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Corallocarpus Epigaeus PRECLINICAL SAFETY EVALUATION OF “AAGASAGARUDAN KIZHANGU CHOORANAM” The dissertation Submitted by Dr. V.M. KARTHIC M.D(S) Under the Guidance of Dr. S. MURUGESAN M.D(S) Lecturer and Guide, Department of Nanju Noolum Maruthuva Neethi Noolum, National Institute of Siddha, Ch-47. Dissertation Submitted to THE TAMILNADU DR. M.G.R. MEDICAL UNIVERSITY, CHENNAI – 32 For the partial fulfillment of the requirements to the Degree of DOCTOR OF MEDICINE (SIDDHA) BRANCH-VI - DEPARTMENT OF NANJU NOOLUM MARUTHUVA NEETHI NOOLUM 2015 – 2018 NATIONAL INSTITUTE OF SIDDHA, Chennai–47 DECLARATION BY THE CANDIDATE I hereby declare that this dissertation entitled “Preclinical safety evaluation of Aagasagarudan Kizhangu Chooranam” is a bonafide and genuine research work carried out by me under the guidance of Dr.S.Murugesan, M.D(S), Guide, Department of Nanju Noolum Maruthuva Neethi Noolum, National Institute of Siddha, Chennai -47 and the dissertation has not formed the basis for the award of any Degree, Diploma, Fellowship or another similar title. Date: Signature of the Candidate Place: Chennai-47 Dr. V.M.KARTHIC BONAFIDE CERTIFICATE Certified that I have gone through the dissertation submitted by Dr.V.M.Karthic (Reg No: 321516204) a student of final year MD(S) Branch VI, Department of Nanju Noolum Maruthuva Neethi Noolum, National Institute of Siddha, Tambaram Sanatorium, Chennai – 47, and the dissertation work has been carried out by the individual only. The dissertation does not represent or reproduce the dissertation submitted or approved earlier. Place: Chennai-47 Date: Dr. S. MURUGESAN M.D(S) Dr. R. MADHAVAN M.D(S) Dept. of Nanju Noolum Maruthuva Dept. of Nanju Noolum Maruthuva Neethi Noolum, Neethi Noolum, National Institute of Siddha, National Institute of Siddha, Tambaram Sanatorium, Tambaram Sanatorium, Chennai -47. Chennai-47. Forwarded by the Head of Institution Prof. Dr.V.BANUMATHI M.D(S) Director, National Institute of Siddha, Tambaram Sanatorium, Chennai-47. ACKNOWLEDGEMENT I thank God for giving me this occasion, as long as strength and power to accomplish this obligation. I acknowledge my sincere thanks to the Secretary, Ministry of AYUSH, Health & Family welfare, New Delhi for giving great opportunity to carry out P.G and this dissertation work in National Institute of Siddha, Chennai-47 I express my sincere thanks to the Vice-chancellor, The Tamil Nadu Dr. M.G.R. Medical University, Chennai-32 I express my profound sense of gratitude to Prof. Dr. V. Banumathi, M.D(S), Director, National Institute of Siddha, Chennai- 47 for granting permission to undertake a study in this dissertation topic and also for providing all the basic facilities in order to carry out this work. I cordinally register my sincere thanks to my guide Dr. S. Murugesan M.D(S) Lecturer, Department of Nanju Noolum Maruthuva Neethi Noolum, National Institute of Siddha for his valuable guidance and encouragement in carrying out this work. I express my sincere thanks to Dr. R. RengaSundari, M.D(S), Assosiate professor, Department of Nanju Noolum Maruthuva Neethi Noolum, National Institute of Siddha, Chennai-47 for the ceaseless care and support throughout my academic period and in my work. I would like to express my sincere thanks to Dr. R. Madhavan M.D(S), Lecturer & Head of the Department.i/c, Department of Nanju Noolum Maruthuva Neethi Noolum, National Institute of Siddha, Chennai-47 for his encouragement and support to my study. I would like to express my heartfelt thanks to my Lecturer Dr.P.Shanmugapriya M.D(S), Department of Nanju Noolum Maruthuva Neethi Noolum, National Institute of Siddha, Chennai-47 for her presence and valuable guidance in my study I express my grateful to my Lecturer, Dr. V. Manjari, M.D(S), Department of Nanju Noolum Maruthuva Neethi Noolum, National Institute of Siddha, Chennai-47 for the guidance, memorable support and continuous encouragement for giving valuable suggestions to do this study. I am thankful to Dr. D. Aravind M.D(S), Associate professor, Department of Botany, National Institute of Siddha, chennai-47 for his guidance in drug authentication I extend my thanks to Dr. A. Muthuvel M.Sc, Ph.D(Biochemistry) Associate professor, National Institute of Siddha, Chennai-47 for his guidance in doing chemical studies. I am thankful to the team of Noble Research Solutions, Chennai for providing the support and genuine reports in Toxicity studies. My special acknowledgements to Mr. M. Subramanian M.Sc (Statistics), Senior Research Officer, National Institute of Siddha, Chennai- 47, for his valuable help in statistical analysis. I would like to thank Dr. V. Suba M.Pharm, Ph.D, Associate professor of Pharmacology, National Institute of Siddha, Chennai-47 for her interesting teaching of pharmacology and