Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham and University of Milan has jointly received funding from Department of Science and Technology, Government of India and Ministero Degli Affari Esterie Della Cooperazione Internazionale, Italy (Ministry of Foreign Affairs, Italy) for researcher exchange program for a duration of three years from 2017- 2019.

The principal investigators of the project are Dr. P. Ram Manohar, Research Director, Amrita School of Ayurveda from the Indian side and Prof. Antonella Delle Fave, Department of Pathophysiology and Transplantation, University of Milan, Italy. The co- investigators are Dr. Anantharam Sharma, Amrita School of Ayurveda, India and Prof. Nereo Bresolin, Neurologist, University of Milan, Italy.

The collaboration between Amrita School of Ayurveda at Amrita Vishwa Vidyapeetham and the University of Milan is based on previous contacts and joint activities between members of the two institutions who are involved in this program. The major aim of this collaborative exchange project is to design an integrated treatment protocol including standard conventional care, Ayurveda and psychological counseling addressed to patients with Duchenne Muscular Dystrophy (DMD) and Spinal Muscular Atrophy (SMA).

The possibility to test this protocol on a small group of patients in India and Italy, and the evaluation of the integrated treatment outcomes will create the basis for a randomized study in a larger cohort of patients in both countries. The joint collaboration of Italian and Indian partners could lead to the identification of an approach to healthcare capitalizing on local strengths and resources and based on the integration of different knowledge systems and disciplinary perspectives. This synergy could possibly lead to improvements in healthcare services and treatments available to patients with neuromuscular diseases in both countries, and it could pave the way to further joint projects addressed to other kinds of pathologies.

The exchange program will include different phases. In the first year, the partner meetings at the two sites will be devoted to reciprocal exchange of information about the diagnostic, clinical and therapeutic strategies adopted in the two centers to treat DMD and SMA. This will allow to compare patterns of disease prevalence, progression, and standard care approaches in the two countries. Updates on the pre-clinical and clinical research lines conducted in the two institutions, concerning both conventional and Ayurvedic approaches to disease identification and treatment, will be discussed. Potentials for designing joint research avenues will be explored, including genetic studies, preclinical in-vivo and in-vitro studies, clinical trials, and psychosocial interventions based on both Ayurveda and conventional approaches will be taken into account. A list of joint activities will be defined for the next two years. In the second year, the collaborative program will be operationalized through research and intervention studies. In particular, the safety and efficacy of the association of Ayurvedic medicine to conventional therapy will be tested in a small group of patients with DMD and SMA both in Italy and in India, and locally compared with groups of patients undergoing conventional treatment only. The efficacy of the integrated approach will be evaluated through motor function scales; measures of cardiac, respiratory and other vital functions, differentiated according to the specific clinical features and progression of each disease; measures of mental health and well-being indicators. The same treatment strategies and evaluation protocol will be used in the two centers. The duration of the clinical study will be 12 months, with measurements performed on both experimental and control groups at baseline (T0), after 6 months (T6), at the end of the study (T12), and as follow up evaluation 6 months after the study conclusion (T18). In the third year, the data will be analysed in order to detect potential improvements in motor function, perceived well-being, mental health and quality of life, as well as respiratory, cardiac and other vital functions in all experimental and control groups and between countries. It will be possible to detect pre-post changes in each of the treated groups compared to the respective control groups. Similarities and differences in these changes will be discussed and interpreted. The study results will be reported in joint scientific publications and they will pave the way for further collaborative studies with larger samples of participants and addressing other typologies of neuromuscular diseases. Besides reciprocal visits, throughout the three-year program teleconferences will be regularly held among the partners, in order to define and set up contents and schedule of the visits, monitor project development and progressively evaluate outcomes at the two sites.

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