Acute oral toxicity study of Narkaranthai Legium in Wistar rats.
Journal name: World Journal of Pharmaceutical Research
Original article title: Acute oral toxicity study of siddha drug narkaranthai legium in female wistar rats
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A. Janakiram, A. F. Glara and Prof. Dr. S. Kaniraja
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Acute oral toxicity study of siddha drug narkaranthai legium in female wistar rats
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr20192-14170
Copyright (license): WJPR: All rights reserved
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Summary of article contents:
Introduction
Narkaranthai Legium (NKL) is an herbal formulation from the Siddha system of traditional medicine, specifically referenced in the Brahma muni karukidai soothiram 380, primarily used in the treatment of psoriasis. Psoriasis is a chronic autoimmune disease characterized by red, dry, itchy, and scaly patches on the skin, which can vary in severity. This study aimed to evaluate the safety and efficacy of NKL through acute oral toxicity testing on female Wistar rats, following OECD guideline 423.
Non-Toxic Nature of Narkaranthai Legium
The acute toxicity study involved administering various doses of NKL (500 mg, 1000 mg, 2000 mg, 4000 mg, and 6000 mg per kg body weight) to groups of female Wistar rats. Throughout the observation period of 14 days, the study noted no significant adverse effects or mortality at any dosage. The findings indicated that NKL is non-toxic, establishing a No-Observed-Adverse-Effect Level (NOAEL) of 6000 mg/kg. Continuous monitoring revealed that the animals showed no signs of toxicity, supporting the safety profile of this Siddha formulation.
Methodology of the Study
The methodology encompassed thorough preparation and purification of the herbal ingredients as outlined in traditional Siddha texts. The administration of NKL was conducted via oral gavage, using distilled water as the vehicle. The experimental setup was crucial for controlling variables, including environmental conditions such as room temperature and humidity. Careful observation parameters were established to assess any physical and behavioral changes in the rats over the study period.
Observations and Histopathological Examination
During the observation period, parameters such as alertness, grooming, and pain response were evaluated. The results indicated normal responses across all observational categories, with no signs of distress or abnormal behavior in the treated groups. Histopathological examinations of the lungs, liver, spleen, and kidneys showed no significant adverse changes. The overall health of the rats remained stable, reinforcing the non-toxic impact of NKL at the administered doses.
Conclusion
The study concludes that Narkaranthai Legium, administered in single doses ranging from 500 mg to 6000 mg/kg, poses no toxic risk in female Wistar rats. The results suggest that this Siddha herbal formulation is safe and could be considered for further scientific evaluation regarding its efficacy and potential therapeutic applications in treating psoriasis and related skin conditions. The established NOAEL reinforces NKL's non-toxic profile, warranting future studies to explore its clinical benefits in humans.
FAQ section (important questions/answers):
What is Narkaranthai Legium used for in Siddha medicine?
Narkaranthai Legium (NKL) is used in Siddha medicine primarily for the treatment of psoriasis, an autoimmune disease characterized by red, dry, itchy, and scaly skin patches.
How was acute oral toxicity of NKL studied in rats?
The acute oral toxicity study was conducted on female Wistar rats following OECD guideline 423, administering NKL in doses of 500mg, 1000mg, 2000mg, 4000mg, and 6000mg, monitoring them for toxicity effects for 14 days.
What were the main findings regarding the toxicity of NKL?
The study found that Narkaranthai Legium did not induce toxicity or mortality in female Wistar rats at doses up to 6000mg/kg, indicating it is non-toxic in acute toxicity evaluations.
What parameters were observed during the toxicity study?
Observation included clinical signs, behavior changes, body weight, food consumption, and various reflex responses, with no significant abnormalities noted throughout the study period.
What is the No-Observed-Adverse-Effect Level (NOAEL) for NKL?
The No-Observed-Adverse-Effect Level (NOAEL) for Narkaranthai Legium was determined to be 6000 mg/kg, indicating it is safe for the studied doses.
How were the herbal ingredients for NKL prepared?
