Collaborative clinical research projects in the m
anagement of Dengue, pre diabetic subjects and Type-2 Diabetes Mellitus and inauguration of Investigators’ training programme Launched by Vaidya Rajesh Kotecha, Secretary, Ministry of AYUSH, Govt. of India Facilitated by: Prof. Vaidya K. S. Dhiman, Director General, CCRAS at KLE Centenary Convention Center KLE University Campus, Belagavi.
List of Research studies being launched at a glance
Evaluation of Add on Efficacy & Safety of An Ayurvedic Formulation in the Management of Dengue Fever & Prevention of its complications– A Double Blind Clinical Study
A Randomized Placebo Controlled Prospective Phase II Clinical Study of an Ayurvedic coded drug 'Ayush D' on Glycemic control in Prediabetic Subjects”
A Randomized placebo controlled phase-II clinical study of an Ayurvedic coded drug ‘AYUSH – D’ in the management of Type 2-Diabetes Mellitus as add on therapy to Metformin
Pharmaco-epidemiological studies for clinical safety and effectiveness of Ayurvedic medicine.
Knowledge, attitude, and practice towards Ayurvedic medicine use among the Diabetics a cross-sectional study.
Impact of diet and lifestyle on Rheumatoid Arthritis- a cross sectional study.
Consumer perception about Ayurvedic treatment- a web based survey of Indian population.
Online survey of pain management practices among Ayurveda practitioners with special reference to osteoarthritis.
Awareness about Neuropsychiatric disorders among Ayurvedic doctors- KAP STUDY
Dengue is emerging as a major health problem in tropical countries and is drawing the attention of Government and all health agencies due to its fatality and limitations of treatment in conventional system. Currently, it is becoming endemic throughout the country and in certain places like Belagavi it occurs throughout the year. There is a hope from Ayurveda to provide an alternative treatment which can improve platelet count, minimizing the effect of infection, general condition of the patients so as to reduce fatality/complications.
Worldwide, an estimated 150 million people are affected by diabetes and the number is likely to reach at least 300 million by the year 2025 if successful strategies are not implemented for its prevention and control. By 2025, approximately 75% of all persons with diabetes will live in developing countries. Moreover, Type-2 diabetes, the most common form, is affecting even-younger age groups, striking young adults and even adolescents. DM is fast gaining the status of a potential epidemic in India with more than 62 million diabetic individuals currently diagnosed with the disease. To reduce the burden of diseases, it is essential to screen pre diabetic subjects and to minimize the risk of Type-2 diabetes mellitus.
Several policy documents such as National Health Policies, National Health Mission (NHM) Government of India (GoI) recommend for mainstreaming of traditional systems in health care delivery systems at all levels in the country. The National Health Policy Document 2017 envisages the attainment of the highest possible level of health and well being for all at all ages through a preventive and promotive healthcare. Specific quantitative goals lay emphasis to reduce the premature mortality from Diabetes by 25% by 2025.
To take forward the research in Ayurveda, the Government of India has setup Central Council for Research in Ayurvedic Sciences (CCRAS), an apex autonomous body under Ministry of AYUSH, Govt. of India for undertaking, coordinating, formulating, developing and promoting research on scientific lines in Ayurvedic Sciences.
Considering the burden of Diabetes Mellitus and emerging crisis in Dengue management, the Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of AYUSH, Government of India has undertaken the drug development systematically through standardization studies for quality assurance and pre-clinical safety studies of 2 Ayurvedic coded drug viz. Ayush PJ-7 for Dengue and Ayush D for Prediabetic subjects & Type 2 Diabetes Mellitus. The ingredients of formulation for AYUSH PJ-7 were selected rationally with potential leads from the classical Ayurvedic literatures backed by scientific evidence for Dengue. After meeting the pre-requisite of clinical trial, CCRAS and Indian Council of Medical Research (ICMR) developed a clinical protocol to evaluate the efficacy of AYUSH PJ-7 in the management of Dengue fever and prevention of its complications through placebo controlled double blind randomized clinical trial. This study is being conducted involving 3 institutes at Belagavi i.e. KLEU’s Shri BMK Ayurveda Mahavidyalaya, Belagavi, KLE University’s, JN Medical College, National Institute of Traditional Medicine (Formerly Regional Medical Research Centre RMRC) ICMR, Belagavi.
The council has undertaken the drug development of AYUSH D taking leads from Local Health traditions through systematic process of drug development. Now two multicentre double blind randomized placebo controlled clinical trials are being taken up in pre diabetic subjects and Type-2 Diabetes Mellitus involving 5 collaborating institutes viz. AIIMS, New Delhi; R.A. Podar Ayurved Medical College, Mumbai; Sri BMK Ayurveda Mahavidyalaya, Belagavi, Karnataka, R.G. Govt. P.G. Ayurveda College Paprola and Regional Ayurveda Research Institute for Metabolic Disorders, Bengaluru.
To document the effectiveness and safety of Ayurveda interventions, the CCRAS is also launching a multi centre pharmacoepidemiology study of Ayurveda interventions initially at all its clinical research facilities in the country. The data will certainly help to understand the gross effectiveness and safety of different intervention among different populations at different geographical regions across the country and record the use of Ayurveda interventions specially herbo-mineral formulations. This would also serve as National data for sharing with international communities for recognition of Ayurveda drugs across the globe.
CCRAS, Ministry of AYUSH, Govt. of India also intends to generate data on understanding perception and utilization of different specialities and strengths of Ayurveda among physicians, students of medical sciences and general public and consumers etc. and launching 5 projects on pain management, diabetes mellitus, Rheumatoid Arthritis, Neuropsychiatric disorders. This data is essential to assess the ground situation regarding utilization of Ayurveda among all concerned and forms a base line for health administrators and policy makers.
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