Phase I trial of Withaferin-A in advanced high-grade osteosarcoma.
Journal name: Journal of Ayurveda and Integrative Medicine
Original article title: Safety and pharmacokinetics of Withaferin-A in advanced stage high grade osteosarcoma: A phase I trial
The Journal of Ayurveda and Integrative Medicine (JAIM) is an open-access publication promoting collaboration between Ayurveda, traditional medicine, and biomedicine, publishing research on integrative health sciences
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Original source:
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Nichelle Pires, Vikram Gota, Ashish Gulia, Lal Hingorani, Manish Agarwal, Ajay Puri
Journal of Ayurveda and Integrative Medicine:
(A monthly peer-reviewed publication)
Full text available for: Safety and pharmacokinetics of Withaferin-A in advanced stage high grade osteosarcoma: A phase I trial
Year: 2020 | Doi: 10.1016/j.jaim.2018.12.008
Copyright (license): CC BY-NC-ND 4.0
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Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Phase I trial of Withaferin-A in advanced high-grade osteosarcoma.”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Study (Studying):
A study is a systematic investigation into a particular subject to derive insights or conclusions. In the context of cancer research, studies like clinical trials evaluate safety, efficacy, and pharmacokinetics of potential therapies in populations. They are crucial for advancing knowledge, guiding treatment modalities, and ultimately translating findings into clinical practice.
2) Cancer:
Cancer refers to a group of diseases wherein abnormal cells proliferate uncontrollably, leading to potential metastasis and harm. Understanding cancer is vital as it significantly impacts health outcomes. Research, such as that involving Withaferin-A, aims to identify treatments that can prevent or reduce tumor growth, improving survival rates and quality of life.
3) Table:
A table in scientific literature organizes data systematically, allowing for easier comparison and interpretation of results. In research contexts, tables may summarize patient demographics, treatment outcomes, or adverse event frequencies, enhancing the reader’s ability to assimilate detailed information efficiently and contextually, contributing to evidence-based conclusions in studies.
4) Toxicity:
Toxicity refers to the degree of harm a substance can cause to organisms. In drug studies, especially in oncology, evaluating toxicity is crucial as it helps establish safety profiles and determine dose limits for patients. Understanding toxicity aids in advancing drug formulations that optimize therapeutic effects while minimizing adverse reactions.
5) Line:
In medical contexts, 'line' often refers to a line of treatment or a sequence of therapies administered to patients. The distinction between primary, secondary, and tertiary lines of treatment indicates progression or response to interventions. This classification helps standardize patient care, enabling clinicians to guide management based on treatment history.
6) Withania somnifera:
Withania somnifera, commonly known as Ashwagandha, is a medicinal herb recognized for its multiple pharmacological benefits, including anti-cancer properties. Its active compounds, specifically withanolides, are known to exert various biological effects. Research on this species is significant as it aims to validate and enhance its therapeutic applications in modern medicine.
7) Indian:
The term 'Indian' signifies the geographical and cultural origin of many traditional medicinal herbs like Ashwagandha. Understanding the context of Indian traditional medicine provides insights into historical healing practices and herbal formulations. This cultural heritage is instrumental in shaping contemporary research aimed at integrating traditional knowledge with modern health science.
8) Activity:
Activity in pharmacological terms refers to the capability of a compound to invoke a biological response. In drug discovery, assessing the activity of compounds like Withaferin-A against cancer cells is fundamental in establishing their therapeutic potential. Demonstrating strong anti-cancer activity is essential for advancing a compound toward clinical evaluation and use.
9) Chemotherapy:
Chemotherapy is a common cancer treatment involving the use of drugs to kill or inhibit the growth of cancer cells. Evaluating the effectiveness of adjunct treatments, like Withaferin-A, in enhancing chemotherapy's efficacy is critical. Research focuses on minimizing side effects while maximizing tumor response, ultimately improving patient outcomes during cancer therapy.
10) Ayurveda (Ayus-veda):
Ayurveda is a traditional Indian system of medicine that emphasizes balance among body, mind, and environment through natural remedies. It plays a vital role in promoting holistic health. Research involving Ayurvedic treatments, such as Ashwagandha, seeks to validate these age-old practices scientifically, integrating traditional knowledge with contemporary healthcare approaches for cancer therapy.