The herbal ingredients for Narkaranthai Legium were authenticated, purified, powdered, and mixed according to traditional Siddha practices detailed in historical texts, ensuring quality and efficacy.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Acute oral toxicity study of Narkaranthai Legium in Wistar rats.�. 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):
In the context of this research, 'study' refers to the systematic investigation conducted to evaluate the safety of Narkaranthai Legium through an acute oral toxicity assessment in female Wistar rats. This involves carefully observing any adverse effects after administering specified doses of the drug to ascertain its safety profile for potential human use.
2) Toxicity:
Toxicity is the degree to which a substance can cause harm to living organisms. In this study, the focus is on evaluating the acute toxicity levels of Narkaranthai Legium, which is crucial for determining safe dosage limits for future clinical trials and ensuring the formulation doesn't pose health risks to patients.
3) Siddha:
Siddha is a traditional system of medicine originating from South India, known for its holistic approaches and herbal formulations. Narkaranthai Legium, the subject of this study, falls under Siddha medicine, which combines various herbal and mineral components aimed at treating specific ailments, especially skin diseases like psoriasis.
4) Animal:
In plural form, 'animals' encompasses all the Wistar rats involved in the acute toxicity study. The welfare and health monitoring of these animals are central to the research process, ensuring that any observed effects are accurately attributed to the administered drug and not influenced by external factors.
5) Drug:
Drugs generally refer to specific chemical or herbal substances used to diagnose, treat, or prevent diseases. In this study, the focus is on Narkaranthai Legium as a drug, highlighting the need to ascertain its safety in a preclinical setting before human application.
6) Observation:
Observation is a key component of this study, involving detailed monitoring of the Wistar rats after drug administration. Observers note any physical or behavioral changes during the 14-day period to assess the drug's safety, effectiveness, and any potential side effects or adverse reactions.
7) Medicine:
Medicines encompass a broad range of therapeutic agents, including synthetic drugs and herbal formulations like Narkaranthai Legium. This study contributes to the understanding of herbal medicines from Siddha traditions, emphasizing the need for safety assessments for integrating such treatments in modern healthcare.
8) Water:
Water is a critical component during the administration of Narkaranthai Legium. It serves as the vehicle for delivering the drug orally to the rats. Ensuring proper hydration and using adequate amounts of water helps standardize the dosing process during research experiments.
9) Food:
Food is an integral aspect of the rats' care in this study. The animals are provided standard laboratory food pellets, ensuring they receive adequate nutrition during the study period. Their food consumption is monitored to evaluate the impacts of Narkaranthai Legium on their overall health.
10) Inflammation:
Inflammation is a biological response linked to skin conditions like psoriasis, which Narkaranthai Legium aims to treat. The study monitors for signs of inflammation in tissue during toxicity assessments to discern any adverse effects that the herbal formulation may have on the body.
11) Brahmamuni (Brahma-muni):
Brahma-muni is a revered figure in the Siddha tradition, credited with many ancient medicinal texts. The formulation of Narkaranthai Legium is based on teachings from the text attributed to Brahma-muni, indicating the cultural and historical significance of the preparation within traditional medicine.
12) Salivation:
Salivation is one of the parameters monitored during toxicity studies as it may indicate adverse reactions to a drug. In this study, researchers observe any changes in salivation among the rats after administering Narkaranthai Legium which may signal potential toxicity.
13) Activity:
Activity refers to the general behavioral movements and responses of the rats observed during the study. Changes in activity levels post-administration of Narkaranthai Legium can provide insights into the drug's effect on both physical and neurological health of the test subjects.
14) Mineral:
Minerals are naturally occurring elements included in Narkaranthai Legium preparation. Their presence enriches the formulation, offering additional health benefits and enhancing the overall efficacy against diseases. Understanding how minerals contribute to herbal formulations is vital in traditional medicine research.
15) Jaggery:
Jaggery is traditionally used in Siddha formulations for its health benefits. In the preparation of Narkaranthai Legium, jaggery serves as a sweetening agent, enhancing taste while also potentially contributing nutritional benefits associated with natural sugars and minerals found in jaggery.
