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Diabetic Neuropathy) A PROSPECTIVE OPEN LABELLED NON RANDOMIZED PHASE-II CLINICAL TRIAL OF “KADUKKAI CHOORANAM FOR “AKKINI SELATHUMAM” (DIABETIC NEUROPATHY) Dissertation submitted to THE TAMILNADU DR. MGR. MEDICAL UNIVERSITY CHENNAI-32 For the partial fulfillment of the requirements to the Degree of DOCTOR OF MEDICINE (SIDDHA) BRANCH-I DEPARTMENT OF POTHU MARUTHUVAM DEPARTMENT OF POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI - 627 002 TAMIL NADU, INDIA. OCTOBER 2019 GOVERNMENT SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI - 627 002 TAMIL NADU, INDIA. BONAFIDE CERTIFICATE This is to certify that the dissertation entitled “A PROSPECTIVE OPEN LABELLED NON RANDOMIZED PHASE-II CLINICAL TRIAL OF “KADUKKAI CHOORANAM FOR AKKINI SELATHUMAM (DIABETIC NEUROPATHY)” is abonafide work done by Dr.RAJENDRAM AJANTHAN (Reg. No.321611008) Govt. Siddha Medical College, Palayamkottai - 627 002 in partial fulfilment of the university rules and regulations for award for MD (S) POTHU MARUTHUVAM (BRANCH-I) under my guidance and supervision during the academic year OCTOBER 2016-2019. Supervisor and Guide Prof. Dr.A.MANOHARAN, MD (S),( Ph.D). Head, Department of PothuMaruthuvam, Govt. Siddha Medical College, Palayamkottai. Name and signature of the HOD Name and signature of the Principal Prof. Dr. A.MANOHARAN, MD (S),( Ph.D). Prof. Dr.S.Victoria,MD(S) Dept. of PothuMaruthuvam, Govt. Siddha Medical College Govt. Siddha Medical College, Palayamkottai. Palayamkottai. GOVERNMENT SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI - 627 002 TAMIL NADU, INDIA. CERTIFICATE Certified that I have gone through the dissertation entitled “A PROSPECTIVE OPEN LABELLED NON RANDOMIZED PHASE-II CLINICAL TRIAL OF “KADUKKAI CHOORANAM FOR AKKINI SELATHUMAM (DIABETIC NEUROPATHY)” submitted by Dr.RAJENDRAM AJANTHAN (Reg. No.321611008) a student of final year MD(S) Department of Pothu Maruthuvam (Branch-I)of this college and the dissertation work has been carried out by the individual only. This dissertation does not represent or reproduce.The dissertation submitted and approved earlier. Head of the Department, P.G Pothu Maruthuvam (Branch-I), Govt. Siddha Medical College, Palayamkottai. GOVERNMENT SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI - 627 002 TAMIL NADU, INDIA. PLAGIARISM CERTIFICATE This is to certify that this dissertation work titled “A PROSPECTIVE OPEN LABELLED NON RANDOMIZED PHASE-II CLINICAL TRIAL OF “KADUKKAI CHOORANAM FOR AKKINI SELATHUMAM (DIABETIC NEUROPATHY)’’ of the candidate Dr.RAJENDRAM AJANTHAN (Reg. No.321611008) for the award of M.D (Siddha) in the branch of Pothu Maruthuvam. I personally verified the urkund.com website for the purpose of plagiarism check. I found that the uploaded thesis file contains from introduction to conclusion pages and result shows 15 percentage of plagiarism in the dissertation. Supervisor and Guide Prof. Dr.A.MANOHARAN, MD (S),( Ph.D). Head, Department of PothuMaruthuvam, Govt. Siddha Medical College, Palayamkottai GOVERNMENT SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI - 627 002 TAMIL NADU, INDIA. DECLARATION BY THE CANDIDATE I, Dr.R.Ajanthan declare that the dissertation entitled “A PROSPECTIVE OPEN