A randomized, open-label, multicentered parallel-group clinical study to evaluate the efficacy and safety of Joint Core™ compared to Jointace DN™ in osteoarthritis patients
Background: Osteoarthritis (OA) is one of the most common musculoskeletal diseases worldwide, with pain, joint stiffness, fatigue associated with disability, and loss of physical activity. There is a need for an effective and safer alternative medication for the management of OA knee in elderly pati...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2022-01-01
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| Series: | Journal of Current Research in Scientific Medicine |
| Subjects: | |
| Online Access: | http://www.jcrsmed.org/article.asp?issn=2455-3069;year=2022;volume=8;issue=1;spage=44;epage=51;aulast=Kannan |
| _version_ | 1811309636543840256 |
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| author | Ramesh Kannan Sriram Bakthavatchalam Sakthibalan Murugesan B Aravinda Kumar Bijoy Deb Chandramohan Marimuthu Priya Rajendran |
| author_facet | Ramesh Kannan Sriram Bakthavatchalam Sakthibalan Murugesan B Aravinda Kumar Bijoy Deb Chandramohan Marimuthu Priya Rajendran |
| author_sort | Ramesh Kannan |
| collection | DOAJ |
| description | Background: Osteoarthritis (OA) is one of the most common musculoskeletal diseases worldwide, with pain, joint stiffness, fatigue associated with disability, and loss of physical activity. There is a need for an effective and safer alternative medication for the management of OA knee in elderly patients as the current medications possess severe risks to the patient compromising the quality of life.
Methodology: The study design and setting were phase 3, randomized, open-label, multicentered, active-controlled parallel-group interventional trial conducted at secondary care centers in Puducherry. Fifty patients (50) patients with OA knee were enrolled as per study criteria and randomized to receive Joint Core™ and Jointace DN™ for 12 weeks. The outcomes were assessed using various pain scales and subscales, Short-Form Health-12 (SF-12) questionnaire, and inflammatory markers. The data obtained at baseline and weeks 4, 8, and 12 were compared and statistically analyzed.
Results: Joint Core™ showed continuous reduction in the Visual Analog Scale pain scores at 4, 8, and 12 weeks and improvement in Western Ontario and McMaster Universities OA Index subscale and pain global assessment scales and good response rate in the Outcome Measures for Rheumatology Committee and OA Research Society International Standing Committee for Clinical Trials Response Criteria Initiative scores proving it to be efficacious in the treatment of OA knee compared to Jointace DN™. The safety assessed showed that Joint Core™ produces minimal gastrointestinal side effects and does not affect any organs as assessed by the laboratory parameters.
Conclusion: Joint Core™ is effective and safe in the treatment of OA knee when compared to its comparator Jointace DN™. Joint Core™ can be an alternative treatment option in the patients with OA knee who are intolerant to diacerein-based combinations available to treat OA. |
| first_indexed | 2024-04-13T09:45:02Z |
| format | Article |
| id | doaj.art-b88b281d58c04a66a93fbd2eb6d76cfe |
| institution | Directory Open Access Journal |
| issn | 2455-3069 |
| language | English |
| last_indexed | 2024-04-13T09:45:02Z |
| publishDate | 2022-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Journal of Current Research in Scientific Medicine |
| spelling | doaj.art-b88b281d58c04a66a93fbd2eb6d76cfe2022-12-22T02:51:47ZengWolters Kluwer Medknow PublicationsJournal of Current Research in Scientific Medicine2455-30692022-01-0181445110.4103/jcrsm.jcrsm_21_22A randomized, open-label, multicentered parallel-group clinical study to evaluate the efficacy and safety of Joint Core™ compared to Jointace DN™ in osteoarthritis patientsRamesh KannanSriram BakthavatchalamSakthibalan MurugesanB Aravinda KumarBijoy DebChandramohan MarimuthuPriya RajendranBackground: Osteoarthritis (OA) is one of the most common musculoskeletal diseases worldwide, with pain, joint stiffness, fatigue associated with disability, and loss of physical activity. There is a need for an effective and safer alternative medication for the management of OA knee in elderly patients as the current medications possess severe risks to the patient compromising the quality of life. Methodology: The study design and setting were phase 3, randomized, open-label, multicentered, active-controlled parallel-group interventional trial conducted at secondary care centers in Puducherry. Fifty patients (50) patients with OA knee were enrolled as per study criteria and randomized to receive Joint Core™ and Jointace DN™ for 12 weeks. The outcomes were assessed using various pain scales and subscales, Short-Form Health-12 (SF-12) questionnaire, and inflammatory markers. The data obtained at baseline and weeks 4, 8, and 12 were compared and statistically analyzed. Results: Joint Core™ showed continuous reduction in the Visual Analog Scale pain scores at 4, 8, and 12 weeks and improvement in Western Ontario and McMaster Universities OA Index subscale and pain global assessment scales and good response rate in the Outcome Measures for Rheumatology Committee and OA Research Society International Standing Committee for Clinical Trials Response Criteria Initiative scores proving it to be efficacious in the treatment of OA knee compared to Jointace DN™. The safety assessed showed that Joint Core™ produces minimal gastrointestinal side effects and does not affect any organs as assessed by the laboratory parameters. Conclusion: Joint Core™ is effective and safe in the treatment of OA knee when compared to its comparator Jointace DN™. Joint Core™ can be an alternative treatment option in the patients with OA knee who are intolerant to diacerein-based combinations available to treat OA.http://www.jcrsmed.org/article.asp?issn=2455-3069;year=2022;volume=8;issue=1;spage=44;epage=51;aulast=Kannananti-inflammatory agentscurcumineggshell membrane boswellia serrataosteoarthritis knee |
| spellingShingle | Ramesh Kannan Sriram Bakthavatchalam Sakthibalan Murugesan B Aravinda Kumar Bijoy Deb Chandramohan Marimuthu Priya Rajendran A randomized, open-label, multicentered parallel-group clinical study to evaluate the efficacy and safety of Joint Core™ compared to Jointace DN™ in osteoarthritis patients Journal of Current Research in Scientific Medicine anti-inflammatory agents curcumin eggshell membrane boswellia serrata osteoarthritis knee |
| title | A randomized, open-label, multicentered parallel-group clinical study to evaluate the efficacy and safety of Joint Core™ compared to Jointace DN™ in osteoarthritis patients |
| title_full | A randomized, open-label, multicentered parallel-group clinical study to evaluate the efficacy and safety of Joint Core™ compared to Jointace DN™ in osteoarthritis patients |
| title_fullStr | A randomized, open-label, multicentered parallel-group clinical study to evaluate the efficacy and safety of Joint Core™ compared to Jointace DN™ in osteoarthritis patients |
| title_full_unstemmed | A randomized, open-label, multicentered parallel-group clinical study to evaluate the efficacy and safety of Joint Core™ compared to Jointace DN™ in osteoarthritis patients |
| title_short | A randomized, open-label, multicentered parallel-group clinical study to evaluate the efficacy and safety of Joint Core™ compared to Jointace DN™ in osteoarthritis patients |
| title_sort | randomized open label multicentered parallel group clinical study to evaluate the efficacy and safety of joint core™ compared to jointace dn™ in osteoarthritis patients |
| topic | anti-inflammatory agents curcumin eggshell membrane boswellia serrata osteoarthritis knee |
| url | http://www.jcrsmed.org/article.asp?issn=2455-3069;year=2022;volume=8;issue=1;spage=44;epage=51;aulast=Kannan |
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