ObesityNCT04481464
Evaluation of the Efficacy of Chinese Herbal Medicine in Patients With Obesity
An observational study of Obesity, run by China Medical University Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged above 20 years old, diagnosed of obesity (ICD-9: 278.00) and received herbal treatment during january 1, 2007 and December 31, 2019.
Who may be able to join
- 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.
Who cannot join
- Patients who were pregnant or breast feeding during treatment period.
- Patients who were diagnosed of hopothyroidism or Cushing's disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Obesity
- Keywords
- obesity, Chinese herbal medicine, efficacy, side effect
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight change
Record the body weight change form the clinical records of obese patients
Measured: The change of body weight is measured monthly from the beginning of the herbal treatment through study completion, an average of 2 years.
Secondary outcomes (2)
Side effects
Record the frequency of side effects from the clinical records of obese patients
Measured: The frequency of side effects is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.
Comorbidity
Record the frequency of comorbidities from the clinical records of obese patients
Measured: The frequency of comorbidities is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Nov 2020 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shan-Yu Su, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481464
- Sponsor's protocol ID
- CMUH109-REC2-101
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pi-Sunyer X. The medical risks of obesity. Postgrad Med. 2009 Nov;121(6):21-33. doi: 10.3810/pgm.2009.11.2074.
PubMed 19940414Sun 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.
PubMed 27727194Cheung BM, Cheung TT, Samaranayake NR. Safety of antiobesity drugs. Ther Adv Drug Saf. 2013 Aug;4(4):171-81. doi: 10.1177/2042098613489721.
PubMed 25114779Monkhouse 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.
PubMed 19344551Zhang 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.
PubMed 25417736Choi 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.
PubMed 25128422Kho 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.
PubMed 27322312Karu 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.
PubMed 17367157Kim 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.
PubMed 24556223Li 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.
PubMed 26626587Liu 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.
PubMed 29234439
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Chinese Herbal Medicine in Patients With Obesity: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04481464
- Acronym / sponsor ID
- CMUH109-REC2-101
- Conditions
- Obesity
- Keywords
- obesity, Chinese herbal medicine, efficacy, side effect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged above 20 years old, diagnosed of obesity (ICD-9: 278.00) and received herbal treatment during january 1, 2007 and December 31, 2019.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who were pregnant or breast feeding during treatment period.
- Patients who were diagnosed of hopothyroidism or Cushing's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body weight change
Time frame: 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
2 secondary outcomes
Side effects
Time frame: The frequency of side effects is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.
Comorbidity
Time frame: The frequency of comorbidities is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Background: PubMed 19940414Pi-Sunyer X. The medical risks of obesity. Postgrad Med. 2009 Nov;121(6):21-33. doi: 10.3810/pgm.2009.11.2074.
- Background: PubMed 27727194Sun 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.
- Background: PubMed 25114779Cheung BM, Cheung TT, Samaranayake NR. Safety of antiobesity drugs. Ther Adv Drug Saf. 2013 Aug;4(4):171-81. doi: 10.1177/2042098613489721.
- Background: PubMed 19344551Monkhouse 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.
- Background: PubMed 25417736Zhang 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.
- Background: PubMed 25128422Choi 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.
- Background: PubMed 27322312Kho 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.
- Background: PubMed 17367157Karu 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.
- Background: PubMed 24556223Kim 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.
- Background: PubMed 26626587Li 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.
- Background: PubMed 29234439Liu 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.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shan-Yu Su, MD PhD (886-04-2205-2121 ext. 4561, shanyusu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight change (time frame: The change of body weight is measured monthly from the beginning of the herbal treatment through study completion, an average of 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04481464, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.