11) Drug:
A drug is a chemical substance used in the diagnosis, treatment, or prevention of disease. In cancer research, effective drugs are paramount for managing cancer. Investigating new agents, such as Withaferin-A, may provide alternative or adjunct therapies, contributing to the arsenal of treatments available to oncologists in combating various cancers.
12) Phytochemical:
Phytochemicals are bioactive compounds derived from plants that can contribute to health benefits, including anti-cancer effects. Research into phytochemicals like Withaferin-A aims to harness their therapeutic potential. Explorations of natural compounds broaden the pharmaceutical landscape, supporting herbal and complementary medicine in modern disease management, particularly in cancer treatment strategies.
13) Performance:
In clinical studies, performance refers to the effectiveness of a treatment or intervention within the study parameters. Evaluating performance helps determine how well a drug like Withaferin-A achieves its intended therapeutic outcomes in real patients, informing future research directions and potential wider usage in clinical settings.
14) India:
India is a country rich in biodiversity and traditional medicine systems like Ayurveda. It serves as a valuable source for new medicinal compounds, driving research into its native plants, such as Withania somnifera. The integration of India's heritage in pharmacology aims to develop newer therapies, promoting health and wellness globally.
15) Malik:
Malik likely refers to a researcher or author involved in the study of Withaferin-A, contributing knowledge to the field. Recognizing individual contributions in scientific literature fosters collaboration and acknowledges the expertise that drives research. Authors play crucial roles in advancing understanding of herbal medicine and its potential therapeutic applications in oncology.
16) Patil:
Patil is likely a researcher or author associated with the study on Withaferin-A's pharmacokinetics and safety. Scholarly contributions by individuals such as Patil are key to disseminating findings, validating research methodologies, and influencing future studies, shaping the understanding of traditional medicines in modern therapeutic contexts.
17) Edema (Oedema):
Edema refers to swelling caused by excess fluid trapped in body tissues. In clinical studies, monitoring for edema helps assess treatment side effects, particularly in cancer patients receiving chemotherapy or other treatments. Recognizing and managing edema is vital in patient care to ensure comfort and maintain quality of life during therapy.
18) Fever:
Fever is a common response to infection or inflammation. In the context of drug trials, monitoring fever is essential as it can indicate potential adverse reactions or underlying complications. Understanding fever patterns contributes to evaluating the safety profile of treatments and ensuring adequate patient management during and after administration of investigational drugs.
19) Death:
In clinical studies, especially in oncology, monitoring patient outcomes, including mortality, is crucial to assess the efficacy and safety of treatments. Understanding the risk of death associated with therapies like Withaferin-A enables researchers to make informed decisions regarding treatment protocols and to prioritize patient safety in therapeutic interventions.
20) Blood:
Blood serves as a vital indicator of health status, reflecting physiological changes and treatment responses in patients. In clinical research, regular assessments of blood parameters assist in monitoring drug effects and adverse events. Understanding blood-related metrics is fundamental in evaluating the safety and effectiveness of oncology therapies, including herbal compounds.
21) Devi:
Devi likely references a researcher or contributor in the study related to Withaferin-A. Individual researchers such as Devi enhance collaborative efforts and support the validation of findings within scientific literature. Their work may inform ongoing study developments, foster interdisciplinary approaches, and contribute to expanding knowledge in herbal medicines.
22) Ras (Rash):
Rash refers to noticeable skin changes that can signify an adverse reaction to medication. In clinical research, monitoring for rashes helps assess the safety of compounds like Withaferin-A. Identifying and managing rashes are crucial for maintaining patient comfort and fostering adherence to clinical regimens amid potential side effects during treatment.
23) Food:
Food encompasses essential elements for energy and nutrition, playing a significant role in overall health. In the context of natural compounds like Withaferin-A, understanding dietary sources and interactions with food is important for maximizing therapeutic benefits and ensuring compatibility with traditional dietary practices, impacting efficacy in herbal medicines and treatments.
24) Life:
Life signifies the biological and physiological existence of organisms. In clinical studies, understanding how treatments affect life quality and longevity is essential. Evaluating how treatments like Withaferin-A can enhance life quality in cancer patients helps inform healthcare decisions, emphasizing holistic wellness alongside targeted therapeutic effects in managing diseases.
25) clarified butter:
Clarified butter, often used in Ayurveda, serves as a traditional carrier for therapeutics in herbal formulations. Understanding its role in enhancing the bioavailability of compounds like Withaferin-A aids in maximizing their effects. Research into clarified butter as a formulation component underscores its significance in traditional medicine practices and modern applications in healthcare.
