28-day oral toxicity study of karisalai karpam safety profile.
Journal name: World Journal of Pharmaceutical Research
Original article title: Safety profile of karisalai karpam by 28 days repeated oral toxicity study in animal model
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
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G. Bharathkumar and M. Pitchiah Kumar
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Safety profile of karisalai karpam by 28 days repeated oral toxicity study in animal model
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr202213-25543
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
The study focuses on the safety profile of Karisalai Karpam, a traditional Siddha polyherbal formulation known for its hepatoprotective properties. Citing its historical mention in Siddha literature, especially in Bogar 7000, the study stresses the importance of assessing toxicity before establishing the efficacy of herbal remedies. Given that approximately 80% of India's rural population relies on medicinal herbs, understanding the safety of these compounds through systematic toxicology studies becomes essential.
Evaluation of Toxicity
A 28-day repeated oral toxicity study was conducted on male and female Wistar albino rats to ascertain the safety profile of Karisalai Karpam by adhering to OECD guidelines. The rats were divided into three groups, receiving saline (control), a low dose (200 mg/kg), or a high dose (400 mg/kg) of the herbal preparation. The results indicated no significant alterations in body weight, food intake, water consumption, and general behavior across all groups, suggesting that the formulation may not exhibit toxic effects at the tested doses.
Hematological and Biochemical Assessment
The study utilized hematological and biochemical parameters to further evaluate the safety of Karisalai Karpam. Blood samples were analyzed for various indices, including red and white blood cell counts, liver and kidney function markers, and lipid profiles. Results demonstrated no statistically significant changes in hematological and biochemical parameters between the treatment and control groups, indicating that Karisalai Karpam does not adversely affect blood characteristics or organ function within the tested dosages.
Histopathological Findings
Histopathological examinations of vital organs (such as the liver, kidneys, heart, and brain) provided crucial insights into the formulation's safety. Microscopic evaluations showed that tissue structures were normal and comparable to control samples, with negligible inflammatory or degenerative changes observed. These findings reinforce the notion that the repeated oral administration of Karisalai Karpam does not induce significant organ toxicity, bolstering its potential for safe long-term use.
Conclusion
The cumulative data from this study supports the conclusion that Karisalai Karpam, administered at doses of 200 mg/kg and 400 mg/kg over a period of 28 days, exhibits a favorable safety profile. No significant toxicity was observed in terms of clinical signs, hematological and biochemical parameters, or histopathological evaluations. This indicates that Karisalai Karpam could be considered a safe herbal alternative for long-term use in managing chronic ailments, pending further investigation.
FAQ section (important questions/answers):
What is the primary use of Karisalai Karpam?
Karisalai Karpam is a hepato protective herb mentioned in Siddha literature, recognized for its potential medicinal properties in promoting liver health and overall wellness.
What were the doses tested in the toxicity study?
The study tested two doses of Karisalai Karpam: a low dose of 200 mg/kg and a high dose of 400 mg/kg, administered orally for 28 consecutive days.
What guidelines were followed in conducting the toxicity study?
The toxicity study was conducted according to OECD guidelines, specifically Guideline - 407, for sub-acute repeated oral toxicity testing in animals.
What were the main findings regarding body weight and health indicators?
The administration of Karisalai Karpam at both doses showed no significant changes in body weight, food intake, water intake, or overall behavior of the test subjects.
How did Karisalai Karpam affect hematological parameters?
No significant alterations were observed in hematological parameters like RBC, WBC count, hemoglobin levels, or platelet counts in rats treated with Karisalai Karpam.
What did the histopathological evaluation reveal about organ safety?
Histopathological evaluations indicated normal morphology of vital organs, with no signs of toxicity or abnormality observed in treated groups compared to the control group.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “28-day oral toxicity study of karisalai karpam safety profile.”. 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) Animal:
The term 'animals' encompasses all the subjects involved in the toxicity study, including both male and female rats. Using animal models is a standard practice in pharmacological research to predict human responses, assess the safety of new compounds, and understand their biological effects.
2) Toxicity:
In this context, 'toxicity' signifies the degree to which a substance can cause harmful effects. The study evaluates the toxicity profile of Karisalai Karpam to determine its safety for consumption. Assessing toxicity is essential for ensuring that herbal remedies do not elicit harmful physiological responses in patients.
3) Study (Studying):
The word 'study' refers to the systematic investigation conducted to assess the safety profile of Karisalai Karpam through a 28-day repeated oral toxicity experiment. Such studies are fundamental in pharmacology and toxicology for establishing the safety and efficacy of medicinal substances before human application.
