[논문]Efficacy and safety of ChondroT on knee-osteoarthritis : Protocol for a 8-week, randomized, double-blind, placebo-controlled, multicenter therapeutic exploratory clinical trial

Lee, Sangkwan; Kim, Seon-jong

doi:10.1097/MD.0000000000010170

Efficacy and safety of ChondroT on knee-osteoarthritis : Protocol for a 8-week, randomized, double-blind, placebo-controlled, multicenter therapeutic exploratory clinical trial 원문보기

Medicine, v.97 no.12, 2018년, pp.e0170 -

Lee, Sangkwan (College of Korean Medicine, Wonkwang University, Iksandae-ro, Iksan, Jeonbuk, Republic of Korea) , Kim, Seon-jong (College of Korean Medicine, Dongshin University, Geonjae-ro, Naju, Jeollanam-do, Republic of Korea.)

Abstract ▼ AI-Helper

AbstractBackground:Arthritis is the most common disease in elderly individuals. Many medications for osteoarthritis treatment have the potential for side effects. Using a bioinformatics tool and preclinical studies, ChondroT, 5 herbal complexes, was identified from Ganghwaljetongyeum, which is a18 herbal complex, which has often used to treat osteoarthritis. The goal of this study is to evaluate short-term safety of ChondroT.Methods:This will be a multicenter, randomized, double-blind, and placebo-controlled trial. There will be a 2-week run-in period before random allocation to 3 groups, ChondroT 1.0 g, 2.0 g, and placebo groups. Total duration of the clinical trial will be 14 weeks including a 4-week washout follow-up. Participants will be followed-up every 4 weeks, and the effect and the safety will be assessed at visit 2, 3, and 4. All participants are asked to maintain the medication schedule in this protocol. The primary outcome will be measured using pain visual analog scale (VAS) after 8 week treatment and secondary outcomes will include pain VAS score after 4 week treatment, SF-36 survey score, patient's global assessment, physical function test, and the change of erythrocyte sedimentation rate, and C-reactive protein. The repeated-measure analysis will be used for the primary efficacy based on full analysis set and per-protocol.Discussion:This study has restrictive inclusion, exclusion criteria, and a well-controlled intervention, and it will be the first randomized controlled trial to evaluate the efficacy and safety of ChondroT formula in osteoarthritis patients. The trial according to this protocol may provide a new intervention in the treatment of osteoarthritis.

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[1] Wolters Kluwer Health/Lippincott Williams & Wilkins , Porth CM Essentials of Pathophysiology: Concepts of Altered Health States . 3rd edition 2011 .
[2] Whelton A Hamilton CW Nonsteroidal anti-inflammatory drugs: effects on kidney function . J Clin Pharmacol 1991 ; 31 : 588 – 98 . 1894754

상세보기
[3] Buchman AL Side effects of corticosteroid therapy . J Clin Gastroenterol 2001 ; 33 : 289 – 94 . 11588541

상세보기
[4] O’Dell JR Mikuls TR Taylor TH Therapies for active rheumatoid arthritis after methotrexate failure . N Engl J Med 2013 ; 369 : 307 – 18 . 23755969

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[5] Jeoung BR Lee KD Na CS Ganghwaljetongyeum, an anti-arthritic remedy, attenuates synoviocyte proliferation and reduces the production of proinflammatory mediators in macrophages: the therapeutic effect of GHJTY on rheumatoid arthritis . BMC Complement Altern Med 2013 ; 13 : 47 . 23442977
[6] Choi W Choi C-H Kim YR HerDing: herb recommendation system to treat diseases using genes and chemicals . Database 2016 ; 2016 : baw011 . 26980517

상세보기
[7] Park JU Kim S-J Na C-S Chondroprotective and anti-inflammatory effects of ChondroT, a new complex herbal medication . BMC Complement Altern Med 2016 ; 16 : 213 . 27411719

상세보기
[8] Altman R Asch E Bloch D Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association . Arthritis Rheum 1986 ; 29 : 1039 – 49 . 3741515
[9] Han C-W Lee E-J Iwaya T Development of the Korean version of Short-Form 36-Item Health Survey: health related QOL of healthy elderly people and elderly patients in Korea . Tohoku J Exp Med 2004 ; 203 : 189 – 94 . 15240928

상세보기
[10] Bae SC Lee HS Yun HR Cross-cultural adaptation and validation of Korean Western Ontario and McMaster Universities (WOMAC) and Lequesne osteoarthritis indices for clinical research . Osteoarthritis Cartilage 2001 ; 9 : 746 – 50 . 11795994

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Efficacy and safety of ChondroT on knee-osteoarthritis : Protocol for a 8-week, randomized, double-blind, placebo-controlled, multicenter therapeutic exploratory clinical trial 원문보기

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Efficacy and safety of ChondroT on knee-osteoarthritis : Protocol for a 8-week, randomized, double-blind, placebo-controlled, multicenter therapeutic exploratory clinical trial 원문보기

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