EVIDENCE-BASED RESEARCH IN AYURVEDA AGAINST COVID-19 IN COMPLIANCE WITH STANDARDIZED PROTOCOLS AND PRACTICES

Cover\nTitle\nCopyright\nEnd User License Agreement\nEndorsment\nContents\nForeword\nPreface\n	CONSENT FOR PUBLICATION\n	CONFLICT OF INTEREST\n	ACKNOWLEDGEMENT\nVirtual Screening and Computational Study\n	1.1. SARS-COV-2 OUTBREAK AND HELPLESSNESS OF MANKIND\n	1.2. MOLECULAR ETIOLOGY OF COVID-19\n	1.3. FINDING THE CURE: HOPE VERSUS REALITY\n	1.4. THE WAY FORWARD: AYURVEDA AGAINST COVID-19\n		1.4.1. Scientific Rationale Behind Pure Extract of Ashwagandha (W. somnifera) as Anti- SARS-CoV-2 Agent\n			1.4.1.1. Pharmacological Perspective of Using Ashwagandha\n			1.4.1.2. Computational Evidence for W. somnifera as Anti-SARS-CoV-2 Agent\n		1.4.2. Scientific Rationale behind Pure Extract of Giloy (T. cordifolia) as Anti-SARS- CoV-2 Agent\n			1.4.2.1. Pharmacological Perspective of Using Giloy\n			1.4.2.2. Computational Evidence for T. cordifolia as Anti-SARS-CoV-2 Agent\n		1.4.3. Scientific Rationale Behind Pure Extract of Tulsi (O. sanctum) as Anti-SARS-CoV-2 Agent\n			1.4.3.1. Pharmacological Perspective of Tulsi and its Phytocomponents\n			1.4.3.2. Computational Evidence for O. sanctum as Anti-SARS-CoV-2 Agent\n	CONCLUDING REMARKS\nFormulation, Licensing, Chemical Characterization, and Validation of Ayurvedic Medicine\n	SELECTION OF RAW MATERIAL\n	SAMPLING OF RAW MATERIAL\n	RECOMMENDED PROCEDURES OF SAMPLING\n		Sampling of Material in Bulk\n		Sampling of Material in Retail Packages\n		i). The N Plan\n		ii). The P Plan\n		iii). The R Plan\n		Types of Sampling Tools\n		i. Scoops\n		ii. Dip Tubes\n		iii. Weighted Containers\n		iv. Thieves\n		v. Simple Bag-Sampling Spears\n	QUALITY CONTROL OF RAW MATERIALS AND FINISHED PRODUCTS\n		Physical Parameters\n		Chemical Parameters\n		Contamination\n			Microbiological Contamination\n			Heavy Metals\n		Residual Solvent\n	RESIDUAL PESTICIDES\n		Aflatoxins\n		Other Contamination\n	RAW MATERIALS USED FOR MAKING CORONIL\n		Chemical Characterization of Tulsi\n		UPLC/QToF MS Study of Tulsi\n		HPLC-PDA Method Development for standardization of Tulsi\n			HPLC-PDA Method Validation for Standardization of Tulsi\n			HPTLC Method Development for Standardization of Tulsi Experiment Methods\n			HPTLC Method Validation for Standardization of Tulsi Linearity for Rosmarinic Acid\n			Chemical Characterization of Ashwagandha\n		UPLC/QToF MS study of Ashwagandha\n		HPLC-PDA Method Development for Standardization of Ashwagandha Extract\n		Standard Stock Solution\n		HPLC-PDA Method Validation for Standardization of Ashwagandha Extracts\n		HPTLC Method Development for Standardization of Ashwagandha\n		Chromatographic Conditions\n		HPTLC Method Validation for Standardization of Ashwagandha Extract\n			Conclusion:\n			Chemical Characterization of Giloy\n		HPLC-PDA Method Development for Standardization of Giloy:\n		HPTLC Method Development for Standardization of Giloy Experiment Methods\n		Quantification of Magnoflorine\n			Results\n			Chemical Characterization of Coronil Tablet\n			HPLC Condition\n			Standard Preparation\n		HPTLC Method Development for Standardization of Coronil Tablet\n			HPTLC Method Validation for Standardization of Ashwagandha\n			Chemical Characterization of Divya Swasari Vati\n		HPLC-PDA Method