16) Brahma:
Brahma refers to the divine figure in Hinduism associated with creation. In this context, it represents the traditional authenticity and spiritual integration of Siddha medicine practices, linking to the sacred aspects of the knowledge that informs the preparation and use of herbal formulations like Narkaranthai Legium.
17) Gold (Golden):
Golden describes the color change during the preparation of specific herbs, emphasizing their proper preparation for efficacy. For example, some ingredients in Narkaranthai Legium are fried to a golden color, which can indicate readiness, enhance medicinal properties, and optimize bioavailability.
18) Tamil:
Tamil is the language and cultural context from which the Siddha system of medicine originates. The significance of Tamil is profound as it reflects the linguistic and cultural heritage informing the recipes, practices, and philosophical principles underlying herbal medicine formulations such as Narkaranthai Legium.
19) Muni:
Muni, often referring to a sage or enlightened being in the Indian tradition, contributes to the reverence of ancient practices and texts. In the context of this study, it underlines the integration of spiritual and empirical knowledge that characterizes Siddha medicine, as seen in the teachings of Brahma-muni.
20) Sign:
Sign refers to any observable indicator of effect observed during the study, be it behavioral, physiological, or pathological. Monitoring for signs of toxicity is crucial in determining the safety of Narkaranthai Legium, as meaningful signs can inform necessary adjustments or precautions before human trials.
21) Terminalia chebula:
Terminalia chebula is one of the botanicals in the formulation of Narkaranthai Legium. Known for its medicinal properties, this herb is traditionally used in Ayurveda and Siddha to treat various ailments. Its inclusion likely contributes to the therapeutic potential of NKL.
22) Piper longum:
Piper longum, another ingredient in Narkaranthai Legium, is valued in traditional medicine for its properties to enhance digestion and improve respiratory ailments. Investigating its effects within the formulation is essential to understanding how it contributes to the overall efficacy and safety of the herbal preparation.
23) Terminalia bellirica:
Terminalia bellirica is a key herbal component of Narkaranthai Legium, known for its medicinal benefits. Its use in traditional practices indicates its relevance in treating conditions like psoriasis. Understanding its effectiveness and safety profiles complements the research objective of this acute toxicity study.
24) Acorus calamus:
Acorus calamus is another herb utilized in Narkaranthai Legium preparation. It is traditionally celebrated for digestive and cognitive benefits, demonstrating the intricate combination of various herbal elements in Siddha treatments. Its inclusion in the formulation is aimed at enhancing overall therapeutic effectiveness.
25) Tirunelveli:
Thirunelveli is a town in Tamil Nadu, India, where the raw materials for Narkaranthai Legium were sourced. The local geography influences the availability and authenticity of traditional herbal medicines, making this location significant in preserving and practicing Siddha medical traditions.
26) Tamilnadu (Tamil-nadu):
Tamil Nadu is a state in India known for its rich tradition of Siddha medicine. This region's cultural heritage shapes the practices, methodologies, and formulations within traditional medicine, making it an essential locale for studies like the one assessing the safety of Narkaranthai Legium.
27) Pregnant:
Pregnant refers to female animals that might carry offspring. In this study, only nulliparous and non-pregnant female Wistar rats were chosen to eliminate variables related to pregnancy that could affect the outcomes of toxicity assessments, ensuring a more controlled research environment.
28) Chennai:
Chennai is the capital city of Tamil Nadu, where the National Institute of Siddha is located. The city is significant for advancing research within traditional medicine, providing necessary infrastructure for studies and promoting the integration of Siddha practices into contemporary healthcare.
29) Heating:
Heating is a critical process in the preparation of herbal formulations like Narkaranthai Legium. It is employed to enhance the bioavailability and potency of the ingredients, making it a key factor in ensuring the efficacy of the medication when administered to patients.
30) Disease:
Diseases refer to pathological conditions that require treatment, such as psoriasis which Narkaranthai Legium is intended to relieve. Identifying effective treatments in traditional medicine is essential for expanding therapies available to patients suffering from chronic skin conditions.
