Mar 17.
- Kim BS, Song MY, Kim H. The anti-obesity effect of Ephedra sinica through modulation of gut microbiota in obese Korean women. J Ethnopharmacol. 2014 Mar 28;152(3):532-9. doi: 10.1016/j.jep.2014.01.038. Epub 2014 Feb 17.
- Li J, Ding L, Song B, Xiao X, Qi M, Yang Q, Yang Q, Tang X, Wang Z, Yang L. Emodin improves lipid and glucose metabolism in high fat diet-induced obese mice through regulating SREBP pathway. Eur J Pharmacol. 2016 Jan 5;770:99-109. doi: 10.1016/j.ejphar.2015.11.045. Epub 2015 Nov 25.
- Liu Y, Sun M, Yao H, Liu Y, Gao R. Herbal Medicine for the Treatment of Obesity: An Overview of Scientific Evidence from 2007 to 2017. Evid Based Complement Alternat Med. 2017;2017:8943059. doi: 10.1155/2017/8943059. Epub 2017 Sep 25.
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CMUH109-REC2-101
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .