Course

UNIT-I                                                                                                                         10 Hours

Complementary and Alternative Medicine Natural Products (CAM)

• An introduction to CAM (1hr).
• Define the following terms with suitable two examples of each with respect to CAM: Dietary supplements, Herbal or botanical products,Traditional medicine formulations, Folk medicines, Homeopathic remedies, Probiotics, Food-based phytochemicals (3hrs).
• Justify the efficacy and safety of CAM therapies based on any two available clinical studies (3hrs)
• Role in regulation of components of immune system (cells involved in immune response- T and B cells, macrophages, dendritic cells and natural killer cells) (2hrs)
• Limitations and future perspectives (1hr)

UNIT-II                                                                                                                       16 Hours

Nutraceuticals in Human Diseases

• General aspects and scope of nutraceuticals. Health benefits and role of Nutraceuticals in ailments like Diabetes, CVS diseases, Cancer and Gastrointestinal diseases. Market, growth, and types of products available in the market

(Examples:. Omega-3 fatty acids: Known for their heart health benefits and cognitive support.

Probiotics: Beneficial bacteria that support gut health and digestion.

Curcumin (from turmeric): A powerful antioxidant with anti-inflammatory properties.

Vitamin D: Essential for bone health and immune function.

Green tea extract: Rich in antioxidants and associated with various health benefits (8hrs)

• Study of the following herbs as health food: Fenugreek, Garlic, Amla, Ginger, Ashwagandha. Spirulina (3hrs)
• Herbal-Drug and Herb-Food Interactions: General introduction to interaction and classification. Study of the following drugs and their possible side effects and interactions: Hypericum, kava-kava, Ginkgo biloba, Ginseng, Garlic, Pepper & Ephedra. (4hrs)
• AI-enabled Herb-Drug Interaction Analysis: Identifying potential interactions between(1hr)

UNIT- III                                                                                                                      12 Hours

Galenicals, its extraction process and    discovery of new chemical entities (NCEs) of Natural origin

• Definition of galenicals and its significance (1hr)
• Different extraction processes like infusion, decoction, maceration, and percolation(1hrs)
• Bring Sustainability into Phytomedicine Research- Use green chemistry techniques for extracting bioactive compounds-Modern method of herbal extraction- Supercritical fluid extraction and microwave assisted extraction (1hr)
• Discovery and development of anti-diabetics, antioxidants, immunomodulating agents, anti-inflammatory agents, anti-viral, antimycobacterial agents and anticancer agents with apoptotic molecular basis (5hrs).
• Clinically available drugs from Natural sources( BioSource, therapeutic uses and approved year): Artemisinin, Digoxin, Diosgenin, Atropine, Taxol, Vincristine and Vinblastine, Reserpine, quinine (2hrs).
• AI-assisted Plant-Based Drug Discovery: Mining Ayurvedic texts and databases to identify bioactive compounds with therapeutic potential(2hrs).

UNIT- IV                                                                                                                     12 Hours

Phytopharmaceuticals

• Definition, Current Trends in Phytopharmaceuticals (1hr)
• Development of a standardized phytopharmaceutical formulation (2hrs)
• Phytopharmaceuticals Regulatory requirements and licensing process (2hrs)
• Role of chemical and biological markers in standardization of herbal products (1hr)
• Veregen® (sinecatechins): A green tea extract approved for the treatment of genital Mytesi™ (crofelemer): Derived from the Croton lechleri plant, approved for managing diarrhea in HIV/AIDS patients. Filsuvez® (birch triterpenes): Approved for the treatment of epidermolysis bullosa, a rare skin disorder. NexoBrid® (anacaulase-bcdb): An enzyme-rich product derived from the pineapple plant, approved for burn debridement (4hrs).
• Research Guidelines for Evaluating the Safety and Efficacy of Herbal products (1hr) List of Assignment topics

1. The regulatory issues of Nutraceuticals and Dietary Supplements as per EU, US, and Indian guidelines. FSSAI, FDA, FPO, MPO, AGMARK. HACCP and GMPs on Food Safety.

2. Pharmacopoeia Specifications for dietary supplements and
3. Effect of processing, storage, and interactions of various environmental factors on the potential of nutraceuticals.
4. Guidelines for herbal drugs and phytopharmaceuticals (USFDA, EMA, AYUSH, WHO). Documentation, patents, and regulatory filings.
5. List of natural products /molecules under clinical trials for various disease condition
6. Plant based products -Dietary supplements / Nutraceuticals- Improving the therapeutic out come & improving the quality of life of patients
7. Drug Controller General of India (DCGI)approval process & Plant derived drugs/ Phytopharmaceuticals category.
8. Central Drugs Standard Control Organization (CDSCO)and approved plant based drugs

SCOPE:

The course is designed to impart knowledge on Complementary and Alternative medicine natural Products and nutraceuticals and their impact on chronic disease prevention. It also discusses essential marketed nutraceuticals that can be appropriately used to improve health and well-being. It also covers the potential drug-drug and drug-herb- interaction and its role in regulation of components of immune system. Free radicals’ impact on chronic disease and their management with antioxidants are also discussed.

The course deals with the various aspects such as extraction of Galenicals and its Extraction Process and discovery of new chemical entities of natural origin. It enables students to learn about Complementary and Alternative medicine natural Products and its safety and effecasy exemplifying with appropriate case studies. The scope extends to understanding the general concept of interactions between herbal drugs and conventional drugs, as well as interactions between herbs and food. Also, harness Artificial Intelligence (AI) tools for plant-based drug discovery and herb-drug interaction analysis, and implement eco-friendly extraction techniques to optimize sustainable phytomedicine development{Sustainable Development Goal 3 (SDG 3-Good Health and Well-being)}. Further more, It explores the scope, regulatory aspects and potential of Phytopharmaceuticals, a new drug class regulated in India. This course ensures a participatory role as responsible citizens and facilitates improvement in health and well-being.

COURSE LEARNING OUTCOMES

Upon successful completion of the course, the student shall be able to;

KNOWLEDGE

 K1: Discuss the various types of CAM Natural products

K2: Compare the various Phytopharmaceuticals and its releveance

K3: Describe the marketed nutraceuticals with their positive health outcome.

K4: List out herbs as health food and their scope in chronic disease prevention.

K5: Outline the the efficacy and safety aspects of CAM natural products

K6:Analyze the possible side effects and interactions of herbal drugs.

SKILL

 S1: Use AI to study plant medicines, its drug interactions and apply green methods to extract plant compounds sustainably.

S2: Compare and contrast CAM natural products and Nutraceuticals

S3: Evaluate the chemical and biological markers in satndardized extracts

S4: Detect the limitations of marketed nutraceuticals

S5: Assess the the antioxidant potential of nutraceuticals.

S6: Apply modern methods for extraction of the herbal drugs.

ATTITUDE

 A1: Upgrade technical, intellectual, and emotional skills and facilitate improvement.

A2: Develop the ability to interact effectively and respectfully with individuals.

A3: Participate autonomously in a technical and supervisory context.

A4: Accept responsibility for self and group work.

A5: Implement plans and organize work to meet deadlines.

A6: Appreciate collaborative skills to work effectively in interprofessional healthcare teams.