LABELLED NON RANDOMIZED PHASE-II CLINICAL TRIAL OF “KADUKKAI CHOORANAM FOR AKKINI SELATHUMAM (DIABETIC NEUROPATHY)’’submitted for the degree of MD Siddha Medicine of Government Siddha Medical College, Palayamkottai, Tirunelveli, Tamil Nadu(The Tamil Nadu Dr. M.G.R. Medical University, Chennai) the record of work carried out by me under the supervision and guidance of Prof. Dr.A.Manoharan, MD(S),(Ph.D). Head, Department of Pothu Maruthuvam, Govt. Siddha Medical College, Palayamkottai. This work has not formed the basis of award of any degree, diploma, associateship, fellowship or other titles in the university or any other university or institution of higher learning. Signature of the candidate (Dr. RAJENDRAM AJANTHAN) Place : Palayamkottai Date : ACKNOWLEGEMENT My greatest gratitude goes to God for seeing me through the programme. I express my profound thanks to the Honourable Vice-Chancellor, Tamil Nadu Dr. M.G.R. Medical University, Chennai for permitting me to do this dissertation work. My sincere thanks to Prof. Dr.S.Victoria,MD(S) Principal Government Siddha Medical College, Palayamkottai for permitting me to avail the facilities in this institution. I also wish to express my sincere gratitude to my supervisor, Prof. Dr.A.Manoharan, MD(S), (Ph.D). Head, Department of PothuMaruthuvam, Government Siddha Medical College, Palayamkottai, Tirunelveli for his encouragement, patience, guidance and his excellent supervision during my stay at the Department. My sincere thanks to Dr.Neelavethy,MD(S),Ph.D. former principal of Govt.Siddha Medical College and Hospitdl,Palayamkottai,who permitted and initiated this dissertation work. Also my deeply gratitude and thanks to Academic staff of Department of PothuMaruthuvamGSMC, Palayamkottai, Tirunelveli Dr.T.Komalavalli, MD(S),Ph.D. (Associate Professor), Dr.S.Justus Antony, MD(S), Dr.Thomas Walter, MD(S) Dr.G.Subash Chandran, MD(S),Ph.D. Dr.P.Sathishkumar MD(S), and Dr.S.Umakalyani, MD(S) for their help and support me during study. I extend my grate fulness to Dr.(Mrs).S.Sutha, M.Sc, Ph.D. Head, Department of Herbal Botany and Herbal Pharmacognosy, GSMC, Palayamkottai, Tirunelvelifor the help rendered in identification and authentication of herbs and drugs.I express my deep sense of gratitude to Mrs.N.Naga Prema, M.Sc, M.Phil. and other staff members of the Department of Biochemistry who helped me in biochemical analysis of the trial medicines. I would like to express my heart full thanks to Dr.M.Kalaivanan, M.Sc, M.Phil.,Ph.D. Lecturer, Department of Pharmacology, GSMC, Palayamkottai, Tirunelveli, for his technical Guidance and valuable suggestions.I sincerely thank Dr.N.Chidambaranathan, M.Pharm, Ph.D. Vice Principal, K.M.College of Pharmacy, and Madurai who investigated the pharmacological actions of the trial medicine. I whole heartedly thank Mrs.T.Poongodi, M.Lis, M.Phil., Librarian for her assistance in collection of literatures. My appreciation also goes to the entire laboratory staff, GSMCH, Palayamkottai for their help during the collection of samples. Last but not least my appreciation and thanks to everyone who helped me in different ways during the study period. CONTENTS CHAPTER PAGE TITLE No. No. ABBREVIATIONS ABSTRACT I. INTRODUCTION 1.1 Background 1 1.2 General Aim of Study 4 1.3 Justification of Research 5 II. REVIEW OF LITERATURE 2.1. In Journal – Kadukkai 6 2.1. 