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With Siddha Herbal – Mineral Formulation Drug “Samuthara Chooranam”(Internal), “Vadha Noiku Veliprayogha Thailam”(External) & Ottradam

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With Siddha Herbal – Mineral Formulation Drug “Samuthara Chooranam”(Internal), “Vadha Noiku Veliprayogha Thailam”(External) & Ottradam AN OPEN COMPARATIVE CLINICAL EVALUATION ON “UTHIRAVADHA SURONITHAM (RHEUMATOID ARTHRITIS)” WITH SIDDHA HERBAL – MINERAL FORMULATION DRUG “SAMUTHARA CHOORANAM”(INTERNAL), “VADHA NOIKU VELIPRAYOGHA THAILAM”(EXTERNAL) & OTTRADAM The dissertation Submitted by Dr. A. B. KAVINAYA Registration No. 321513101 Under the Guidance of Prof. Dr. M. MOHAMED MUSTHAFA, M.D(S) Dissertation submitted to THE TAMILNADU Dr. MGR MEDICAL UNIVERSITY CHENNAI-600032 For the partial fulfillment of the Requirement to the Degree of DOCTOR OF MEDICINE (SIDDHA) BRANCH-III-SIRAPPU MARUTHUVAM POST GRADUATE DEPARTMENT OF SIRAPPU MARUTHUVAM THE GOVERNMENT SIDDHA MEDICAL COLLEGE CHENNAI -106 OCTOBER 2018 GOVT. SIDDHA MEDICAL COLLEGE, CHENNAI - 106 DECLARATION BY THE CANDIDATE I hereby declare that this dissertation entitled An open comparative clinical evaluation on “Uthiravadha suronitham (Rheumatoid arthritis)” with siddha herbal – mineral formulation drug “Samuthara Chooranam” (Int), “Vadha Noiku Veliprayogha Thailam” (Ext) & Ottradam is a bonafide and genuine research work carried out by me under the guidance of Prof. Dr. M. MOHAMED MUSTHAFA, M.D(S), Post Graduate Department of Sirappu Maruthuvam, Govt. Siddha Medical College, Arumbakkam, Chennai- 600106 and the dissertation has not formed the basis for the award of any Degree, Diploma, Fellowship or other similar title. Date: Signature of the Candidate Place: Chennai Dr. A. B. KAVINAYA GOVT. SIDDHA MEDICAL COLLEGE, CHENNAI - 106 CERTIFICATE BY THE GUIDE This is to certify that the dissertation entitled An open comparative clinical evaluation on “Uthiravadha suronitham (Rheumatoid arthritis)” with siddha herbal – mineral formulation drug “Samuthara Chooranam” (Int), “Vadha Noiku Veliprayogha Thailam” (Ext) & Ottradam is submitted to the Tamilnadu Dr. M.G.R. Medical University in partial fulfillment of the requirements for the award of degree of M.D (Siddha) is the bonafide and genuine research work done by A. B. KAVINAYA under my supervision and guidance. The dissertation has not formed the basis for the award of any Degree, Diploma, and Associate ship, Fellowship or other similar title. Date: Seal & Signature of the Guide Place: Chennai Prof. Dr. M. MOHAMED MUSTHAFA, M. D(S), GOVT. SIDDHA MEDICAL COLLEGE, CHENNAI – 106 ENDORSEMENT BY THE HOD, PRINCIPAL/HEAD OF THE INSTITUTION This is to certify that the dissertation entitled An open comparative clinical evaluation on “Uthiravadha suronitham (Rheumatoid arthritis)” with siddha herbal – mineral formulation drug “Samuthara Chooranam”(Int), “Vadha Noiku Veliprayogha Thailam”(Ext) & Ottradam is a bonafide work carried out by A. B. KAVINAYA during the year 2015-2018 under the guidance of Prof. Dr. M. MOHAMED MUSTHAFA, M.D (S), Post Graduate Department of Sirappu Maruthuvam, Govt. Siddha Medical College, Chennai - 600 106. Seal & Signature of the HOD Seal & Signature of the Principal Date: Date: Place: Chennai Place: Chennai ACKNOWLEDGEMENT/2018 ACKNOWLEDGEMENT First and above all I praise god, the almighty for providing me this opportunity and granting me the capability to proceed successfully. This clinical study appears in its current form due to