Acute and 28-day toxicity study of Linga Mathirai in rats.
Journal name: World Journal of Pharmaceutical Research
Original article title: Acute and 28 day repeated oral toxicity study of siddha herbomineral formulation linga mathirai in rats
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.
This page presents a generated summary with additional references; See source (below) for actual content.
Original source:
This page is merely a summary which is automatically generated hence you should visit the source to read the original article which includes the author, publication date, notes and references.
Dr. A. Shanuvas and Dr. M. Indhumathi
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Acute and 28 day repeated oral toxicity study of siddha herbomineral formulation linga mathirai in rats
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr201811-12433
Download the PDF file of the original publication
Summary of article contents:
Introduction
The study investigates the acute and repeated 28-day oral toxicity of Linga Mathirai, a traditional herbo-mineral formulation used in Siddha medicine for treating Diabetes mellitus. Conducted in compliance with OECD guidelines, the research attempts to provide scientific validation for the safety and efficacy of this Siddha remedy, as there is a growing necessity to substantiate the safety of such formulations through rigorous evaluation.
Acute Toxicity Assessment
In the acute toxicity study, a single high dose of Linga Mathirai (2000 mg/kg body weight) was administered to Wistar albino rats, followed by observations for 14 days. The results showed no significant adverse effects including abnormal behavior, body weight changes, or mortality, suggesting that Linga Mathirai exhibits low toxicity at this dose level. Key observations recorded during the study included normal skin appearance, locomotion, and sensory responses, indicating that the formulation did not induce observable toxic effects.
Repeated Dose and Behavioral Analysis
The repeated 28-day toxicity study involved administering varying doses of Linga Mathirai (100 mg/kg, 200 mg/kg, and 400 mg/kg) once daily to groups of rats. Throughout the dosing period, all animals remained healthy with no behavioral changes or signs of toxicity observed. Weight gains were recorded over the study duration, indicating that Linga Mathirai was well-tolerated in the tested doses. The study involved careful monitoring of food consumption and checks for organ health, which provided insight into the lack of adverse effects from prolonged exposure.
Hematological and Biochemical Evaluations
Hematological and biochemical analyses were performed at the study's conclusion to further assess the safety of Linga Mathirai. The results indicated no significant alterations in key blood parameters such as red blood cell count, hemoglobin levels, and biochemical indicators, which all remained within normal ranges compared to control groups. Additionally, urine analysis yielded no abnormalities, reinforcing the conclusion that Linga Mathirai does not adversely affect renal or hematological functions in the tested doses.
Conclusion
The findings from this investigation support that Linga Mathirai can be considered safe for therapeutic usage up to 200 mg/kg body weight when administered orally. The rigorous testing under OECD guidelines demonstrated no acute or repeated toxicity, suggesting the formulation’s compatibility with traditional prescriptions in Siddha medicine. As a result, Linga Mathirai can be recommended for use in clinical settings, provided that it is administered within the established safety parameters.
FAQ section (important questions/answers):
What is Linga Mathirai and its medicinal use?
Linga Mathirai is a herbo-mineral formulation used in the Siddha system for treating Diabetes mellitus, combining plants, minerals, and traditional preparation methods.
What were the objectives of the toxicity study on Linga Mathirai?
The toxicity study aimed to evaluate the acute and sub-acute safety profile of Linga Mathirai by adhering to OECD guidelines, ensuring its safety for potential human use.
What were the findings from the acute toxicity study?
In the acute toxicity study, Linga Mathirai was administered at 2000 mg/kg, and no abnormal signs or deaths were observed in rats within 14 days.
What did the 28-day repeated toxicity study reveal?
The 28-day repeated oral toxicity study showed no significant behavioral changes or adverse effects in rats at dosages up to 200 mg/kg, indicating Linga Mathirai is non-toxic.
How were the animals cared for during the study?
The rats were housed under controlled temperature and humidity conditions, provided with proper diet, and acclimatized for a week before the experiment commenced.
What was concluded about the safety of Linga Mathirai?
The study concluded that Linga Mathirai can be safely prescribed for therapeutic use in humans at a dosage of up to 200 mg/kg without significant toxic effects.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Acute and 28-day toxicity study of Linga Mathirai in 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) Linga (Limga):
Linga refers to a specific herbo-mineral formulation used in Siddha medicine, particularly indicated for managing diabetes mellitus. This formulation is central to the study, which evaluates its safety and potential toxicity using animal models. Its significance lies in traditional medicinal practices.
2) Animal:
Animals, particularly laboratory rats, are utilized in the study to assess the safety of the Linga mathirai formulation. Their role is essential in understanding how the drug interacts biologically and ensuring accurate and applicable results for potential human usage.
