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A Collaborative Project of Uttarakhand Council of Science and Technology (UCOST) and Vaidya Chandra Prakash Cancer Research Foundation (VCPCRF), Dehradun, Uttarakhand, India Opportunity India is the only country in the world where different systems of medicines like Ayurveda, Unani, Siddha, Homeopathy and Naturopathy are officially recognized as independent medical systems in conjunction with western medicine (allopath). Opportunity- II A registered physician of Ayurveda and Unani can prepare medicines for the use in his own clinical practice without obtaining manufacturing license Integrated system of education and research Blending of modern diagnostics with traditional knowledge Scope of documentation (GCP guidelines) Positivism: A Scientific Approach Observation Drug Discovery 15 years $1.8 billion Hypothesis Penicillin Nitrous Oxide Theory Discovery & Development of Nitrous Oxide and Penicillin Acute Promyelocytic Leukemia : Model Studied Under GOI(1997-2000) Observation Preliminary Study: Sorting out of patients of APML Pilot Study: 1. Bone marrow aspiration peripheral blood smear measurement 2. Liver and kidney function test for toxicological evaluation Hypothesis Can silver based compound be effective for treating APML Patients? Methodology 1. Standardization of raw material 2. Development of in-process quality control technique 3. Standardization of finished products 4. Toxicological studies 5. Effective dose studies 6. Human trials Acute Promyelocytic Leukemia Model Studied (Outcome and Current Scenario) US and European patent 191708 dated 08/23/1999 through NDRC, Govt. of India Padamashri by President of India 1999 Prakash et al. 2010. Herbo-mineral ayurvedic treatment in a high risk acute promyelocytic leukemia patient with second relapse: 12 years follow up J-AIM, 1, (3): 215-218 Limited availability of treatment… Waste of time, resources and efforts… Revisiting the Rationality: Partnership with UCOST Theme: Chronic Pancreatitis What is Chronic Pancreatitis? Chronic Pancreatitis (CP) is a progressive inflammatory disease of the Pancreas Irreversible morphological changes Primary symptoms- recurrent abdominal and back pain, indigestion , nausea , vomiting , steatorrhorea with weight loss Mild elevation of Serum Amylase and Lipase Diagnostics: X-Ray, Ultra Sound, CT Scan, ERCP & MRCP What is the cause of CP? Heavy and prolonged use of alcohol (Though only 3% alcoholic develop CP) Smoking, high fat diet and stress Commonly used etiological classification: TIGAR-O T- Toxins I- Idiopathic G- Genetic A- Auto immune R- Recurrent O -Obstructive Tropical CP – India, Africa and South America Prevalence and impact of CP Worldwide increasing incidence 1.6 to 23/1,00,000. South India 114/1,00,000 Rising cost of hospitalization and medicines 340 million dollar annual sale of Creon (Pancrelipase) (Source: Abbot Pharmaceuticals 2011) Six more brands* available in global market. Total annual sale > one billion US Dollar 32% mortality (104 months follow up) Progression to fibrosis, Pancreatic ascitis and cancer *Pancreaze, Pertzye, Ultresa,Viokace, Zenpep and Lipancreatin Conventional Treatment of CP Life long enzymes Periodical Emergency hospitalisation – IV fluids, painkillers, anti-inflammatory, enzymes and antibiotic ERCP stenting Surgical intervention It involves high cost, side effects and in many case progression of disease Ayurvedic Treatment for CP Single mineral complex in a daily dose of 125 mg three times a day with high protein diet One year duration Effects start from the day one and remain sustainable Astonishing success stories with no side effects End product is devoid of free metals In house animal studies – No Grade II toxicity Future Direction Need of R & D to ascertain: - Reproducibly, Characterisation - Experimental & clinical studies Continuity of treatment through Speciality Ayurvedic Clinics (SAC) in India; presently at Dehradun and Kolkata Systematic development of NEW CLINICAL ENTITY (NCE) Availability within India and other countries following the regulations Current Scenario Strong evidence of clinical efficacy (over 30 years of experience) Rich traditional literature Scientific and technological inputs Raw material and manpower Need of the society Regulations and resources….. Highlights of the Project (7 years) Standardization of raw material Development of in process quality control technique Standardization of finished products Toxicological Evaluation Effective dose studies Human trials Three Years Two Years Two Years Proposed Partners IIT Roorkee, Uttarakhand Wadia Institute of Himalayan Studies, Dehradun Uttarakhand Medical University, Srinagar Paramedical and Medical Institutes of Uttarakhand Budgetary Requirement 1st Year 2nd Year 3rd 4th Year Year Amount in Rs. 94.25 68.15 70.50 70.00 lacs 5th Year 6th Year 7th Year 100.00 57.50 47.50 A total of Rs. Five Crore Seven Lacs Ninety Thousand will be required in seven years limited period Benefits Innovation in the treatment of Chronic Pancreatitis from Uttarakhand Big boost to scientific Ayurveda Substantial savings of resources and human lives Forex earning and revenue generation Pride to State, Country and Ayurveda Need SALVO ACTION All power is within you. You can do anything and everything. Believe in that. Do not believe that you are weak; do not believe that you are half-crazy lunatics, as most of us do nowadays. Stand up and express the divinity within you. - Swami Vivekanada