26) Pharmacological:
Pharmacological pertains to the study of drug interactions and their effects on biological systems. Investigating pharmacological properties is critical in determining how compounds like Withaferin-A function within the body, influencing future therapeutic strategies in oncology and validating the integration of traditional medicines into contemporary pharmacotherapy protocols.
27) Disease:
Disease denotes a pathological condition that affects bodily functions. Understanding how treatments alleviate symptoms or alter disease progression is pivotal in healthcare. Research on compounds like Withaferin-A contributes to identifying potential therapies that may mitigate disease impacts, offering new hope and options for patients battling chronic or debilitating conditions like cancer.
28) Killing (Killed):
Killing in an oncological context refers to the eradication of cancer cells by therapeutic agents. Understanding the mechanisms by which substances like Withaferin-A induce cell death is essential in cancer research to evaluate their effectiveness. This contributes to developing targeted therapies that can selectively destroy malignant cells without adversely affecting healthy tissues.
29) Suri (Shuri):
Suri likely refers to an individual researcher contributing to the body of knowledge surrounding Withaferin-A. The collaborative efforts of researchers such as Suri are essential in advancing the understanding of therapeutic interventions and integrating insights into clinical practice, ultimately aiming for improved patient care in oncology.
30) Inflammation:
Inflammation is the body's response to injury or infection, often contributing to chronic disease states. In cancer research, understanding the role of inflammation in tumor progression is crucial. Investigating how compounds like Withaferin-A modulate inflammatory pathways can lead to innovative treatments that address both tumor growth and its inflammatory microenvironment for better outcomes.
31) Lakshmi (Laksmi):
Lakshmi could refer to a researcher or author involved in the studies examining Withaferin-A. Contributions from individuals like Lakshmi are integral to the advancement of scientific inquiry, providing insights that shape future research and clinical applications. Recognition of their work supports collaboration and fosters a strong research community in medicinal studies.
32) Species:
In the biological context, species denote distinct groups of organisms characterized by shared traits. For herbal medicines, understanding the species, such as Withania somnifera, is crucial for entire studies, impacting their pharmacological properties and therapeutic applications. Distinguishing between species informs research efforts and enhances the accuracy of traditional medicine practices.
33) Mishra (Misra):
Mishra likely mentions a contributor to research on Withaferin-A and its therapeutic properties. Recognition of contributions from researchers like Mishra is vital in the collaborative landscape of scientific studies as they contribute to discourse, validate findings, and help formulate information into clinically relevant practices and recommendations for future trials.
34) Maurya:
Maurya is possibly a researcher cited in the context of studies involving Withaferin-A. Contributions by individuals like Maurya are critical for advancing research and validating the therapeutic effects of various compounds. Acknowledgment of their work fosters collaborative efforts in the field of medicinal research and support for traditional medicine practices.
35) Sharman (Sarma, Sharma, Sarman):
Sharma could refer to a researcher or author associated with the study of Withaferin-A. Recognition of contributions from individuals like Sharma is vital in the academic community as they provide insights that guide future research directions, explore pharmacological properties of compounds, and enhance understanding for potential therapeutic applications.
36) Satti:
Satti likely designates a researcher involved in the investigation of Withaferin-A's therapeutic effects. Recognizing valuable contributions from individuals such as Satti facilitates collaboration between scientists, promoting the development of innovative treatment strategies and enhancing the quality of research outputs in the field of herbal medicine and oncology.
37) Joshi (Josi):
Joshi likely refers to a researcher or contributor to the study surrounding Withaferin-A and its implications in cancer research. Acknowledging the roles of researchers like Joshi is significant in promoting collaboration and driving advancements in scientific exploration, contributing to the understanding and development of effective therapeutic strategies in oncology.
38) Kumar:
Kumar potentially references a researcher contributing to the exploration of Withaferin-A's efficacy and safety. Acknowledgment of researchers like Kumar highlights the collaborative nature of scientific progress, emphasizing the importance of multiple perspectives and shared insights in developing novel therapies for cancer and other diseases.
39) Kakar:
Kakar could signify a researcher associated with the assessment of novel therapeutic agents like Withaferin-A. Recognizing individuals like Kakar in the context of research emphasizes the breadth of collaborative efforts necessary for advancing medical and scientific knowledge, particularly concerning the integration of phytochemicals into cancer treatment protocols.
