Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial
Introduction. The etiology and pathogenesis of psoriasis are complex. Blood-heat syndrome is the core pathogenesis of psoriasis. Based on theories of Chinese medicine (CM), heat-clearing and blood-cooling (HCBC) are the primary treatment. Very few studies have investigated the pharmacological mechan...
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creator | Lv, Jing-Jing Yin, Qing-Feng Li, Wei Liu, Yan-Ping Wang, Jian-Feng Li, Bin Li, Xin Ji, Yun-Run Zhou, Dong-Mei Xu, Rong Wang, Si-Nong Zhou, Meng Zhang, Hong-Ya Zhang, Cang Li, Su Wang, Rui-Ping |
description | Introduction. The etiology and pathogenesis of psoriasis are complex. Blood-heat syndrome is the core pathogenesis of psoriasis. Based on theories of Chinese medicine (CM), heat-clearing and blood-cooling (HCBC) are the primary treatment. Very few studies have investigated the pharmacological mechanism of the CM HCBC method for treating psoriasis. This multicenter randomized controlled trial will focus on treating psoriasis blood-heat syndrome with the HCBC method using Jueyin granules (JYKL). This will be an objective and standardized evaluation of the efficacy, safety, and reproducibility of the HCBC method to obtain objective evidence meeting international standards that aim to establish a clinical standard suitable for the popular application of CM for treating psoriasis. Methods and Analysis. A five-center randomized double-blind placebo-controlled clinical design will be used in this study. At least 196 participants will be randomly assigned to receive either JYKL or placebo treatment approximately 30 minutes after meals in the morning and evening (one sachet per time, twice daily for 8 consecutive weeks). The study duration will be 17 weeks, including 1 week of screening, 8 weeks of intervention, and 8 weeks of follow-up. The patients will be evaluated every 2 weeks, and the measures will be compared with baseline values. The primary outcome measure will be the psoriasis lesion area severity index. We will also observe the recurrence rate, body surface area, physician global assessment, dermatology life quality index, quality of life index, visual analogue scale score, CM symptom score, combined drug use, and adverse events. This trial is registered with NCT03961230. |
doi_str_mv | 10.1155/2020/8942301 |
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fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7171628</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A624972402</galeid><sourcerecordid>A624972402</sourcerecordid><originalsourceid>FETCH-LOGICAL-c499t-7cfbfd816dc1236ff25dac0a92dac97a0a0d265d8db8bd35737275bf6c6e9e2b3</originalsourceid><addsrcrecordid>eNqNks1u1DAURiMEoqWwY40ssUGCUNuJ47gLpGpUCqgjRlAQO-vGPzOuPHGxE6rhWXhYHGaYAitWtuzjc--1vqJ4TPBLQhg7ppji41bUtMLkTnFIeE3Kmrbt3f2efzkoHqR0hTEVnPP7xUFFK0YaLA6LH2fWOgVqg6DX6CNYM2xQsOjdaDauR-cR-tGbhGyIaAGDM_2Q0I0bVmjuvC6HUM6DNhEGgxYpRAfJJfR59EuILp2gRQxDUMH_eg9oPvrBqewwEX3IBcPafTcaLTwo04VyFvohBu_z0WVW-YfFPQs-mUe79aj49PrscvamvHh__nZ2elGqWoih5Mp2Vrek0YrQqrGWMg0Kg6B5ERwwYE0bplvdtZ2uGK845ayzjWqMMLSrjopXW-_12K2NnhqM4OV1dGuIGxnAyb9vereSy_BNcsJJQ9sseLYTxPB1NGmQa5eU8R56E8YkaSWalon87Rl9-g96FcbY5_EmirSMYV7fUkvwRrrehlxXTVJ52tBacFpjmqkXW0rFkFI0dt8ywXIKh5zCIXfhyPiTP8fcw7_TkIHnW2Dleg037j91JjPGwi1NWEs5rn4CYl_ODA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2391855074</pqid></control><display><type>article</type><title>Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial</title><source>PubMed Central Open Access</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Wiley Online Library (Open Access Collection)</source><source>PubMed Central</source><source>Alma/SFX Local Collection</source><creator>Lv, Jing-Jing ; Yin, Qing-Feng ; Li, Wei ; Liu, Yan-Ping ; Wang, Jian-Feng ; Li, Bin ; Li, Xin ; Ji, Yun-Run ; Zhou, Dong-Mei ; Xu, Rong ; Wang, Si-Nong ; Zhou, Meng ; Zhang, Hong-Ya ; Zhang, Cang ; Li, Su ; Wang, Rui-Ping</creator><contributor>Sherman, Ronald ; Ronald Sherman</contributor><creatorcontrib>Lv, Jing-Jing ; Yin, Qing-Feng ; Li, Wei ; Liu, Yan-Ping ; Wang, Jian-Feng ; Li, Bin ; Li, Xin ; Ji, Yun-Run ; Zhou, Dong-Mei ; Xu, Rong ; Wang, Si-Nong ; Zhou, Meng ; Zhang, Hong-Ya ; Zhang, Cang ; Li, Su ; Wang, Rui-Ping ; Sherman, Ronald ; Ronald Sherman</creatorcontrib><description>Introduction. The etiology and pathogenesis