Exploring the efficacy and safety of herbal medicine on Korean obese women with or without metabolic syndrome risk factors: A study protocol for a double-blind, randomized, multi-center, placebo-controlled clinical trial
The prevalence of obesity among women is increasing. Obesity is associated with various metabolic syndromes; conventional treatments are limited and may induce serious adverse events due to polytherapy regimens. Currently, demands for complementary and alternative medicine that has a proven safety p...
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| Veröffentlicht in: | Medicine (Baltimore) 2020-07, Vol.99 (28), p.e21153-e21153 |
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| creator | Ko, Youme Kim, Hyun-Ju Kim, Hojun Choi, Jin-Bong Kwon, Young-Dal Jung, Won-Seok Jang, Bo-Hyoung Kim, NamKwen Song, Yun-Kyung Ko, Seong-Gyu |
| description | The prevalence of obesity among women is increasing. Obesity is associated with various metabolic syndromes; conventional treatments are limited and may induce serious adverse events due to polytherapy regimens. Currently, demands for complementary and alternative medicine that has a proven safety profile for the treatment of obesity with or without metabolic risk factors are increasing.Our team of preclinical experts reported a significant anti-obesity effect of the Korean herbal medicine, Galgeun-tang (GGT). Thus, we designed this trial to explore the effects of GGT among obese women to accumulate optimal clinical evidence.Obesity is not only a component of metabolic syndrome and a factor associated with an increased risk of cardiovascular disease but is also related to insulin resistance. Previous research has confirmed that an increasing body mass index is highly related with increased risk of metabolic syndrome among overweight and obese individuals. The effectiveness of the Korean medicine herbal formula, GGT on obesity has been previously reported. The objective of this study is to assess the efficacy and safety of GGT for weight loss among obese Korean women with or without high risk for metabolic syndrome.
This study is a randomized, double-blinded, placebo-controlled, multi-center clinical trial. A total of 160 participants will be randomly distributed in 2 groups, the GGT group or the placebo group in a 1:1 ratio using a web-based randomization system. Each group will be administered GGT or placebo 3 times a day for 12 weeks. The primary endpoint is to assess the change in weight from baseline. The secondary endpoints are the following: the changes in body composition measurements, anthropomorphic measurements, obesity screening Laboratory tests, patient self-reported questionnaires, and economic evaluation outcomes. Adverse events will also be reported.
The findings of this study will confirm methodologies regarding the efficacy and safety of GGT for weight loss among obese Korean women with or without metabolic risk factors. |
| doi_str_mv | 10.1097/MD.0000000000021153 |
| format | Article |
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This study is a randomized, double-blinded, placebo-controlled, multi-center clinical trial. A total of 160 participants will be randomly distributed in 2 groups, the GGT group or the placebo group in a 1:1 ratio using a web-based randomization system. Each group will be administered GGT or placebo 3 times a day for 12 weeks. The primary endpoint is to assess the change in weight from baseline. The secondary endpoints are the following: the changes in body composition measurements, anthropomorphic measurements, obesity screening Laboratory tests, patient self-reported questionnaires, and economic evaluation outcomes. Adverse events will also be reported.
