Evaluation of the Efficacy of Chinese Herbal Medicine in Patients With Obesity

NCT ID: NCT04481464

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shan-Yu Su

Attending Physician, Traditional Chinese Medicine Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Shan-Yu Su, MD PhD

Role: CONTACT

886-04-2205-2121 ext. 4561

Hao-Hsiu Hung, MD

Role: CONTACT

886-04-2205-2121 ext. 4563

References

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Pi-Sunyer X. The medical risks of obesity. Postgrad Med. 2009 Nov;121(6):21-33. doi: 10.3810/pgm.2009.11.2074.

Reference Type BACKGROUND
PMID: 19940414 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27727194 (View on PubMed)

Cheung BM, Cheung TT, Samaranayake NR. Safety of antiobesity drugs. Ther Adv Drug Saf. 2013 Aug;4(4):171-81. doi: 10.1177/2042098613489721.

Reference Type BACKGROUND
PMID: 25114779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19344551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25417736 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25128422 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27322312 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17367157 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24556223 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26626587 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29234439 (View on PubMed)

Other Identifiers

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CMUH109-REC2-101

Identifier Type: -

Identifier Source: org_study_id

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