of psoriasis are complex. Blood-heat syndrome is the core pathogenesis of psoriasis. Based on theories of Chinese medicine (CM), heat-clearing and blood-cooling (HCBC) are the primary treatment. Very few studies have investigated the pharmacological mechanism of the CM HCBC method for treating psoriasis. This multicenter randomized controlled trial will focus on treating psoriasis blood-heat syndrome with the HCBC method using Jueyin granules (JYKL). This will be an objective and standardized evaluation of the efficacy, safety, and reproducibility of the HCBC method to obtain objective evidence meeting international standards that aim to establish a clinical standard suitable for the popular application of CM for treating psoriasis. Methods and Analysis. A five-center randomized double-blind placebo-controlled clinical design will be used in this study. At least 196 participants will be randomly assigned to receive either JYKL or placebo treatment approximately 30 minutes after meals in the morning and evening (one sachet per time, twice daily for 8 consecutive weeks). The study duration will be 17 weeks, including 1 week of screening, 8 weeks of intervention, and 8 weeks of follow-up. The patients will be evaluated every 2 weeks, and the measures will be compared with baseline values. The primary outcome measure will be the psoriasis lesion area severity index. We will also observe the recurrence rate, body surface area, physician global assessment, dermatology life quality index, quality of life index, visual analogue scale score, CM symptom score, combined drug use, and adverse events. This trial is registered with NCT03961230.</description><identifier>ISSN: 1741-427X</identifier><identifier>EISSN: 1741-4288</identifier><identifier>DOI: 10.1155/2020/8942301</identifier><identifier>PMID: 32351609</identifier><language>eng</language><publisher>Cairo, Egypt: Hindawi Publishing Corporation</publisher><subject>Analysis ; Blood ; Care and treatment ; Chinese medicine ; Clinical trials ; Dermatology ; Etiology ; Evidence-based medicine ; Family medical history ; Heat ; International standards ; Intervention ; Medical care ; Patient safety ; Patients ; Psoriasis ; Psoriasis vulgaris ; Quality management ; Quality of life ; Skin ; Substance abuse treatment</subject><ispartof>Evidence-based complementary and alternative medicine, 2020, Vol.2020 (2020), p.1-9</ispartof><rights>Copyright © 2020 Su Li et al.</rights><rights>COPYRIGHT 2020 John Wiley & Sons, Inc.</rights><rights>Copyright © 2020 Su Li et al. This is an open access article distributed under the Creative Commons Attribution License (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. http://creativecommons.org/licenses/by/4.0</rights><rights>Copyright © 2020 Su Li et al. 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c499t-7cfbfd816dc1236ff25dac0a92dac97a0a0d265d8db8bd35737275bf6c6e9e2b3</citedby><cites>FETCH-LOGICAL-c499t-7cfbfd816dc1236ff25dac0a92dac97a0a0d265d8db8bd35737275bf6c6e9e2b3</cites><orcidid>0000-0002-8607-8874 ; 0000-0003-2525-9679</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/PMC7171628/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7171628/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,4024,27923,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32351609$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Sherman, Ronald</contributor><contributor>Ronald Sherman</contributor><creatorcontrib>Lv, Jing-Jing</creatorcontrib><creatorcontrib>Yin, Qing-Feng</creatorcontrib><creatorcontrib>Li, Wei</creatorcontrib><creatorcontrib>Liu, Yan-Ping</creatorcontrib><creatorcontrib>Wang, Jian-Feng</creatorcontrib><creatorcontrib>Li, Bin</creatorcontrib><creatorcontrib>Li, Xin</creatorcontrib><creatorcontrib>Ji, Yun-Run</creatorcontrib><creatorcontrib>Zhou, Dong-Mei</creatorcontrib><creatorcontrib>Xu, Rong</creatorcontrib><creatorcontrib>Wang, Si-Nong</creatorcontrib><creatorcontrib>Zhou, Meng</creatorcontrib><creatorcontrib>Zhang, Hong-Ya</creatorcontrib><creatorcontrib>Zhang, Cang</creatorcontrib><creatorcontrib>Li, Su</creatorcontrib><creatorcontrib>Wang, Rui-Ping</creatorcontrib><title>Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial</title><title>Evidence-based complementary and alternative medicine</title><addtitle>Evid Based Complement Alternat Med</addtitle><description>Introduction. The