The findings of this study will confirm methodologies regarding the efficacy and safety of GGT for weight loss among obese Korean women with or without metabolic risk factors.</description><identifier>ISSN: 0025-7974</identifier><identifier>EISSN: 1536-5964</identifier><identifier>DOI: 10.1097/MD.0000000000021153</identifier><identifier>PMID: 32664149</identifier><language>eng</language><publisher>United States: the Author(s). Published by Wolters Kluwer Health, Inc</publisher><subject>Adult ; Aged ; Double-Blind Method ; Female ; Herbal Medicine - standards ; Humans ; Metabolic Syndrome - complications ; Metabolic Syndrome - drug therapy ; Metabolic Syndrome - epidemiology ; Middle Aged ; Obesity - complications ; Obesity - epidemiology ; Obesity - therapy ; Phytotherapy - methods ; Plants, Medicinal ; Prevalence ; Republic of Korea - epidemiology ; Risk Factors ; Study Protocol Clinical Trial ; Treatment Outcome ; Young Adult</subject><ispartof>Medicine (Baltimore), 2020-07, Vol.99 (28), p.e21153-e21153</ispartof><rights>the Author(s). Published by Wolters Kluwer Health, Inc.</rights><rights>Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3559-10698daa4a207140923597b20db3a98257394451b580e930396cb47bea04a2763</cites><orcidid>0000-0003-4478-4030</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7360330/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7360330/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,27923,27924,53790,53792</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32664149$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ko, Youme</creatorcontrib><creatorcontrib>Kim, Hyun-Ju</creatorcontrib><creatorcontrib>Kim, Hojun</creatorcontrib><creatorcontrib>Choi, Jin-Bong</creatorcontrib><creatorcontrib>Kwon, Young-Dal</creatorcontrib><creatorcontrib>Jung, Won-Seok</creatorcontrib><creatorcontrib>Jang, Bo-Hyoung</creatorcontrib><creatorcontrib>Kim, NamKwen</creatorcontrib><creatorcontrib>Song, Yun-Kyung</creatorcontrib><creatorcontrib>Ko, Seong-Gyu</creatorcontrib><title>Exploring the efficacy and safety of herbal medicine on Korean obese women with or without metabolic syndrome risk factors: A study protocol for a double-blind, randomized, multi-center, placebo-controlled clinical trial</title><title>Medicine (Baltimore)</title><addtitle>Medicine (Baltimore)</addtitle><description>The prevalence of obesity among women is increasing. Obesity is associated with various metabolic syndromes; conventional treatments are limited and may induce serious adverse events due to polytherapy regimens. Currently, demands for complementary and alternative medicine that has a proven safety profile for the treatment of obesity with or without metabolic risk factors are increasing.Our team of preclinical experts reported a significant anti-obesity effect of the Korean herbal medicine, Galgeun-tang (GGT). Thus, we designed this trial to explore the effects of GGT among obese women to accumulate optimal clinical evidence.Obesity is not only a component of metabolic syndrome and a factor associated with an increased risk of cardiovascular disease but is also related to insulin resistance. Previous research has confirmed that an increasing body mass index is highly related with increased risk of metabolic syndrome among overweight and obese individuals. The effectiveness of the Korean medicine herbal formula, GGT on obesity has been previously reported. The objective of this study is to assess the efficacy and safety of GGT for weight loss among obese Korean women with or without high risk for metabolic syndrome.
This study is a randomized, double-blinded, placebo-controlled, multi-center clinical trial. A total of 160 participants will be randomly distributed in 2 groups, the GGT group or the placebo group in a 1:1 ratio using a web-based randomization system. Each group will be administered GGT or placebo 3 times a day for 12 weeks. The primary endpoint is to assess the change in weight from baseline. The secondary endpoints are the following: the changes in body composition measurements, anthropomorphic measurements, obesity screening Laboratory tests, patient self-reported questionnaires, and economic evaluation outcomes. Adverse events will also be reported.