the assistance and guidance of several people. I would therefore like to offer my sincere thanks to all of them. I would like to express my cordial thank to my guide (my esteemed promotor) Prof. Dr. M. Mohamed Musthafa M.D(S) for accepting as his student. I feel proud to be his student and it was a rich experience to carry out the clinical study under his sagacious guidance. I am really grateful for his patience, motivation, warm encouragement, thoughtful guidance, critical comments, immense knowledge in literature and correction of the thesis. It gives me immense pleasure to thank the Vice Chancellor of The Tamilnadu Dr. M.G.R Medical University, Guindy, Chennai and to the Commissioner of Indian Medicine and Homoeopathy Department, Arumbakkam, Chennai-106 for giving me permission to do the dissertation. I also wish to express my appreciation and gratitude to Prof. Dr. K. Kanagavalli M.D(S), the Principal, GSMC, Chennai for providing all the facilities in the college and creating a vibrant environment for my study. It is with immense gratitude that I acknowledge the support of Dr. G. Sekar M.D(S), HOD of Puramarthuvam and Dr. Saibudeen M.D(S), HOD of Yoga maruthuvam, GSMC, Chennai for doing my clinical study. I owe my deepest gratitude to Dr. T. R. Siddique Ali M.D(S), PG Department of Varma maruthuvam for his support and valuable suggestions to improve my clinical study. I would like to gratefully acknowledge Dr.Saravanadevi M.D(S), HOD of Gunapadam, GSMC, Chennai for their guidance and support in authentication of minerals. ACKNOWLEDGEMENT/2018 I am also indebted to Dr. S. Sankaranarayanan, HOD of Maruthuva Thavaraviyal (Medicinal botany & Pharmacognosy), GSMC, Chennai for their guidance and support in authentication of herbal plants. I express my deep sense of gratitude to the Chairman and members of Institutional Ethics Committee(IEC), GSMC, Chennai for giving their approval to my clinical study. I wish to express my sincere thanks to Dr. P. Muralidharan, the pharmacologist and the members of Institutional Animal Ethics Committee(IAEC), C. L. Baid Metha College of Pharmacy, Thoraipakkam, Chennai-97 for giving their approval and their guidance in my toxicological study. I also express my heartfelt thanks to Prof. Rajesh, Biogenix Research Institute, Trivandrum for their assistance in my pharmacological study. It is an honor for me to thank Noble Research Solutions, Chennai for their guidance and support in doing Organaoleptic characters, Physico-chemical analysis, Heavy metal analysis, TLC & HPTLC analysis and Sterility method in my clinical trial medicine. I wish to express my appreciation to Dr. Manivasagam, B.S.M.S, M.Sc Epidemiology for helping me to do Biostatical analysis. I am also truly indebted to Dr. Kannan, HOD of Literary Research and Documentation Department, SCRI, Chennai and Mr. V. Dhandayuthapani, Librarian, Dr. Ambedkar library, GSMC, Chennai for their help in the collection of literature reviews. I express my hearted appreciation to Laboratary staff of Govt. Siddha Medical College and Arignar Anna Govt Hospital for Indian Medicine & Homoeopathy, Arumbakkam, Chennai for providing the valuable lab results. ACKNOWLEDGEMENT/2018 It’s my bounded duty to thank my Patients for their kind co-operation and patience which helps to complete my clinical study successfully. I heartedly thank my seniors Dr. Aruna M.D(S), Dr. Sreedhana M.D(S), Dr. Rajanandhini M.D(S), Dr. Anitha M.D(S), Dr. Kalaimani M.D(S) for their moral support and words of encouragement to complete this