3) Toxicity:
Toxicity describes the potential harmful effects of a substance, in this case, the Linga mathirai formulation. The study focuses on assessing both acute and repeated oral toxicity to ensure that the formulation can be safely used in therapeutic applications without adverse effects.
4) Study (Studying):
The study refers to the systematic research conducted to evaluate the acute and sub-acute toxic effects of the Linga mathirai formulation. It is a scientific investigation that provides evidence of safety for traditional medicine, aiming to bridge old practices with new regulatory standards.
5) Siddha:
Siddha is a traditional Indian system of medicine prevalent in Tamil Nadu, utilizing medicinal herbs, minerals, and other natural substances to treat various ailments. The relevance of Siddha in this study is to validate its age-old practices through modern scientific methods.
6) Drug:
Drug in this context refers to the Linga mathirai formulation being tested for safety and efficacy. It embodies traditional knowledge from the Siddha system and holds therapeutic promises, particularly in treating diabetes, warranting scientific investigation to confirm its safe use.
7) Table:
Table refers to the organized presentation of research data within the study. It includes numerical representations of observations, organ weights, and biochemical parameters, aiding clarity and accessibility of results, which are significant for interpreting the impact of Linga mathirai on test subjects.
8) Medicine:
Medicines encompass the various therapeutic agents used in healthcare. The study focuses on validating a specific herbal-mineral formulation, Linga mathirai, as a potential safe and effective medicine that aligns with traditional Siddha practices while meeting modern scientific standards.
9) Mineral:
Mineral indicates one of the sources used in the formulation of Linga mathirai. In the Siddha system, mineral-based medicines are valued for their potency. This study evaluates the safety of such mineral-based formulations to ensure acceptable limits for human health.
10) Observation:
Observation refers to the monitoring and recording of the animals' responses during the toxicity studies. Scientific observation is critical to determining the effects of the drug, including noting any symptoms, behavioral changes, or mortality, thus assessing the formulation's safety.
11) Chennai:
Chennai is the capital city of Tamil Nadu, India, where significant traditional and modern medical research occurs. The study's experiments were conducted in facilities located in Chennai, highlighting the region's role in advancing Siddha medicine and integrating it with modern scientific protocols.
12) Water:
Water in the context of this study is used as a solvent for preparing the Linga mathirai formulation. It serves as a vital component in drug administration and preparation, ensuring proper dosing and absorption when the compound is administered to the test animals.
13) Sign:
Sign refers to any observed indicator of toxicity or adverse effects in the animals during the study. The presence or absence of signs, such as behavioral changes or physical symptoms, helps researchers determine the safety of the administered formulation.
14) Substance:
Substance refers to Linga mathirai, the focus of the toxicity study. The investigation revolves around this particular herbo-mineral formulation, assessing its safety and potential adverse effects before considering it for therapeutic use in humans.
15) Blood:
Blood is analyzed in the study's hematological assessments to evaluate any changes in blood composition as a result of drug administration. These parameters help ensure that the Linga mathirai formulation does not adversely affect blood health, contributing to overall safety evaluations.
16) Food:
Food refers to the diet provided to the laboratory animals during the study, which is crucial for their health and the validity of experimental results. Consistent feeding supports accurate weight measurements and overall health assessments of the test subjects.
17) Science (Scientific):
Scientific pertains to the methodological and evidence-based approach taken in the study. This approach ensures that traditional knowledge, like that from the Siddha system, is validated through rigorous testing and evaluation, meeting modern standards for safety and efficacy.
18) Gingelly (Gingelli):
Gingelly oil, derived from sesame seeds, is used in the preparation of Linga mathirai. Its significance lies in both traditional medicine and as a vehicle in herbal formulations, marking its importance in the preparation process outlined in Sidda practices.
19) Pregnant:
Pregnant denotes the condition of female animals, specifically indicating that nulliparous and non-pregnant animals were used in the study to avoid variability due to hormonal influences on drug metabolism, thus ensuring the reliability of the toxicity results.
20) Kerala:
Kerala is a neighboring state to Tamil Nadu, where Siddha practices also exist. Mentioned in affiliation with one of the authors, Kerala highlights the geographical spread of traditional practices and the integration of such medicine in different regions of India.
21) House:
House, in the context of this study, refers to the laboratory animal housing for the Wistar albino rats. Proper housing is crucial to maintain controlled environmental conditions, promoting the health and welfare of the animals and ensuring reliable experimental outcomes.
22) Tamil:
Tamil refers to the language of the Siddha literature, where ancient medicinal knowledge is documented. The language's influence emphasizes the cultural and historical significance of Siddha practices and the traditional roots from which these remedies originate.
23) Cage:
Cage represents the individual enclosures used to house the laboratory animals during the study. Adequate spacing and proper cage conditions are essential for animal welfare, allowing researchers to monitor each animal's health and behavior effectively throughout the experimentation.
