• Users Online: 116
  • Home
  • Print this page
  • Email this page
Home About us Editorial board Ahead of print Current issue Search Archives Submit article Instructions Subscribe Contacts Login 
ORIGINAL ARTICLE
Year : 2022  |  Volume : 8  |  Issue : 1  |  Page : 44-51

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


1 Department of Pharmacology, Government Medical College, Vellore, Tamil Nadu, India
2 Department of Orthopedics, Government Medical College, Vellore, Tamil Nadu, India
3 Department of Pharmacology, Sri Venkateswaraa Medical College Hospital and Research Centre, Puducherry, India
4 Department of Pharmacology, Pondicherry Institute of Medical Sciences, Puducherry, India
5 Medical Advisor, Ki3, Clinical Research Organisation, Chrompet, Chennai, Tamil Nadu, India
6 Managing Director, Microcore Research Lab India Pvt. Ltd., Erode, Tamil Nadu, India
7 Executive Director, Microcore Research Lab India Pvt. Ltd., Erode, Tamil Nadu, India

Correspondence Address:
Dr. B Aravinda Kumar
Department of Pharmacology, Pondicherry Institute of Medical Sciences, Puducherry - 605 014
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jcrsm.jcrsm_21_22

Rights and Permissions

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.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed389    
    Printed24    
    Emailed0    
    PDF Downloaded69    
    Comments [Add]    

Recommend this journal