This book details all the intricacies and essential knowledge involved in the research and development of the Coronil Kit – a combination of 3 ayurvedic medications for the common cold. It informs the reader about the huge potential of herbal drugs in fighting against any type of disease through evidence-based data of clinical trials and experiments. The book demonstrates how current scientific techniques can be applied to understand healing capacities of plants at their molecular level and thus utilizing their different natural product combinations to treat diseases by targeting harmful micro-organisms and simultaneously boosting the immune system. It covers methods of virtual screening and computational validation of identified phytochemicals as potential antiviral agents against the SARS-CoV-2 virus.
2. Covers guidance on drug formulation, hazard assessment and clinical trials based on approved methods by regulatory organizations
3. Covers pharmacological, toxicological and technically verified chemical composition of medicinal plants
4. Includes information about in vivo experiments and analysis of Humanoid Zebrafish trials
5. Includes methods of identifying antiviral agents against SARS-CoV-2 virus
6. Includes chemical, analytical and technical studies of Coronil
7. Includes 70 informative colored figures over 7 chapters
8. Includes a bibliography and appendix
The book is primarily intended as a primary resource for medical research scholars and researchers in pharmaceutical companies and as a secondary resource for B.A.M.S. students, medical postgraduate students and ayurveda enthusiasts.
Key features:
1. Covers the molecular etiology of COVID-19 virus,2. Covers guidance on drug formulation, hazard assessment and clinical trials based on approved methods by regulatory organizations
3. Covers pharmacological, toxicological and technically verified chemical composition of medicinal plants
4. Includes information about in vivo experiments and analysis of Humanoid Zebrafish trials
5. Includes methods of identifying antiviral agents against SARS-CoV-2 virus
6. Includes chemical, analytical and technical studies of Coronil
7. Includes 70 informative colored figures over 7 chapters
8. Includes a bibliography and appendix
The book is primarily intended as a primary resource for medical research scholars and researchers in pharmaceutical companies and as a secondary resource for B.A.M.S. students, medical postgraduate students and ayurveda enthusiasts.
Table of Contents
FOREWORD- i PREFACE
- ii CONSENT FOR PUBLICATION
- iii CONFLICT OF INTEREST
- iii ACKNOWLEDGEMENT
CHAPTER 1 VIRTUAL SCREENING AND COMPUTATIONAL STUDY
1. SARS-COV-2 OUTBREAK AND HELPLESSNESS OF MANKIND
2. MOLECULAR ETIOLOGY OF COVID-19
3. FINDING THE CURE: HOPE VERSUS REALITY
4. THE WAY FORWARD: AYURVEDA AGAINST COVID-19
4.1. Scientific Rationale Behind Pure Extract of Ashwagandha (W. somnifera) as AntiSARS-CoV-2 Agent
4.1.1. Pharmacological Perspective of Using Ashwagandha
4.1.2. Computational Evidence for W. somnifera as Anti-SARS-CoV-2 Agent
4.2. Scientific Rationale behind Pure Extract of Giloy (T. cordifolia) as Anti-SARS- CoV2 Agent
4.2.1. Pharmacological Perspective of Using Giloy
4.2.2. Computational Evidence for T. cordifolia as Anti-SARS-CoV-2 Agent
4.3. Scientific Rationale Behind Pure Extract of Tulsi (O. sanctum) as Anti-SARS-CoV-2 Agent
4.3.1. Pharmacological Perspective of Tulsi and its Phytocomponents
4.3.2. Computational Evidence for O. sanctum as Anti-SARS-CoV-2 Agent
- CONCLUDING REMARKS