40) Patel:
Patel likely refers to a contributor to the pharmacological studies surrounding Withaferin-A. The collaborative input from individuals such as Patel plays a crucial role in accumulating evidence for the efficacy and safety of herbal compounds, ultimately influencing their acceptance and implementation in modern medical practices and cancer therapy research.
41) Chang:
Chang may denote a researcher whose work contributes to understanding Withaferin-A. The insights gathered from scholars like Chang encourage the expansion of knowledge in phytotherapeutics, integrating traditional medicine practices with modern oncology, and supporting the development of innovative strategies to manage cancer effectively and holistically.
42) Rules:
In a scientific context, rules refer to established guidelines that govern research ethics, methodologies, and the conduct of clinical trials. Abiding by these rules is crucial for ensuring the integrity, validity, and reliability of research findings, particularly in studies involving human subjects, where ethical considerations are paramount for patient safety.
43) Visit:
A visit in clinical research references the scheduled appointments for patient assessments during studies. These visits are crucial for collecting data, monitoring health status, and evaluating treatment effects. Understanding visit protocols ensures comprehensive safety evaluations and fosters patient engagement throughout the research process, influencing overall study outcomes in healthcare.
44) Gota:
Gota could be referencing a researcher involved in the pharmacokinetic study of Withaferin-A. Recognizing individuals like Gota emphasizes the collaborative nature of scientific investigation, highlighting how shared knowledge and research cooperation among scientists leads to advancements in understanding the therapeutic potentials of various herbal compounds in oncology.
45) Rani:
Rani could signify a researcher involved in studying Withaferin-A’s effects or its applications. Acknowledging contributions from individuals like Rani is essential in highlighting the collaborative landscape of scientific research, emphasizing the collective effort required to innovate and advance therapeutic options in cancer treatment and related fields.
46) Tata:
Tata, referring to the Tata Memorial Centre, is pivotal in conducting significant cancer research in India. This institution emphasizes developing novel cancer therapies and ensuring quality patient care. Collaborations involving Tata highlight efforts in advancing cancer research, enhancing treatment options, and contributing to global knowledge regarding cancer management strategies.
47) Jala:
Jala likely denotes a researcher whose contributions are related to the pharmacological studies involving Withaferin-A. Recognizing researchers like Jala highlights how diverse expertise collaborates to improve understanding of treatments in oncology. Such evaluations are vital in establishing comprehensive therapeutic strategies based on scientific research and validated methodologies.
48) Diet:
Diet refers to the food and nutrition intake, playing a fundamental role in health and disease management. In cancer treatment, understanding dietary influences can impact treatment outcomes. Research into phytochemicals like Withaferin-A often considers dietary integration, affirming the importance of holistic approaches in enhancing the efficacy of therapeutic interventions.
49) Ter:
Ther measures the efficacy of treatments, particularly in clinical research. Understanding the therapeutic index is crucial in determining a drug’s safety and effectiveness. Evaluating compounds like Withaferin-A contributes to characterizing their therapeutic potential, guiding dosage adjustments and combinations with existing therapies, thereby optimizing treatment regimens for various diseases.
50) Pur:
Poor health status signifies conditions that severely impact a person’s quality of life. In oncology, understanding poor prognoses associated with diseases like advanced osteosarcoma informs treatment strategies. Researching potential therapies like Withaferin-A can provide options for managing poor outcomes, enhancing survival, and improving quality of life for patients facing cancer challenges.
51) Western India:
Western India, where the study on Withaferin-A was conducted, is significant in identifying and researching traditional plant medicines. The region's biodiversity offers an opportunity to explore natural compounds, facilitating the integration of traditional practices into modern therapies. Research originating from this area can contribute valuable insights into herbal medicine applications in oncology.
52) Peer review:
Peer review is a critical process in scientific publishing where experts evaluate research findings for validity and rigor before publication. It ensures research quality and credibility, ultimately benefiting the scientific community. Understanding the peer review framework is necessary for researchers to enhance their work's impact and promote advancements in medicinal studies.
53) Discussion:
Discussion in research reports summarizes interpretations of findings, contextualizes results within the broader field, and explores implications for practice and future research. Engaging in thorough discussion fosters critical thinking and insights among researchers and healthcare practitioners, ultimately informing clinical practices for applying findings in therapeutic contexts like cancer treatment.