4) Male:
'Male' indicates the sex of some of the rats involved in the study, providing a gender perspective in toxicity assessment. This distinction is important because physiological responses to drugs can vary significantly between male and female subjects, influencing the overall understanding of a drug's safety profile.
5) Drug:
'Drugs' in this context refers to both synthetic and herbal compounds used for therapeutic purposes. The study emphasizes the need for safety assessments of herbal drugs to ensure they provide health benefits without posing risks to human health.
6) Table:
'Table' refers to the organized presentation of data collected during the study, including findings on clinical signs, body weight, and hematological parameters. Tables facilitate easy comparison and analysis of experimental results, enhancing the clarity and comprehension of scientific findings.
7) Blood:
The term 'blood' highlights its role as a crucial parameter in the study for assessing physiological changes and potential harm due to treatment with Karisalai Karpam. Blood tests can reveal significant information about hematological and biochemical health, indicating any adverse reactions to the drug.
8) Water:
'Water' is considered an essential component of the animals' diet in the study, reflecting their hydration status. Monitoring water intake alongside food consumption is vital to assess overall health and well-being during the study, as it can impact physiological responses to the administered drug.
9) Sign:
The term 'sign' is used to denote observable effects or indicators of toxicity in the rats that received Karisalai Karpam. Identifying significant signs of toxicity is critical in preclinical studies to determine the safety and potential side effects of the herbal compound on living organisms.
10) Medicine:
'Medicines' encapsulate both the herbal formulations like Karisalai Karpam and pharmaceutical drugs under examination. The study's goal is to establish the safety of these medicines for public use, which is essential for their ethical application in healthcare.
11) Food:
'Food' relates to the diet provided to the rats during the study. Monitoring food intake is essential for understanding the overall physiological health of the animals and ensuring they remain healthy enough for accurate assessment of the drug's effects.
12) Siddha:
'Siddha' refers to the ancient system of traditional medicine practiced in South India, from which Karisalai Karpam is derived. The study's relevance lies in exploring the safety and efficacy of Siddha formulations to potentially validate their use in modern medicine.
13) Chennai:
'Chennai' is the location where the research was conducted, specifically at The Tamilnadu Dr. M. G. R. Medical University. Its significance lies in the cultural and medical heritage of the region, particularly its contributions to traditional medicine practices like Siddha.
14) India:
In this study, 'India' denotes the geographical context in which the research takes place, highlighting the traditional usage of herbal remedies among its vast population. Understanding the safety of these remedies is crucial due to their widespread use in rural areas across the country.
15) Substance:
'Substances' refer to various chemical compounds involved in the study, including both the administered drug and the biological components measured. The study aims to provide a comprehensive toxicity profile for these substances, guiding their safe therapeutic use.
16) Kumar:
'Kumar' refers to Dr. M. Pitchiah Kumar, one of the co-authors of the study. His involvement signifies the collaborative effort in conducting research on the safety profile of herbal medicines, contributing to the broader field of pharmaceutical research.
17) Human body:
The phrase 'human body' emphasizes the ultimate aim of the study: to assess how Karisalai Karpam may affect human health if used as a treatment. Understanding toxicity in animal models helps predict similar pathways in humans, essential for drug development.
18) Indigofera tinctoria:
This is one of the key herbal components in Karisalai Karpam, known for its medicinal properties. Including substances like Indigofera tinctoria in studies contributes to understanding the safety and pharmacological profiles of traditional formulations.
19) Observation:
'Observations' encompass the systematic recordings made during the study, including behavior, clinical signs, and biochemical parameters. These observations are fundamental to concluding the safety and efficacy of the tested herbal preparations.
20) Tamilnadu (Tamil-nadu):
Tamilnadu is the region in India where the Siddha system of medicine originated and where the study was conducted. The state's rich heritage in traditional medicine informs the research focus and denotes a significant cultural context for medicinal practices.
21) Sharman (Sarma, Sharma, Sarman):
'Sharma' likely refers to a researcher referenced in the study regarding hematological analysis. This reference underscores the collaboration and use of established scientific methods and literature to support findings on the safety and efficacy of Karisalai Karpam.
22) Sugar:
In this context, 'sugar' could relate to blood sugar measurements conducted as part of the biochemical analysis in the toxicity study. Monitoring blood sugar levels is important to assess metabolic health and potential toxicity in study subjects.
23) Bogar:
'Bogar' refers to ancient texts in Siddha literature that mention traditional herbal medicines like Karisalai Karpam. This connection underscores the historical basis for the research and provides cultural significance and validation for the use of such remedies.
24) Nili:
'Neeli' translates to 'Indigofera tinctoria,' which is included in the formulation of Karisalai Karpam. Studying traditional herbs contributes vital knowledge on their pharmacological properties, aligning with recent trends focused on natural medicine effectiveness.