The findings of this study will confirm methodologies regarding the efficacy and safety of GGT for weight loss among obese Korean women with or without metabolic risk factors.</description><subject>Adult</subject><subject>Aged</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Herbal Medicine - standards</subject><subject>Humans</subject><subject>Metabolic Syndrome - complications</subject><subject>Metabolic Syndrome - drug therapy</subject><subject>Metabolic Syndrome - epidemiology</subject><subject>Middle Aged</subject><subject>Obesity - complications</subject><subject>Obesity - epidemiology</subject><subject>Obesity - therapy</subject><subject>Phytotherapy - methods</subject><subject>Plants, Medicinal</subject><subject>Prevalence</subject><subject>Republic of Korea - epidemiology</subject><subject>Risk Factors</subject><subject>Study Protocol Clinical Trial</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0025-7974</issn><issn>1536-5964</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdUk1v1DAQjRCILgu_AAnNkUNTHNtJ1hyQqrZ8iFZc4BzZzqQx9WYW2-my_FZ-DG63lA8fPNb4vefnpymK5xU7qphqX12cHrE_i1dVLR4Ui7w3Za0a-bBY5G5dtqqVB8WTGL8yVomWy8fFgeBNIyupFsXPs-8bT8FNl5BGBBwGZ7XdgZ56iHrAtAMaYMRgtIc19s66CYEm-EgB9QRkMCJsaY0TbF0agcJtpTlleNKGvLMQd1MfMgaCi1cwaJsoxNdwDDHN_Q42gRJZ8jBktoaeZuOxNN5N_SGEbIXW7gfm83r2yZUWp4ThEDZeWzRUWppSIO-xB5s5-QMeUnDaPy0eDdpHfHZXl8WXt2efT96X55_efTg5Pi-tqGtVVqxRq15rqTlrK8kUF7VqDWe9EVqteN0KJWVdmXrFUAkmVGONbA1qliltI5bFm73uZjY5oxt_QftuE9xah11H2nX_3kxu7C7pumtFw0QWXBYv7wQCfZsxpm7tokXv9YQ0x45Lnm01FZMZKvZQGyjGgMP9MxXrbuaiuzjt_p-LzHrxt8N7zu9ByAC5B2zJ53DjlZ-3GLoRtU_jrV7dKl5yxlnOiLEyd5QSvwCgPceU</recordid><startdate>20200710</startdate><enddate>20200710</enddate><creator>Ko, Youme</creator><creator>Kim, Hyun-Ju</creator><creator>Kim, Hojun</creator><creator>Choi, Jin-Bong</creator><creator>Kwon, Young-Dal</creator><creator>Jung, Won-Seok</creator><creator>Jang, Bo-Hyoung</creator><creator>Kim, NamKwen</creator><creator>Song, Yun-Kyung</creator><creator>Ko, Seong-Gyu</creator><general>the Author(s). Published by Wolters Kluwer Health, Inc</general><general>Wolters Kluwer Health</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-4478-4030</orcidid></search><sort><creationdate>20200710</creationdate><title>Exploring the efficacy and safety of herbal medicine on Korean obese women with or without metabolic syndrome risk factors: A study protocol for a double-blind, randomized, multi-center, placebo-controlled clinical trial</title><author>Ko, Youme ; Kim, Hyun-Ju ; Kim, Hojun ; Choi, Jin-Bong ; Kwon, Young-Dal ; Jung, Won-Seok ; Jang, Bo-Hyoung ; Kim, NamKwen ; Song, Yun-Kyung ; Ko, Seong-Gyu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3559-10698daa4a207140923597b20db3a98257394451b580e930396cb47bea04a2763</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Herbal Medicine - standards</topic><topic>Humans</topic><topic>Metabolic Syndrome - complications</topic><topic>Metabolic Syndrome - drug therapy</topic><topic>Metabolic Syndrome - epidemiology</topic><topic>Middle Aged</topic><topic>Obesity - complications</topic><topic>Obesity - epidemiology</topic><topic>Obesity - therapy</topic><topic>Phytotherapy - methods</topic><topic>Plants, Medicinal</topic><topic>Prevalence</topic><topic>Republic of Korea - epidemiology</topic><topic>Risk Factors</topic><topic>Study Protocol Clinical Trial</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ko, Youme</creatorcontrib><creatorcontrib>Kim, Hyun-Ju</creatorcontrib><creatorcontrib>Kim, Hojun</creatorcontrib><creatorcontrib>Choi, Jin-Bong</creatorcontrib><creatorcontrib>Kwon, Young-Dal</creatorcontrib><creatorcontrib>Jung, Won-Seok</creatorcontrib><creatorcontrib>Jang, Bo-Hyoung</creatorcontrib><creatorcontrib>Kim, NamKwen</creatorcontrib><creatorcontrib>Song, Yun-Kyung</creatorcontrib><creatorcontrib>Ko, Seong-Gyu</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Medicine (Baltimore)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ko, Youme</au><au>Kim, Hyun-Ju</au><au>Kim, Hojun</au><au>Choi, Jin-Bong</au><au>Kwon, Young-Dal</au><au>Jung, Won-Seok</au><au>Jang, Bo-Hyoung</au><au>Kim, NamKwen</au><au>Song, Yun-Kyung</au><au>Ko, Seong-Gyu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Exploring the efficacy and safety of herbal medicine on Korean obese women with or without metabolic syndrome risk factors: A study protocol for a double-blind, randomized, multi-center, placebo-controlled clinical trial</atitle><jtitle>Medicine (Baltimore)</jtitle><addtitle>Medicine (Baltimore)</addtitle><date>2020-07-10</date><risdate>2020</risdate><volume>99</volume><issue>28</issue><spage>e21153</spage><epage>e21153</epage><pages>e21153-e21153</pages><issn>0025-7974</issn><eissn>1536-5964</eissn><abstract>The prevalence of obesity among women is increasing. Obesity is associated with various metabolic syndromes; conventional treatments are limited and may induce serious adverse events due to polytherapy regimens. Currently, demands for complementary and alternative medicine that has a proven safety profile for the treatment of obesity with or without metabolic risk factors are increasing.Our team of preclinical experts reported a significant anti-obesity effect of the Korean herbal medicine, Galgeun-tang (GGT). Thus, we designed this trial to explore the effects of GGT among obese women to accumulate optimal clinical evidence.Obesity is not only a component of metabolic syndrome and a factor associated with an increased risk of cardiovascular disease but is also related to insulin resistance. Previous research has confirmed that an increasing body mass index is highly related with increased risk of metabolic syndrome among overweight and obese individuals. The effectiveness of the Korean medicine herbal formula, GGT on obesity has been previously reported. The objective of this study is to assess the efficacy and safety of GGT for weight loss among obese Korean women with or without high risk for metabolic syndrome.
This study is a randomized, double-blinded, placebo-controlled, multi-center clinical trial. A total of 160 participants will be randomly distributed in 2 groups, the GGT group or the placebo group in a 1:1 ratio using a web-based randomization system. Each group will be administered GGT or placebo 3 times a day for 12 weeks. The primary endpoint is to assess the change in weight from baseline. The secondary endpoints are the following: the changes in body composition measurements, anthropomorphic measurements, obesity screening Laboratory tests, patient self-reported questionnaires, and economic evaluation outcomes. Adverse events will also be reported.
The findings of this study will confirm methodologies regarding the efficacy and safety of GGT for weight loss among obese Korean women with or without metabolic risk factors.</abstract><cop>United States</cop><pub>the Author(s). Published by Wolters Kluwer Health, Inc</pub><pmid>32664149</pmid><doi>10.1097/MD.0000000000021153</doi><orcidid>https://orcid.org/0000-0003-4478-4030</orcidid><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Wolters Kluwer Open Health; IngentaConnect Free/Open Access Journals; PubMed Central; Alma/SFX Local Collection |
| subjects | Adult Aged Double-Blind Method Female Herbal Medicine - standards Humans Metabolic Syndrome - complications Metabolic Syndrome - drug therapy Metabolic Syndrome - epidemiology Middle Aged Obesity - complications Obesity - epidemiology Obesity - therapy Phytotherapy - methods Plants, Medicinal Prevalence Republic of Korea - epidemiology Risk Factors Study Protocol Clinical Trial Treatment Outcome Young Adult |
| title | Exploring the efficacy and safety of herbal medicine on Korean obese women with or without metabolic syndrome risk factors: A study protocol for a double-blind, randomized, multi-center, placebo-controlled clinical trial |
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