31) Milagu:
Milagu, or black pepper, is included in the Narkaranthai Legium preparation. Known for its effects on digestion and its anti-inflammatory properties, Milagu enhances the formulation's therapeutic profile, supporting overall health and effectiveness against conditions treated in Siddha medicine.
32) Cukku:
Chukku, or dried ginger, is another key ingredient in Narkaranthai Legium and is traditionally used for its health benefits, including anti-inflammatory and digestive properties. Understanding its role within the formulation will provide insights into the synergistic effects of components in treating psoriasis.
33) Pattam:
Patham refers to the traditional method of preparing herbal formulations as per Siddha medicine. This process ensures that each component is appropriately prepared and combined to maximize therapeutic effects. Adhering to these traditional methods is crucial for maintaining efficacy and safety in treatments.
34) Sugar:
Sugar, as utilized in the formulation, helps to improve the palatability of Narkaranthai Legium. The use of natural sources of sugar contributes to overall flavor enhancement, which can be significant in patient compliance, especially when administering herbal medications or supplements.
35) Honey:
Honey is frequently used in traditional medicines for its beneficial properties, including antimicrobial effects and its role as a natural sweetener. Its inclusion in Narkaranthai Legium not only enhances taste but also supports the overall health benefits associated with the formulation.
36) Rasa (Rasha):
Rasa, in the context of Siddha medicine, can refer to the essence or taste of a formulation. Understanding the rasas of ingredients in Narkaranthai Legium may also provide insights into the holistic effects of the preparation on health and wellness.
37) Cage:
Cage refers to the housing of the laboratory rats during the acute toxicity study. Proper caging ensures a controlled environment for the animals, which is critical for maintaining their health and for accurate observation of behavioral and physiological responses during the study.
38) Ghi (Ghee):
Ghee, or clarified butter, is another component in Narkaranthai Legium known for its health benefits in traditional cooking. Its inclusion in the formulation is aimed at enhancing the absorption of active ingredients and providing nourishment to the medicinal blend.
39) Zingiber officinale:
Zingiber officinale, or ginger, is included in the Narkaranthai Legium formulation. Recognized for its antioxidant and anti-inflammatory properties, its role in the study is significant in understanding how it contributes to the overall therapeutic benefits of the formulation against psoriasis.
40) Rock salt:
Rock salt is included in the formula for its potential health benefits and flavor enhancement. It plays a role in balancing electrolytes in the body, thus serving a dual purpose in Narkaranthai Legium by enhancing both its medicinal properties and taste.
41) Plumbago zeylanica:
Plumbago zeylanica is another herbal component of Narkaranthai Legium, used traditionally for its medicinal properties. Its integration into the formulation underscores the importance of diverse plant sources in Siddha medicine and reflects the holistic approach taken toward treating various ailments.
42) Pharmacology:
Pharmacology is the branch of medicine that focuses on drug actions and effects. This study incorporates principles of pharmacology to investigate the safety and effects of Narkaranthai Legium, establishing a scientific basis for its usage in treating psoriasis in humans.
43) Purification:
Purification refers to the process of preparing each herb and mineral in Narkaranthai Legium to ensure they are free from impurities and toxins. This is crucial in Siddha medicine, where the efficacy of herbal preparations greatly depends on the purity and quality of the ingredients used.
44) Discussion:
Discussion involves interpreting the study's results in relation to existing knowledge and understanding of Narkaranthai Legium and its components. It allows researchers to analyze data, draw conclusions, and suggest future research directions based on the observed safety and efficacy of the formulation.
45) Karanthai:
Karanthai refers to the botanical and medicinal properties of a specific plant used in formulations like Narkaranthai Legium. Understanding its role enhances the comprehension of traditional herbal practices, providing insight into how plant-specific benefits contribute to overall treatment outcomes.
46) Substance:
Substance pertains to the medicinal components of Narkaranthai Legium and encompasses both the active and excipient ingredients used in its formulation. A thorough understanding of each substance is essential to ascertain their individual and collective contributions to the drug’s therapeutic effects.