1 Siddha literature 11 2.1.2 Gunapadam aspect 12 2.2 Siddha Aspect – Akkini Selathumam 14 2.2.1 Pathogenesis 15 2.3 Siddha Aspect – Madhumegam 16 2.3.1 . Definition of Madhumegam 17 2.3.2 .Etiology 17 2.3.3.Classification 22 2.3.4.Primary Symptoms of Madhumegam 23 2.3.5 Signs and Symptoms of Madhumegam 24 2.3.6 Common Sign and Symptoms of Vatha, 25 Pitha and KaphaMegam 2.3.7.Pathogenesis. 30 2.3.8.Complications of Disease 31 2.3.9.Prognosis of the Disease 32 2.3.10.Diagnosis of the Disease 33 2.3.11 .Differential Diagnosis 39 2.3.12. Line of Treatment 40 CHAPTER PAGE TITLE No. No. 2.4 Modern Aspect - Diabetes Millutus 43 2.4.1 Definition and description of diabetes mellitus 43 2.4.2 Epidemiology 44 2.4.3 Classification of diabetes mellitus 44 2.4.3.1 Type-I diabetes mellitus 46 2.4.3.2 Type-II diabetes mellitus 46 2.4.4 Complications of diabetes mellitus 47 2.4.4.1 Acute Complications 47 2.4.4.2 Chronic Complications 48 2.4.4.3 Macrovascular Complications 48 2.4.4.4. Neuropathy 49 2.4.5 Diabetic dyslipidemia 53 2.4.6 Glycated Haemoglobin (HbA1C) 53 III. MATERIALS AND METHODS 3.1 Study Area and Setting 54 3.2 Study Design 54 3.3 Selection of Patients 54 3.3.1 Inclusion Criteria 55 3.3.2 Exclusion Criteria 55 3.3.3 Diagnosis 55 3.3.4 Investigations 55 3.4 Treatment 56 3.4.1 Preparation of Trial Medicine 56 Annexure-I 3.4.2 Collection and authentication of Trial 56 Medicine - Annexure-II 3.4.3 Ethical Review 57 3.4.4 Study Enrolment 57 3.4.5 Statistical Analysis 58 CHAPTER PAGE TITLE No. No. IV. RESULTS AND OBSERVATIONS 59 4.1.Pre clinical study 59 4.2. Clinical study 74 V. DISCUSSION 120 VI. SUMMARY 129 VII. CONCLUSION 131 VIII. BIBILOGRAPHY 133 IX. ANNEXURES ANNEXURE-I i ANNEXURE-11 ii ANNEXURE-III(A) iv ANNEXURE-III(B) vi ANNEXURE-IV x ANNEXURE-V xiii ANNEXURE-VI xiv ANNEXURE-VII xxiii LIST OF TABLES TABLE PAGE TITLE No. No. 1 Distribution of Gender 76 2 Distribution of Age 77 3 Distribution of Educational Status 78 4 Distribution of Occupation 79 5 Distribution of Religion 80 6 Distribution of Marital Status 81 7 Distribution of Clinical Manifestation 82 8 Distribution of Duration of Illness 83 9 Distribution of Family History 84 10 Distribution of Previous Treatment 85 11 Distribution of Personal History 86 12 Distribution of Socio-Economical Status 87 13 Distribution of Other System Involvement 88 14 Body Mass Index 89 15 Distribution of Constitution of Body 90 16 Distribution of Gunam 91 17 Distribution of Kaalam 92 18 Distribution of ParuvaKaalam 93 19 Distribution of Thinai 94 20 (a) Derangement of Vatham 95 20 (b) Derangement of Pitham 96 20 (c) Derangement of Kapham 97 21 Involvement of UdalThathukkal 98 22 Distribution of Kanmenthiriyam 99 23 Distribution of Imporigal (Gnanenthirium) 100 24 Distribution of Kosam 101 25 Distribution ofNeerKuri 103 TABLE PAGE TITLE No. No. 26 Distribution of NeiKuri 104 27 (a) HbA1C 105 27 (b) Lipid Profile 106 28 Changes in diagnostic findings before and after 107 treatment 29 a) Changes in Nerve conduction study and Neuropathic 109 pain score 29 b) Changes in HbA1C, Blood Sugar and Lipid Levels 114 before
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