Validation for Standardization of Divya Swasari Vati\n			HPTLC Method Development for Standardization of Divya Swasari Vati Experiment Methods\n			Chromatographic Conditions\n			HPTLC Method Validation for Standardization of Divya Swasari Vati A.1:\n	CONCLUDING REMARKS\nUnderstanding the Mode of Action of the Medicine through In-Vitro Studies\n	3.1. EXPERIMENTAL VALIDATION OF COMPUTATIONAL OBSERVATION\n	3.2. CORONIL AS A POTENTIAL ANTIVIRAL AGENT AGAINST SARS-COV-2\n		3.2.1. Insight into the Entry Inhibitory Mechanism of Coronil\n		3.2.2. Coronil is an Entry Inhibitor of SARS-CoV-2 into the Host Cell\n		3.2.3. Coronil as an Anti-inflammatory Agent\n	3.3. POTENTIALS OF SWASARI AGAINST SARS-COV-2\n		3.3.1. Scientific Rationale of Using Swasari against SARS-CoV-2\n		3.3.2. Swasari against SARS-CoV-2 Specific Inflammation\n	CONCLUDING REMARKS\nUse of In Vivo Models in Preclinical Drug Discovery and Development\n	4.1. RATIONALE FOR THE USE OF IN VIVO MODELS\n	4.2. WHY ZEBRAFISH?\n	4.3. ESTABLISHMENT OF XENOTRANSPLANTED HUMANIZED ZEBRAFISH MODEL\n	4.4. INDUCTION OF DISEASE PHENOTYPE IN HUMANIZED ZEBRAFISH MODEL USING SARS-COV- 2 SPIKE PROTEIN\n	4.5. IN VIVO MODEL FOR DEMONSTRATION OF EFFECTIVENESS OF CORONIL IN REDUCING SARS-COV-2 SPIKE PROTEIN-INDUCED DISEASE PHENOTYPE\n		4.5.1. Coronil Attenuates SARS-CoV-2 Spike Protein-Induced Inflammation in Swim Bladder\n		4.5.2. Coronil Inhibits SARS-CoV-2 Spike Protein-Induced Renal Cell Necrosis\n		4.5.3. Coronil Attenuates SARS-CoV-2 Spike Protein-Induced Hemorrhage\n		4.5.4. Coronil Dampens the Gene Expression Levels of Pro-inflammatory Cytokines\n		4.5.5. Coronil Reduces SARS-CoV-2 Spike Protein-induced Behavioural Fever\n	4.6. IN VIVO MODEL FOR DETERMINING THE EFFECTIVENESS OF DIVYA SWASARI VATI IN REDUCING SARS-COV-2 SPIKE PROTEIN-INDUCED DISEASE PHENOTYPE\n		4.6.1. SARS-CoV-2 Spike Protein-Induced Edema in the Swim Bladder which is Reversed by Administration of Divya Swasari Vati\n		4.6.2. Restoration of Cytological Profile and Reversal of Pro-inflammatory Cell Infiltration in Swim Bladder after Treatment with Divya Swasari Vati\n		4.6.3. Divya Swasari Vati Treatment Reversed the SARS-CoV-2 Spike Protein-Induced Cytokine Gene Expression In vivo\n		4.6.4. SARS-CoV-2 Spike Protein-Induced Tubular Degeneration and Necrosis of the Kidney was Rescued Divya Swasari Vati Treatment\n		4.6.5. Cytological Examination of the Kidney for Necrosis Induced by SARS-CoV-2 Spike Protein\n		4.6.6. Divya Swasari Vati Reversed the Skin Hemorrhage caused by the Induction with the Recombinant Spike Protein of SARS-CoV-2\n		4.6.7. Divya Swasari Vati Rescued Changes to the Behavioral Fever Phenotype Post Induction with Spike Protein of SARS-CoV-2\n		4.6.8. Vati Enhanced Survival of Zebrafish after Induction of Disease Symptoms with the Recombinant Spike Protein of SARS-CoV-2\n	CONCLUDING REMARKS\nImportance of Studying Adverse Effects of High Doses of Drugs Using Toxicology Studies\n	5.1. BACKGROUND\n	5.2. RATIONALE BEHIND THE USE OF TOXICOLOGY STUDIES\n	5.3. INSTITUTIONAL REQUIREMENTS\n		5.3.1. Principles of Good Laboratory Practice (GLP) and Compliance Monitoring As\n			Mandated by OECD\n		5.3.2. Terms and Conditions of ‘National GLP Compliance Monitoring Authority’ (NGCMA), for Obtaining and Maintaining GLP