CHAPTER 2 FORMULATION, LICENSING, CHEMICAL CHARACTERIZATION, AND VALIDATION OF AYURVEDIC MEDICINE
- SELECTION OF RAW MATERIAL
- SAMPLING OF RAW MATERIAL
- RECOMMENDED PROCEDURES OF SAMPLING
- Sampling of Material in Bulk
- Sampling of Material in Retail Packages
- i). The N Plan
- ii). The P Plan
- iii). The R Plan
- Types of Sampling Tools
- i. Scoops
- ii. Dip Tubes
- iii. Weighted Containers
- iv. Thieves
- v. Simple Bag-Sampling Spears
- QUALITY CONTROL OF RAW MATERIALS AND FINISHED PRODUCTS
- Physical Parameters
- Chemical Parameters
- Contamination
- Microbiological Contamination
- Heavy Metals
- Residual Solvent
- RESIDUAL PESTICIDES
- Aflatoxins
- Other Contamination
- RAW MATERIALS USED FOR MAKING CORONIL
- Chemical Characterization of Tulsi
- UPLC/QToF MS Study of Tulsi
- HPLC-PDA Method Development for standardization of Tulsi
- HPLC-PDA Method Validation for Standardization of Tulsi
- HPTLC Method Development for Standardization of Tulsi Experiment Methods
- HPTLC Method Validation for Standardization of Tulsi Linearity for Rosmarinic Acid 50 Chemical Characterization of Ashwagandha
- UPLC/QToF MS study of Ashwagandha
- HPLC-PDA Method Development for Standardization of Ashwagandha Extract
- Standard Stock Solution
- HPLC-PDA Method Validation for Standardization of Ashwagandha Extracts
- HPTLC Method Development for Standardization of Ashwagandha
- Chromatographic Conditions
- HPTLC Method Validation for Standardization of Ashwagandha Extract
- Conclusion:
- Chemical Characterization of Giloy
- HPLC-PDA Method Development for Standardization of Giloy:
- HPTLC Method Development for Standardization of Giloy Experiment Methods
- Quantification of Magnoflorine
- Results
- Chemical Characterization of Coronil Tablet
- HPLC Condition
- Standard Preparation
- HPTLC Method Development for Standardization of Coronil Tablet
- HPTLC Method Validation for Standardization of Ashwagandha
- Chemical Characterization of Divya Swasari Vati
- HPLC-PDA Method Validation for Standardization of Divya Swasari Vati
- HPTLC Method Development for Standardization of Divya Swasari Vati Experiment Methods
- Chromatographic Conditions
- HPTLC Method Validation for Standardization of Divya Swasari Vati A.1:
- CONCLUDING REMARKS
CHAPTER 3 UNDERSTANDING THE MODE OF ACTION OF THE MEDICINE THROUGH IN-VITRO STUDIES
1. EXPERIMENTAL VALIDATION OF COMPUTATIONAL OBSERVATION
2. CORONIL AS A POTENTIAL ANTIVIRAL AGENT AGAINST SARS-COV-2
2.1. Insight into the Entry Inhibitory Mechanism of Coronil
2.2. Coronil is an Entry Inhibitor of SARS-CoV-2 into the Host Cell
2.3. Coronil as an Anti-inflammatory Agent
3. POTENTIALS OF SWASARI AGAINST SARS-COV-2
3.1. Scientific Rationale of Using Swasari against SARS-CoV-2
3.2. Swasari against SARS-CoV-2 Specific Inflammation
- CONCLUDING REMARKS
CHAPTER 4 USE OF IN VIVO MODELS IN PRECLINICAL DRUG DISCOVERY AND DEVELOPMENT
1. RATIONALE FOR THE USE OF IN VIVO MODELS
2. WHY ZEBRAFISH?
3. ESTABLISHMENT OF XENOTRANSPLANTED HUMANIZED ZEBRAFISH MODEL
4. INDUCTION OF DISEASE PHENOTYPE IN HUMANIZED ZEBRAFISH MODEL USING SARS-COV- 2 SPIKE PROTEIN
5. IN VIVO MODEL FOR DEMONSTRATION OF EFFECTIVENESS OF CORONIL IN REDUCING SARS-COV-2 SPIKE PROTEIN-INDUCED DISEASE PHENOTYPE
5.1. Coronil Attenuates SARS-CoV-2 Spike Protein-Induced Inflammation in Swim Bladder
5.2. Coronil Inhibits SARS-CoV-2 Spike Protein-Induced Renal Cell Necrosis
5.3. Coronil Attenuates SARS-CoV-2 Spike Protein-Induced Hemorrhage
5.4. Coronil Dampens the Gene Expression Levels of Pro-inflammatory Cytokines
