4 research outputs found

    Undenatured collagen type II for the treatment of osteoarthritis: a review

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    Osteoarthritis is a prevalent musculoskeletal condition worldwide with rising rates in elderly people. Both mechanical and immunological factors are implicated in the pathogenesis of osteoarthritis resulting in destruction of the articular cartilage. Non-steroidal anti-inflammatory drugs (NSAIDs) commonly used for the treatment of osteoarthritis, are associated with several adverse events and also do not affect the underlying disease process. Clinicians and patients both seek options which are safe and effective in the treatment of osteoarthritis. Collagen derivatives represent a suitable option in such cases. Collagen is the most abundant component of the cartilage. Collage derivatives have shown to have disease modifying action in osteoarthritis. Depending on the degree of hydrolysis and molecular weight, collage derivatives are classified into undenaured collagen, gelatin and collage hydrolysate. Collagen derivatives are well tolerated without major safety concerns. Undenatured type II collagen has shown to provide significant improvement in patients with osteoarthritis. In this article we discuss, the pathophysiology of osteoarthritis with focus on immunological factors and evidence for the use of undenatured collagen type II in osteoarthritis.

    A study to assess completeness of project application forms submitted to Institutional Ethics Committees (IEC) of a tertiary care hospital

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    Objectives: To review Ethics Committee (EC) application forms and to find out similarities and differences in content of five ECs forms in India. Materials and Methods: The completeness of EC application forms was assessed on the following themes: title, study team, sponsor responsibility, scientific aspects, patient safety, regulatory permissions, Informed consent process from 2008-2009. Application forms (available online) of 5 ECs were studied and compared. Results: A total of 445 application forms were analyzed, 382 were academic, 63 were sponsored. The common deficiencies in academic studies were inappropriate titles (25.13%), lack of budget details (90%). More than 95% studies had not mentioned the method of recruitment. The issue of vulnerability was not marked in more than 50% of studies. Compensation for participation/injury was poorly stated in academic (99%) studies. Among industry sponsored studies, 98% were compliant with regulatory permissions and 41% were CTRI registered. The information pertaining to Informed Consent was mentioned in all forms. Comparative analysis of application forms of 5 ECs showed that the requirements for submission were similar except 1-2 ECs asked for additional information like percentage of time allotted by investigator for studies, GCP training of study team, certification by investigator regarding accuracy of local versions of Informed consent. Conclusion: Our study recommends that increased awareness and vigilance by investigators of academic studies regarding submission of applications to EC will increase efficiency and speed of review process. A common application form for all ECs across India would be an important step to achieve uniformity in functioning of ethics committees
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