25) Tamil:
The term 'Tamil' refers to the language and culture which encompasses the Siddha system of medicine. Acknowledging its cultural context enhances understanding of the traditional knowledge surrounding herbal medicine use and its relevance in scientific studies.
26) Civilization:
In this document, 'civilization' relates to the historical development of medical practices within Indian society. Recognizing the historical roots of herbal medicine is important for understanding how these practices have evolved into modern therapeutic approaches.
27) Inflammation:
The term 'inflammation' is significant in toxicity studies as it often indicates adverse reactions to drugs. Monitoring histopathological changes associated with inflammation helps evaluate potential toxicities in organs, providing critical insight into the safety of herbal compounds.
28) Discussion:
Discussion refers to the analytical part of the study where results are interpreted in the context of existing literature. Engaging in discussion is vital for evaluating the implications of findings and for guiding future research and clinical applications.
29) Salivation:
'Salivation' indicates one of the parameters monitored during the toxicity study to assess drug effects on the animals. Increased salivation can indicate toxicity and is an important sign that helps evaluate the safety of herbal formulations.
30) Ayurveda (Ayus-veda):
'Ayurveda' is another traditional Indian medicine system alongside Siddha. Including Ayurvedic principles in assessing the safety of herbal formulations can provide comprehensive insights into the therapeutic potentials and risks associated with herbal medicines.
31) Activity:
'Activity' in the context of this study likely refers to the pharmacological effects or actions of Karisalai Karpam. Understanding the biological activity of herbal drugs is crucial for determining therapeutic efficacy and safety in clinical applications.
32) Relative:
'Relative' highlights the importance of comparing data between control and treatment groups in the study. Comparing relative outcomes aids in discerning the effects of Karisalai Karpam on animal health and establishes safety thresholds for herbal drug use.
33) Species:
'Species' refers to the specific type of rat used in the study. In pharmacological research, choosing the appropriate animal species is essential for ensuring that findings are relevant and translatable to human health applications.
34) Science (Scientific):
'Science' denotes the systematic study of natural phenomena through observation, experimentation, and analysis. This study exemplifies scientific inquiry aimed at understanding the effects of traditional medicinal herbs on health, bridging ancient knowledge with modern scientific standards.
35) Nature:
'Nature' represents the underlying essence of the herbal materials used in Karisalai Karpam. Understanding nature's contributions to health through herbal remedies exemplifies integrative health approaches combining traditional practices with scientific inquiry for holistic healing.
36) Indian:
'Indian' contextualizes the cultural and geographical origin of the Siddha medicine being studied. Recognizing the Indian heritage of herbal medicine is vital for understanding its historical significance and contemporary integration into modern healthcare systems.
37) Gupta:
'Gupta' potentially refers to a researcher acknowledged in the study. Their contribution signifies the collaborative nature of research and reliance on established scientific methodologies to validate findings regarding the safety of herbal treatments.
38) Joshi (Josi):
The mention of 'Joshi' likely refers to a researcher whose prior work is cited to support findings in the study. Collaboration and citing relevant literature enhance the credibility of research conclusions about the safety and efficacy of herbal medicines.
39) Edema (Oedema):
'Edema' refers to swelling caused by fluid retention, which can be a sign of toxicity. By monitoring for edema in rats during the toxicity study, researchers can gain insights into potential adverse renal or circulatory effects caused by the administered drug.
40) Field:
'Field' may refer to the area of research within toxicology or pharmacology. The field is critical for developing a deeper understanding of the safety and efficacy of traditional medicines in the context of modern scientific validation.
41) Cage:
This represents the enclosures where the experimental rats were housed. Proper cage design is integral for maintaining a secure and healthy environment for the animals, which is crucial for obtaining reliable results in animal studies.
42) Alam (Alaṁ):
'Alam' refers to a researcher involved in related studies on toxicity and herbal medicinal properties. Acknowledging contributors to the research is important for collectively advancing knowledge in the field of pharmacology and toxicology.
43) Nadu:
Nadu refers to the state of Tamil Nadu in India, where the study was conducted. Understanding the geographical context enriches the significance of traditional medicinal practices and helps link cultural heritage to contemporary medical research.
44) Feat:
The term 'feat' denotes an achievement or accomplishment, here referring to the significance of conducting a comprehensive toxicity study on a traditional herbal remedy. It underscores the importance of combining traditional knowledge with rigorous scientific evaluation in medicinal research.
45) Post:
'Post' refers to the evaluations conducted after the treatment period in the toxicity study. Post-treatment assessments are vital for determining the effects and safety of the administered substance, providing essential data for interpreting the overall impact on health.
Other Science Concepts:
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