valuable guidance to do this study I am grateful to the assistance provided by Dr. Gayatri Natarajan M.V.Sc, Veterinarian, National Institute of Siddha, Chennai-47 in this study. I wish to dedicate this work to my wife, Dr. B. Poongodi M.D(S) for her dedicated support in every stage of this work and sacrifice for me. I thank my family members for their support in this work. I thank all my department juniors for providing their cooperation throughout the study, without whom this work will be impossible. I remind thankfully all the animals that lost their lives for the sake of my study and without which I would not have been successful in my study. CONTENTS S.NO TITLE PAGE NO 1 INTRODUCTION 1 2 AIM AND OBJECTIVES 3 3 REVIEW OF LITERATURE 4 4 MATERIALS AND METHODS 4.1 PREPRATION OF THE TEST DRUG 16 4.2 QUALITATIVE ANALYSIS 19 4.3 QUANTITATIVE ANALYSIS 27 4.4 TOXICITY STUDIES 30 5 RESULTS 5.1 QUALITATIVE ANALYSIS 37 5.2 QUANTITATIVE ANALYSIS 40 5.3 TOXICITY STUDIES 48 6 DISCUSSION 70 7 SUMMARY 73 8 CONCLUSION 75 9 BIBILIOGRAPHY 76 10 ANNEXURE 81 INTRODUCTION INTRODUCTION The Siddha system (Tamizh Maruthuvam) of medicine is the traditional medical systems in the world. The uniqueness of Siddha system is evident by its constant service to the humankind by the great Siddhar’s for more than 5000 years in combating diseases with various herbals, metals/minerals and animal products having several therapeutic indications. The Siddhar’s believes there is a divine power beyond them in achieving their goal and it is not been attained by searching outside. The following stanzas from “Kagapusundar Gnanam 80” texts written by Siddhar Kagapusundar clearly states that “the divine power is inside you, without knowing it why this mankind is wasting their time in searching for several forms of divine power. The Siddha System contains unlike blend of remedy for similar ailment. Medicine will be handled by the Siddha physician based on Ayim bootham, Aaru aatharam, suvai, pragiruthi, Paalinam, three humors like Vali, Azhal, Iyam etc. This indicates individualism of siddha medicine purely depends on Siddha physiology to validate the root cause of disease by Envagai thervugal, especially Naadi-pulse reading method. It is good for a physician to diagnose the disease, trace its cause, how it may be moderated and then to use his expert skill. Siddha system of medicine provides the healthiness and care through Prophylaxis (Noyillaneri), Treatment (Maruthuvam) and Rejuvenation (Kayakarpam). For a physician, it nourishes knowledge about the art of diagnosis (Noi Nadal), pharmacology (Gunapadam) and toxicology (Nanjumurivu nool). Siddhars are excellent in the documentation work and they taught the above said sciences to their disciples too. They wrote their works in manuscripts which is the spinal column for generations of Traditional healers and Siddha physicians. PRECLINICAL SAFETY EVALUATION OF AAGASAGARUDAN KIZHANGU CHOORANAM 1 INTRODUCTION In Siddha system of medicine, Chooranam based on pure herbals is one of the first line of medicine for the several diseases. The shelf-life of chooranam is three months1 Siddha system of medicine is self sufficient to meet the needs of public health. It is high time to work on the feature assertion, safety and efficiency of Siddha formulations to make our system advantageous for inhabitants at large. The branch of Toxicology is developed by our forefathers to save the mankind. They discussed about the toxic effect of drugs and noxious bites with treatment to prevent the mortality circumstances. Siddhar’s and traditional healers have well knowledge about the safety aspects in therapeutic practice. The Aagasagarudan kizhangu is commonly called as “Kollankovai kizhangu”, “Garudan”, “Aagayagarudan”, “Peicheenthil”, etc. According to Thiru.T.V.Sambasivam pillai dictionary, the word „Aagasagarudan‟ refers to ‘root living in air’. It is a climbing shrub with yellow flowers2. The therapeutic uses of Aagasagarudan kizhangu are indicated for Virulent poison (Kodiya nanju), Anemia (Paandu), Pruritus (Namaichal), Thyroidism (Kazhuththu Kazhalai), Leprosy (Perunoi), Herpes zooster (Akkipun)3. I wished for working in the field of Siddha toxicology and was permitted to do the safety evaluation of ‘Aagasagarudan kizhangu Chooranam’- a Siddha herbal preparation which is indicated for several illness and virulent noxious bite. Snake bite is a life threatening problem causing mortality from ancient period to till date. About 94,000 snake bite deaths are recorded globally and 15000 in India per year4. Even today treating the noxious cases is a dare to the medical profession, but treating such noxious cases through the Siddha system of medicine seems to be more abundant and cost effective, hence this meticulous formulation had
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