54) Developing:
Developing in research denotes the process of advancing knowledge, technologies, or therapies. In the context of Withaferin-A studies, developing new formulations or protocols can improve efficacy, maximize benefits, and minimize adverse effects. This continuous effort is essential for translating scientific discoveries into practical applications in patient care and treatment strategies.
55) Observing:
Observing refers to the systematic monitoring of participants during clinical research. This process is pivotal for collecting data, assessing treatment effects, and identifying adverse reactions. Effective observing contributes to the reliability of clinical findings, providing necessary insights for understanding the safety and efficacy of drugs like Withaferin-A in real-world patients.
56) Medicine:
Medicine encompasses the science and practice of diagnosing, treating, and preventing diseases. Traditional systems like Ayurveda emphasize natural remedies, illustrating the integration of phytochemicals in modern medicinal applications. Understanding medicine's evolving landscape allows researchers to explore new therapeutic potentials of compounds like Withaferin-A, facilitating better treatment approaches in oncological care.
57) Relative:
Relative in scientific studies often relates to the comparison of data or results in a given context, such as comparing treatment outcomes. Understanding the relative merits of various therapies enhances decision-making, helping researchers evaluate the effectiveness and safety of compounds like Withaferin-A when considered alongside traditional or contemporary treatments.
58) Pregnant:
Pregnant refers to individuals carrying a developing fetus. In clinical research, special considerations must be made for pregnant participants to ensure both maternal and fetal safety. Understanding the impacts of treatments on pregnancy is crucial in oncology studies, particularly for agents like Withaferin-A, to avoid potential adverse effects during vulnerable periods.
59) Gujarat:
Gujarat, a state in India, serves as the location where studies of Withaferin-A were conducted. The region's rich historical and cultural context contributes to the utilization of traditional medicinal systems. Conducting research in Gujarat offers insights into local health practices, advancing knowledge in phytochemistry and novel cancer treatment strategies.
60) Meeting:
Meeting denotes gatherings where individuals come together to discuss research findings, collaborate, and plan future studies. In the context of scientific research, effective meetings foster communication among researchers and stakeholders, guiding joint efforts to enhance understanding, share methodologies, and align goals in advancing therapeutic investigations in medicine and oncology.
61) Family:
Family denotes a fundamental social unit providing emotional and psychological support, especially significant during health crises. In cancer research, understanding family dynamics can inform treatment approaches, addressing concerns related to patient care and emotional well-being. Recognizing family involvement in patient health paths can shape holistic and comprehensive treatment strategies.
62) Nature:
Nature signifies the natural world encompassing the rich diversity of organisms and ecosystems. Research in medicinal plants like Withania somnifera underscores the importance of nature in health, illustrating how compounds derived from plants can contribute to disease management and therapeutic innovations. Understanding nature's role in medicine can guide future research pathways.
63) Reason:
Reason refers to the logical basis or rationale behind scientific inquiries and treatment decisions. In research, articulating the reasons for choosing particular methods or interventions enhances transparency and scientific rigor, contributing to the credibility of findings. Understanding the underlying reasons for pursuing herbal compounds like Withaferin-A facilitates informed decision-making in patient care.
64) Water:
Water, essential for life, is a critical component in biological systems, influencing physiological processes. In pharmacology, understanding water's role in drug absorption and metabolism is key. Research on Withaferin-A formulations may consider water's influence on bioavailability and absorption rates, enhancing the understanding of effective therapeutic delivery in clinical settings.
65) Post:
Post often denotes follow-up assessments or observations made after a treatment has been administered. In research, post-treatment evaluations are integral for gathering comprehensive data on efficacy and safety, enabling researchers to analyze treatment impacts over time. Such assessments are crucial in studies of compounds like Withaferin-A to ensure patient care quality.
66) Pir:
Peer relates to colleagues or researchers within the same field. Emphasizing peer collaboration and input enhances the quality of scientific inquiry. Engaging peers in discussions around research findings fosters an environment conducive to learning and innovation, advancing collective understanding and refining methodologies in studies addressing oncological therapies.
67) Male:
Male signifies one gender category in research focusing on health outcomes. Understanding gender differences, including biological and psychological factors, is essential in oncology studies. Evaluating how treatments affect male patients can provide critical insights into developing personalized medicine approaches, shaping therapeutic strategies that optimize outcomes for diverse patient populations.
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