clinical research. My sincere thanks to all my colleagues and juniors who helped me directly or indirectly in the completion of my dissertation work. I am always grateful to my parents and my brother who are responsible for my growth. They really paved the way to success. I express my special thanks to my husband Dr. S. Tamilkanal B.D.S, who helped me to concentrate on completing this clinical study and gave me the moral support during the course of this work. I am forever indebted to him. I am also grateful to my family relatives for their earnest support to finish the clinical study completely. Thankyou all CONTENTS S.NO TITLE PAGE NO 1. INTRODUCTION 1 2. AIM AND OBJECTIVES 4 3. REVIEW OF LITERATURES 3.1 SIDDHA ASPECT OF THE DISEASE - UTHIRAVADHA 5 SURONITHAM 3.2 MODERN ASPECT OF THE DISEASE – RHEUMATOID 37 ARTHRITIS 3.3 DRUG REVIEW 1. INTERNAL DRUG REVIEW – SAMUTHARA 77 CHOORANAM 2. EXTERNAL DRUG REVIEW – VADHA NOIKU 92 VELIPRAYOGHA THAILAM 4. MATERIALS AND METHODS 4.1 METHOD OF PURIFICATION & PREPARATION OF 101 INTERNAL MEDICINE – SAMUTHARA CHOORANAM 4.2 METHOD OF PURIFICATION & PREPARATION OF 106 EXTERNAL MEDICINE – VADHA NOIKU VELIPRAYOGHA THAILAM 4.3 PROCEDURE FOR OTTRADAM (THERAPY) 111 4.4 STANDARDIZATION PARAMETERS 1. ORGANOLEPTIC CHARACTERS 112 2. PHYSICO-CHEMICAL EVALUATION 112 3. HEAVY METAL ANALYSIS BY AAS 114 4. TLC AND HPTLC ANALYSIS 114 5. PHYTOCHEMICAL ANALYSIS 115 6. STERILITY TEST BY POUR PLATE METHOD 117 4.5 TOXICOLOGICAL STUDY 1. ACUTE ORAL TOXICITY STUDY 118 2. REPEATED DOSE 28-DAY ORAL TOXICITY 122 STUDY 4.6 PHARMACOLOGICAL STUDY IMMUNOMODULATOR ACTIVITY 126 4.7 CLINICAL STUDY 127 5. RESULTS AND OBSERVATIONS 132 6. DISSCUSSION 189 7. SUMMARY 194 8. CONCLUSION 196 9. BIBLIOGRAPHY 198 10. ANNEXURES introduction INTRODUCTION/2018 1. INTRODUCTION Siddha system of medicine is one of the long-lived traditional system which is gradually evolved along with Dravidian’s culture and hence this system is known as Dravidian system of medicine. This system was contemporaneous with those of the submerged lands, Egyptian, Mesopotamian, Chinese and Greciam medicine. The unique nature of this medicine is the continuous service to humanity for more than 5000 years in combating diseases and in maintaining physical, mental, moral and spiritual components of human beings and to make the body perfect, imperishable, hence to promote longevity. This is the ancient synthetic chemico – philosophical system, which deals with 1.Vada(Alchemy) 2.Vaidhya(Medicine) 3.Gnanam(Wisdom) and 4.Yoga 1. Alchemy – chemistry which deals and treats of transforming in clear lucid fashion in all its branches of changing baser metals to higher by minerals, vegetables and animals. 2. Vaidhya – is that of medicine by chemistry for the ailments of man. 3. Gnana – is the study of nature, matter, soul and of man and human society and the scientific modulation of man and universal god. 4. Yoga – is the practice of Brahma vidya or Raja yoga to attain the “Moksham” Siddha system has unique art of healing founded by great spiritual scientist called “SIDDHARS”. The term SIDDHAR has derived from the word ‘SIDDHI’ which literally means accomplished, achieved or success and so it refers to one who had attained his end in spiritual goal by focusing Eight Supernatural Power “Ashtamaha Siddhi”. They belong to the class of EIGHTEEN SUPERNALS or DEMIGODS inhabiting the middle air and embracing several subdivisions, hence the following proverb is applicable only to them.
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