47) Container:
Container refers to the storage vessel used for Narkaranthai Legium post-preparation. An airtight and clean container is important to preserve the formulation's integrity and efficacy over time, preventing contamination and maintaining the pharmacological qualities of the herbal preparation.
48) Kottai:
Kottai refers to a specific herb known as Sphaeranthus indicus, included in Narkaranthai Legium. Recognized for its medicinal properties, the inclusion of Kottai demonstrates the importance of diverse botanical sources in therapeutic practices within Siddha medicine.
49) Family:
Family refers to botanical classifications grouping related plant species. The diversity of ingredients in Narkaranthai Legium signifies the complexity of herbal formulations and the traditional knowledge behind the selection of specific plants within the same family for therapeutic effects.
50) Nature:
Nature refers to the inherent qualities of the various herbs, minerals, and compounds constituting Narkaranthai Legium. Understanding the natural properties of each component aids in comprehending their synergistic effects when combined in traditional formulas for treating ailments.
51) Powder:
Powder refers to the processed form of herbs and minerals used in the preparation of Narkaranthai Legium. Proper grinding and formulation into powdered forms is critical for ensuring effective extraction of active compounds, enhancing the bioavailability of the therapeutic agents for the intended health outcomes.
52) Burning (Burn, Burned, Burnt):
Burned pertains to the method of preparing specific ingredients in the formulation, intended to enhance their medicinal properties. Controlled burning and drying processes are used in traditional practices to optimize healing qualities, ensuring the ingredients serve their intended roles in therapies.
53) Puram:
Pooram refers to a specific type of mercuric compound used in the preparation of Narkaranthai Legium. Its use is grounded in traditional Siddha medicine, reflecting how minerals and metals are incorporated into therapeutic contexts to enhance the health benefits of herbal formulations.
54) India:
India represents the cultural and geographical context from which Siddha medicine and formulations like Narkaranthai Legium originate. The rich biodiversity and traditional knowledge systems in India underscore the significance of regional practices in the global health narrative.
55) Kati:
Kaadi refers to vinegar used in the purification process of specific ingredients within Narkaranthai Legium preparation. This component plays a role in detoxifying raw materials, ensuring the resulting formulation is safe and effective when administered for therapeutic purposes.
56) Tula (Tula°):
Thula refers to a specific weight measurement used in preparing traditional formulations. Precision in dosing during the preparation of Narkaranthai Legium is essential to ensure that each component is correctly proportioned, impacting the overall efficacy and safety of the medicine.
57) Pain:
Pain refers to the bodily experience or sensation indicating potential injury or pathology. In the context of this research, assessing pain responses in laboratory rats helps evaluate the potential side effects of Narkaranthai Legium, particularly in conditions like psoriasis that involve inflammatory responses.
58) Hand:
Hand refers to the manual observation and interaction with the laboratory rats during the study. Handling the animals properly is essential for minimizing stress, ensuring their comfort, and accurately assessing their physical and behavioral responses to the administered drug.
59) Milk:
Milk often plays a role in traditional medicine preparations for its nutritional and health benefits. In Siddha practices, milk can be used in various forms to enhance the digestibility and efficacy of herbal formulations, including in the preparation of Narkaranthai Legium.
60) Salt (Salty):
Salt is a common ingredient in many culinary and medicinal preparations. In the formulation of Narkaranthai Legium, salt aids in flavor enhancement and may offer health benefits, showcasing how everyday substances are integrated into traditional healing practices.
61) Coma:
Coma refers to a state of prolonged unconsciousness, which is an important observation parameter during toxicity studies. Monitoring for signs leading to coma in the test subjects after administering Narkaranthai Legium helps assess the safety profile of the drug and its potential central nervous system effects.
Other Science Concepts:
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Siddha medicine, Herbal formulation, Safety and efficacy, Pre-clinical study, Acute toxicity study, Clinical sign, Female Wistar rats, Laboratory animals.