5.5. Coronil Reduces SARS-CoV-2 Spike Protein-induced Behavioural Fever
6. IN VIVO MODEL FOR DETERMINING THE EFFECTIVENESS OF DIVYA SWASARI VATI IN REDUCING SARS-COV-2 SPIKE PROTEIN-INDUCED DISEASE PHENOTYPE
6.1. SARS-CoV-2 Spike Protein-Induced Edema in the Swim Bladder which is Reversed by Administration of Divya Swasari Vati
6.2. Restoration of Cytological Profile and Reversal of Pro-inflammatory Cell Infiltration in Swim Bladder after Treatment with Divya Swasari Vati
6.3. Divya Swasari Vati Treatment Reversed the SARS-CoV-2 Spike Protein-Induced Cytokine Gene Expression In vivo
6.4. SARS-CoV-2 Spike Protein-Induced Tubular Degeneration and Necrosis of the Kidney was Rescued Divya Swasari Vati Treatment
6.5. Cytological Examination of the Kidney for Necrosis Induced by SARS-CoV-2 Spike Protein
6.6. Divya Swasari Vati Reversed the Skin Hemorrhage caused by the Induction with the Recombinant Spike Protein of SARS-CoV-2
6.7. Divya Swasari Vati Rescued Changes to the Behavioral Fever Phenotype Post Induction with Spike Protein of SARS-CoV-2
6.8. Vati Enhanced Survival of Zebrafish after Induction of Disease Symptoms with the Recombinant Spike Protein of SARS-CoV-2
- CONCLUDING REMARKS
CHAPTER 5 IMPORTANCE OF STUDYING ADVERSE EFFECTS OF HIGH DOSES OF DRUGS USING TOXICOLOGY STUDIES
1. BACKGROUND
2. RATIONALE BEHIND THE USE OF TOXICOLOGY STUDIES
3. INSTITUTIONAL REQUIREMENTS
3.1. Principles of Good Laboratory Practice (GLP) and Compliance Monitoring As
- Mandated by OECD
3.3. CPCSEA Guidelines for Laboratory Animal Facility
4. STUDY REQUIREMENTS
5. DESCRIPTION OF HUSBANDRY CONDITIONS AND ANIMAL REQUIREMENTS 202 5.5.1. Animals
5.1.1. Rabbits
5.1.2. Rats
5.2. Housing Conditions
5.3. Preparation of the Dose Formulation
5.4. Observations
(i). Mortality and Clinical Signs Observations
(ii). Detailed Clinical Observations
(iii). Functional Observation Battery
(iv). Body Weight
(v). Feed Consumption
(vi). Ophthalmoscopic Examination
(vii). Clinical Pathology Observations
- CONCLUDING REMARKS
CHAPTER 6 DESIGNING CLINICAL RESEARCH: APPLICATION ON EVIDENCE-BASED PRACTICE
1. BACKGROUND TO CLINICAL RESEARCH
1.1. Patanjali Research Institute Quest to the Map-Design
2. CLINICAL STUDY DESIGN: THE ESSENTIALS
2.1. OBSERVATIONAL STUDY DESIGN
2.2. EXPERIMENTAL STUDY DESIGN
3. PRINCIPLES FOR CONDUCTING THE RESEARCH
3.1. Ethics and Good Clinical Practice
3.2. Important principles for conducting medical research in brief:
4. STUDY CENTERS: THE BACKBONE OF DRUG DEVELOPMENT
5. REGULATORY REQUIREMENTS AND AGREEMENTS
5.1. IRB/IEC Ethics Committees
5.2. Clinical Trial Agreements and Contracts
6. PRE-REQUISITES FOR RESEARCH PROTOCOL
6.1. Protocol: General Information and Protocol Synopsis
6.2. Background/Rationale
6.3. Clinical Trial Outcome/Endpoint
6.4. Clinical Trial Study Design
6.5. Randomization
6.5.1. Methods of Randomization
6.6. Blinding
6.7. Participants Inclusion and Exclusion Criteria:
6.7.1. Example:
6.7.2. Example:
6.8. Collection of Adverse Events/SAE
6.9. Recording of Adverse Events/SAE
6.10. Investigational Product Management
6.11. Data Analysis
6.12. Risk and Benefit Balance
6.13. Policy of Publication
7. ESSENTIAL TRIAL DOCUMENTS
7.1. Documentation of Informed Consent Process
7.2. Investigator Brochure
8. OVERVIEW OF RCT CONDUCTED AT NIMS HOSPITAL, JAIPUR, RAJASTHAN 237 6.8.1. Objective
8.2. Study Design
8.3. Interventions
8.4. Results
8.5. Conclusion
9. EVIDENCE-BASED STUDY OF PATANJALI AGAINST COVID-19
9.1. Study Population and Design of the Study
Author
- Acharya Balkrishna