24) Pharmacology:
Pharmacology is the study of drug action and interactions. In this research, pharmacology plays a vital role in assessing the safety, efficacy, and mechanisms of Linga mathirai, aiming to validate traditional practices through modern scientific understanding.
25) Tamilnadu (Tamil-nadu):
Tamil Nadu, the Indian state where Siddha medicine is primarily practiced, represents the cultural and geographic foundation for the study. The state's traditional healthcare practices necessitate scientific validation, making it significant for both practitioners and researchers in the field.
26) Salivation:
Salivation is noted as one of the clinical signs monitored during the toxicity assessments. Abnormal salivation may indicate toxicity; thus, observing its presence or absence aids researchers in evaluating the safety of the Linga mathirai formulation in test subjects.
27) Activity:
Activity refers to the physiological and behavioral responses of test subjects to the administered doses. Assessing the activity level of the rats helps determine any sedative or stimulating effects of Linga mathirai, contributing to understanding its safety profile and pharmacological effects.
28) Lighting:
Lighting in the laboratory environment is carefully controlled to follow a 12-hour light/dark cycle, crucial for maintaining the circadian rhythm of the animals. This consideration is necessary to ensure consistent behavior and physiological responses during the experimental studies.
29) Relative:
Relative in this context pertains to the conditions and parameters observed in relation to the control groups. Observations of relative changes in weight, behavior, or physiological markers help interpret the impact of Linga mathirai, emphasizing its comparative effects.
30) Siddhar:
Siddhar refers to the ancient practitioners and founders of Siddha medicine, revered as scientists and spiritual leaders. Their contributions form the foundational knowledge base from which Linga mathirai and similar formulations derive, emphasizing the historical significance of traditional medicine.
31) Surface:
Surface refers to the calculated body surface area ratios used to correlate doses between rats and humans. This calculation is fundamental in pharmacology, ensuring appropriate and safe dose selection when transitioning from animal studies to potential human applications.
32) Guindy:
Guindy is a locality in Chennai associated with research facilities that contributed to the study. Its mention underscores the importance of regional institutions in fostering scientific exploration of traditional medical practices like Siddha, linking ancient wisdom with contemporary research.
33) Indian:
Indian denotes the cultural and geographical context of the study, emphasizing the roots of Siddha medicine in India. It serves as a reminder of the significance of traditional practices within the broader framework of the country's diverse healthcare system.
34) Poetry (Poetic, Poetical):
Poetry refers to the traditional form in which Siddha literature is composed. This unique style highlights the artistic aspects of medicinal knowledge, making ancient wisdom accessible while capturing the cultural essence of Siddha practices through lyrical expression.
35) Ayus (Ayush):
Ayush represents India's initiatives to promote traditional medicine, including Ayurveda, Yoga, Unani, Siddha, and Homeopathy. The involvement of AYUSH emphasizes the national recognition of Siddha practices, reinforcing the study's relevance within the broader context of integrative healthcare efforts in India.
36) Nadu:
Nadu is part of the term 'Tamil Nadu,' indicating the regional focus of the study. It underlines the connection between traditional medicine and its cultural roots, as well as the need for scientific exploration to validate established therapeutic practices within the area.
37) Silk:
Silk is mentioned in the preparation of Linga mathirai, where a silk cloth is used to cover the preparation during a specific process. This detail highlights the traditional methods employed in Siddha medicine, reflecting the cultural practices associated with the formulation's creation.
38) King:
King refers to the source of laboratory animals from the King's Institute in Guindy, Chennai. This establishes the credibility of the animal models used in the study, ensuring their health and suitability for toxicity assessments and enhancing the reliability of the research findings.
39) Diet:
Diet signifies the nutritional regimen provided to laboratory rats in the study. A controlled diet ensures that the results of the toxicity assessments are not confounded by variations in nutrition and that animals are healthy, reflecting the validity of observed outcomes.
40) Rice (Rce):
Rice is a staple food used in the traditional preparation of Linga mathirai, indicating the cultural aspects surrounding the formulation. Its inclusion highlights the connection between diet and herbal preparation in Siddha practices, maintaining tradition while potentially enhancing therapeutic effectiveness.
41) Pain:
Pain denotes one of the responses noted during the observational evaluations in the toxicity studies. Monitoring for signs of pain is critical in understanding the potential adverse effects of Linga mathirai, contributing to the overall assessment of its safety profile.
42) Male:
Male refers to the gender of half of the laboratory rats used in the study, emphasizing the inclusion of both sexes to provide comprehensive data on the formulation's effects. This approach helps ensure that research findings are applicable across gender variations.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Acute and 28-day toxicity study of Linga Mathirai in rats.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Acute toxicity, Siddha System, Hematological Parameters, Body weight change, Dose selection, Experimental protocol, Biochemical parameter, Toxicological effect, Urine parameter, OECD Guideline.