<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04481464</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH109-REC2-101</org_study_id>
    <nct_id>NCT04481464</nct_id>
  </id_info>
  <brief_title>Evaluation of the Efficacy of Chinese Herbal Medicine in Patients With Obesity</brief_title>
  <official_title>Evaluation of the Efficacy of Chinese Herbal Medicine in Patients With Obesity: a Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity is defined as abnormal or excessive fat accumulation. It is a complex disease with&#xD;
      multifactorial etiology. Although the prevalence of obesity is generally greater in elders&#xD;
      and women, obesity rates have increased in all ages and both sexes in recent years. Obesity&#xD;
      or overweight also has a higher risk of diabetes, metabolic syndrome, dyslipidemia,&#xD;
      hypertension, hyperuricemia, gout, osteoarthritis, cardiovascular disease, coronary artery&#xD;
      disease, breast cancer, endometrial cancer and colorectal cancer. The body mass index (BMI),&#xD;
      calculated as weight in kilograms divided by the square of height in meters, is widely used&#xD;
      to define overweight and obesity in clinical studies. In Taiwan, subjects with BMI between 24&#xD;
      and 27 were diagnosed of overweight, and those with BMI over 27 were diagnosed of obesity.&#xD;
&#xD;
      Chinese herbal medicine (CHM) was widely used in the treatment of obesity. The main purpose&#xD;
      of CHM treatment is to promote metabolism, suppress appetite and block intestinal digestion&#xD;
      and absorption of fat. Since there are various adverse effects of anti-obesity medicines, and&#xD;
      there are surgical complications including infection and anastomotic stenosis, patients may&#xD;
      seek CHM for losing weight. Many studies have indicated the efficacy of single herb in the&#xD;
      treatment of obesity.&#xD;
&#xD;
      Currently, the amount of computerized clinical data is increasing rapidly with the adoption&#xD;
      of electronic medical records. The study is expected to collect the medical records,&#xD;
      including the data of body weight, related side effects and biochemical data of each&#xD;
      individual. By comparing the change of related data before and after CHM treatment, we could&#xD;
      evaluate the efficacy of CHM in patients with obesity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2020</start_date>
  <completion_date type="Anticipated">November 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Body weight change</measure>
    <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.</time_frame>
    <description>Record the body weight change form the clinical records of obese patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>The frequency of side effects is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.</time_frame>
    <description>Record the frequency of side effects from the clinical records of obese patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comorbidity</measure>
    <time_frame>The frequency of comorbidities is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.</time_frame>
    <description>Record the frequency of comorbidities from the clinical records of obese patients</description>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Obesity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged above 20 years old, diagnosed of obesity (ICD-9: 278.00) and received herbal&#xD;
        treatment during january 1, 2007 and December 31, 2019.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with the diagnosis of obesity (ICD-9: 278.00) and received Chinese herbal&#xD;
             treatment for obesity in outpatient clinic during January 1, 2007 and December 31,&#xD;
             2019.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who were pregnant or breast feeding during treatment period.&#xD;
&#xD;
          -  Patients who were diagnosed of hopothyroidism or Cushing's disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shan-Yu Su, MD PhD</last_name>
    <phone>886-04-2205-2121</phone>
    <phone_ext>4561</phone_ext>
    <email>shanyusu@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hao-Hsiu Hung, MD</last_name>
    <phone>886-04-2205-2121</phone>
    <phone_ext>4563</phone_ext>
    <email>u9702403@cmu.edu.tw</email>
  </overall_contact_backup>
  <reference>
    <citation>Pi-Sunyer X. The medical risks of obesity. Postgrad Med. 2009 Nov;121(6):21-33. doi: 10.3810/pgm.2009.11.2074.</citation>
    <PMID>19940414</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27727194</PMID>
  </reference>
  <reference>
    <citation>Cheung BM, Cheung TT, Samaranayake NR. Safety of antiobesity drugs. Ther Adv Drug Saf. 2013 Aug;4(4):171-81. doi: 10.1177/2042098613489721.</citation>
    <PMID>25114779</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19344551</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25417736</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25128422</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27322312</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17367157</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24556223</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26626587</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>29234439</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University Hospital</investigator_affiliation>
    <investigator_full_name>Shan-Yu Su</investigator_full_name>
    <investigator_title>Attending Physician, Traditional Chinese Medicine Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>Chinese herbal medicine</keyword>
  <keyword>efficacy</keyword>
  <keyword>side effect</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04481464
org study id: CMUH109-REC2-101
nct id: NCT04481464
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Retrospective
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.
description: Record the body weight change form the clinical records of obese patients
measure: 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.
description: Record the frequency of side effects from the clinical records of obese patients
measure: Comorbidity
time frame: The frequency of comorbidities is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.
description: Record the frequency of comorbidities from the clinical records of obese patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shan-Yu Su, MD PhD
phone: 886-04-2205-2121
phone ext: 4561
email: shanyusu@gmail.com
last name: Hao-Hsiu Hung, MD
phone: 886-04-2205-2121
phone ext: 4563
email: u9702403@cmu.edu.tw
citation: Pi-Sunyer X. The medical risks of obesity. Postgrad Med. 2009 Nov;121(6):21-33. doi: 10.3810/pgm.2009.11.2074.
PMID: 19940414
citation: 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.
PMID: 27727194
citation: Cheung BM, Cheung TT, Samaranayake NR. Safety of antiobesity drugs. Ther Adv Drug Saf. 2013 Aug;4(4):171-81. doi: 10.1177/2042098613489721.
PMID: 25114779
citation: 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.
PMID: 19344551
citation: 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.
PMID: 25417736
citation: 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.
PMID: 25128422
citation: 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.
PMID: 27322312
citation: 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.
PMID: 17367157
citation: 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.
PMID: 24556223
citation: 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.
PMID: 26626587
citation: 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.
PMID: 29234439
responsible party type: Principal Investigator
investigator affiliation: China Medical University Hospital
investigator full name: Shan-Yu Su
investigator title: Attending Physician, Traditional Chinese Medicine Obstetrics and Gynecology
mesh term: Obesity
sharing ipd: No