etiology and pathogenesis of psoriasis are complex. Blood-heat syndrome is the core pathogenesis of psoriasis. Based on theories of Chinese medicine (CM), heat-clearing and blood-cooling (HCBC) are the primary treatment. Very few studies have investigated the pharmacological mechanism of the CM HCBC method for treating psoriasis. This multicenter randomized controlled trial will focus on treating psoriasis blood-heat syndrome with the HCBC method using Jueyin granules (JYKL). This will be an objective and standardized evaluation of the efficacy, safety, and reproducibility of the HCBC method to obtain objective evidence meeting international standards that aim to establish a clinical standard suitable for the popular application of CM for treating psoriasis. Methods and Analysis. A five-center randomized double-blind placebo-controlled clinical design will be used in this study. At least 196 participants will be randomly assigned to receive either JYKL or placebo treatment approximately 30 minutes after meals in the morning and evening (one sachet per time, twice daily for 8 consecutive weeks). The study duration will be 17 weeks, including 1 week of screening, 8 weeks of intervention, and 8 weeks of follow-up. The patients will be evaluated every 2 weeks, and the measures will be compared with baseline values. The primary outcome measure will be the psoriasis lesion area severity index. We will also observe the recurrence rate, body surface area, physician global assessment, dermatology life quality index, quality of life index, visual analogue scale score, CM symptom score, combined drug use, and adverse events. This trial is registered with NCT03961230.</description><subject>Analysis</subject><subject>Blood</subject><subject>Care and treatment</subject><subject>Chinese medicine</subject><subject>Clinical trials</subject><subject>Dermatology</subject><subject>Etiology</subject><subject>Evidence-based medicine</subject><subject>Family medical history</subject><subject>Heat</subject><subject>International standards</subject><subject>Intervention</subject><subject>Medical care</subject><subject>Patient safety</subject><subject>Patients</subject><subject>Psoriasis</subject><subject>Psoriasis vulgaris</subject><subject>Quality management</subject><subject>Quality of life</subject><subject>Skin</subject><subject>Substance abuse treatment</subject><issn>1741-427X</issn><issn>1741-4288</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>RHX</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqNks1u1DAURiMEoqWwY40ssUGCUNuJ47gLpGpUCqgjRlAQO-vGPzOuPHGxE6rhWXhYHGaYAitWtuzjc--1vqJ4TPBLQhg7ppji41bUtMLkTnFIeE3Kmrbt3f2efzkoHqR0hTEVnPP7xUFFK0YaLA6LH2fWOgVqg6DX6CNYM2xQsOjdaDauR-cR-tGbhGyIaAGDM_2Q0I0bVmjuvC6HUM6DNhEGgxYpRAfJJfR59EuILp2gRQxDUMH_eg9oPvrBqewwEX3IBcPafTcaLTwo04VyFvohBu_z0WVW-YfFPQs-mUe79aj49PrscvamvHh__nZ2elGqWoih5Mp2Vrek0YrQqrGWMg0Kg6B5ERwwYE0bplvdtZ2uGK845ayzjWqMMLSrjopXW-_12K2NnhqM4OV1dGuIGxnAyb9vereSy_BNcsJJQ9sseLYTxPB1NGmQa5eU8R56E8YkaSWalon87Rl9-g96FcbY5_EmirSMYV7fUkvwRrrehlxXTVJ52tBacFpjmqkXW0rFkFI0dt8ywXIKh5zCIXfhyPiTP8fcw7_TkIHnW2Dleg037j91JjPGwi1NWEs5rn4CYl_ODA</recordid><startdate>2020</startdate><enddate>2020</enddate><creator>Lv, Jing-Jing</creator><creator>Yin, Qing-Feng</creator><creator>Li, Wei</creator><creator>Liu, Yan-Ping</creator><creator>Wang, Jian-Feng</creator><creator>Li, Bin</creator><creator>Li, Xin</creator><creator>Ji, Yun-Run</creator><creator>Zhou, Dong-Mei</creator><creator>Xu, Rong</creator><creator>Wang, Si-Nong</creator><creator>Zhou, Meng</creator><creator>Zhang, Hong-Ya</creator><creator>Zhang, Cang</creator><creator>Li, Su</creator><creator>Wang, Rui-Ping</creator><general>Hindawi Publishing Corporation</general><general>Hindawi</general><general>John Wiley & Sons, Inc</general><general>Hindawi 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and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial</title><author>Lv, Jing-Jing ; Yin, Qing-Feng ; Li, Wei ; Liu, Yan-Ping ; Wang, Jian-Feng ; Li, Bin ; Li, Xin ; Ji, Yun-Run ; Zhou, Dong-Mei ; Xu, Rong ; Wang, Si-Nong ; Zhou, Meng ; Zhang, Hong-Ya ; Zhang, Cang ; Li, Su ; Wang, Rui-Ping</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c499t-7cfbfd816dc1236ff25dac0a92dac97a0a0d265d8db8bd35737275bf6c6e9e2b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Analysis</topic><topic>Blood</topic><topic>Care