Certification by a Test Facility\n		5.3.3. CPCSEA Guidelines for Laboratory Animal Facility\n	5.4. STUDY REQUIREMENTS\n	5.5. DESCRIPTION OF HUSBANDRY CONDITIONS AND ANIMAL REQUIREMENTS\n		5.5.1. Animals\n		5.5.1.1. Rabbits\n		5.5.1.2. Rats\n		5.5.2. Housing Conditions\n		5.5.3. Preparation of the Dose Formulation\n		5.5.4. Observations\n			(i). Mortality and Clinical Signs Observations\n			(ii). Detailed Clinical Observations\n			(iii). Functional Observation Battery\n			(iv). Body Weight\n			(v). Feed Consumption\n			(vi). Ophthalmoscopic Examination\n			(vii). Clinical Pathology Observations\n	CONCLUDING REMARKS\nDesigning Clinical Research: Application on Evidence-based Practice\n	6.1. BACKGROUND TO CLINICAL RESEARCH\n		6.1.1. Patanjali Research Institute Quest to the Map-Design\n	6.2. CLINICAL STUDY DESIGN: THE ESSENTIALS\n		6.2.1. OBSERVATIONAL STUDY DESIGN\n		6.2.2. EXPERIMENTAL STUDY DESIGN\n	6.3. PRINCIPLES FOR CONDUCTING THE RESEARCH\n		6.3.1. Ethics and Good Clinical Practice\n		6.3.2. Important principles for conducting medical research in brief:\n	6.4. STUDY CENTERS: THE BACKBONE OF DRUG DEVELOPMENT\n	6.5. REGULATORY REQUIREMENTS AND AGREEMENTS\n		6.5.1. IRB/IEC Ethics Committees\n		6.5.2. Clinical Trial Agreements and Contracts\n	6.6. PRE-REQUISITES FOR RESEARCH PROTOCOL\n		6.6.1. Protocol: General Information and Protocol Synopsis\n		6.6.2. Background/Rationale\n		6.6.3. Clinical Trial Outcome/Endpoint\n		6.6.4. Clinical Trial Study Design\n		6.6.5. Randomization\n			6.6.5.1. Methods of Randomization\n		6.6.6. Blinding\n		6.6.7. Participants Inclusion and Exclusion Criteria:\n			6.6.7.1. Example:\n			6.6.7.2. Example:\n		6.6.8. Collection of Adverse Events/SAE\n		6.6.9. Recording of Adverse Events/SAE\n		6.6.10. Investigational Product Management\n		6.6.11. Data Analysis\n		6.6.12. Risk and Benefit Balance\n		6.6.13. Policy of Publication\n	6.7. ESSENTIAL TRIAL DOCUMENTS\n		6.7.1. Documentation of Informed Consent Process\n		6.7.2. Investigator Brochure\n	6.8. OVERVIEW OF RCT CONDUCTED AT NIMS HOSPITAL, JAIPUR, RAJASTHAN\n		6.8.1. Objective\n		6.8.2. Study Design\n		6.8.3. Interventions\n		6.8.4. Results\n		6.8.5. Conclusion\n	6.9. EVIDENCE-BASED STUDY OF PATANJALI AGAINST COVID-19\n		6.9.1. Study Population and Design of the Study\n		6.9.2. Inclusion and Exclusion criteria\n			6.9.2.1. Study Completion Criteria\n			6.9.2.2. Treatment\n		6.9.3. Patient Evaluation\n		6.9.4. Data Representation\n		6.9.5. Results\n			6.9.5.1. Freedom to Choose Treatment Options Affected the Sample Sizes of Study Groups\n			6.9.5.2. Age and Gender Distribution Among the Observed Patients\n			6.9.5.3. Patients on Natural Medicines Alone Exhibited Faster Recovery\n	CONCLUDING REMARKS\nPublic Health Research and Development\n	7.1. BACKGROUND OF PUBLIC HEALTH\n	7.2. PRINCIPLES OF PUBLIC HEALTH RESEARCH ETHICS\n	7.3. OUR CLINICAL STUDIES BASED ON PATIENT-REPORTED OUTCOMES\n		7.3.1. Role of Traditional Ayurvedic Regime in Relation to Treatment Satisfaction on Psychological Health and Quality of Life\n	7.4. RESULTS\n		7.4.1. Demographic Characteristics\n		7.4.2. Correlation Matrix between Treatment Satisfaction, Quality of Life, Psychological Health, and Demographic Characteristic\n	CONCLUDING REMARKS\nAppendices\nBibliography\nSubject Index\nBack Cover