and treatment</topic><topic>Chinese medicine</topic><topic>Clinical trials</topic><topic>Dermatology</topic><topic>Etiology</topic><topic>Evidence-based medicine</topic><topic>Family medical history</topic><topic>Heat</topic><topic>International standards</topic><topic>Intervention</topic><topic>Medical care</topic><topic>Patient safety</topic><topic>Patients</topic><topic>Psoriasis</topic><topic>Psoriasis vulgaris</topic><topic>Quality management</topic><topic>Quality of life</topic><topic>Skin</topic><topic>Substance abuse treatment</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lv, Jing-Jing</creatorcontrib><creatorcontrib>Yin, Qing-Feng</creatorcontrib><creatorcontrib>Li, Wei</creatorcontrib><creatorcontrib>Liu, Yan-Ping</creatorcontrib><creatorcontrib>Wang, Jian-Feng</creatorcontrib><creatorcontrib>Li, Bin</creatorcontrib><creatorcontrib>Li, Xin</creatorcontrib><creatorcontrib>Ji, Yun-Run</creatorcontrib><creatorcontrib>Zhou, Dong-Mei</creatorcontrib><creatorcontrib>Xu, Rong</creatorcontrib><creatorcontrib>Wang, Si-Nong</creatorcontrib><creatorcontrib>Zhou, Meng</creatorcontrib><creatorcontrib>Zhang, Hong-Ya</creatorcontrib><creatorcontrib>Zhang, 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Qing-Feng</au><au>Li, Wei</au><au>Liu, Yan-Ping</au><au>Wang, Jian-Feng</au><au>Li, Bin</au><au>Li, Xin</au><au>Ji, Yun-Run</au><au>Zhou, Dong-Mei</au><au>Xu, Rong</au><au>Wang, Si-Nong</au><au>Zhou, Meng</au><au>Zhang, Hong-Ya</au><au>Zhang, Cang</au><au>Li, Su</au><au>Wang, Rui-Ping</au><au>Sherman, Ronald</au><au>Ronald Sherman</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial</atitle><jtitle>Evidence-based complementary and alternative medicine</jtitle><addtitle>Evid Based Complement Alternat Med</addtitle><date>2020</date><risdate>2020</risdate><volume>2020</volume><issue>2020</issue><spage>1</spage><epage>9</epage><pages>1-9</pages><issn>1741-427X</issn><eissn>1741-4288</eissn><abstract>Introduction. The etiology and pathogenesis of psoriasis are complex. Blood-heat syndrome is the core pathogenesis of psoriasis. Based on theories of Chinese medicine (CM), heat-clearing and blood-cooling (HCBC) are the primary treatment. Very few studies have investigated the pharmacological mechanism of the CM HCBC method for treating psoriasis. This multicenter randomized controlled trial will focus on treating psoriasis blood-heat syndrome with the HCBC method using Jueyin granules (JYKL). This will be an objective and standardized evaluation of the efficacy, safety, and reproducibility of the HCBC method to obtain objective evidence meeting international standards that aim to establish a clinical standard suitable for the popular application of CM for treating psoriasis. Methods and Analysis. A five-center randomized double-blind placebo-controlled clinical design will be used in this study. At least 196 participants will be randomly assigned to receive either JYKL or placebo treatment approximately 30 minutes after meals in the morning and evening (one sachet per time, twice daily for 8 consecutive weeks). The study duration will be 17 weeks, including 1 week of screening, 8 weeks of intervention, and 8 weeks of follow-up. The patients will be evaluated every 2 weeks, and the measures will be compared with baseline values. The primary outcome measure will be the psoriasis lesion area severity index. We will also observe the recurrence rate, body surface area, physician global assessment, dermatology life quality index, quality of life index, visual analogue scale score, CM symptom score, combined drug use, and adverse events. This trial is registered with NCT03961230.</abstract><cop>Cairo, Egypt</cop><pub>Hindawi Publishing Corporation</pub><pmid>32351609</pmid><doi>10.1155/2020/8942301</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-8607-8874</orcidid><orcidid>https://orcid.org/0000-0003-2525-9679</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Analysis Blood Care and treatment Chinese medicine Clinical trials Dermatology Etiology Evidence-based medicine Family medical history Heat International standards Intervention Medical care Patient safety Patients Psoriasis Psoriasis vulgaris Quality management Quality of life Skin Substance abuse treatment |
title | Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial |
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