Safety evaluation of herbal extract mixture: Ficus racemosa and Azadirachta indica.
assessment of sub-chronic toxicity in rats
Journal name: World Journal of Pharmaceutical Research
Original article title: Safety evaluation of a herbal mixture of aqueous extracts of ficus racemosa and azadirachta indica
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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Subtitle: assessment of sub-chronic toxicity in rats
Original source:
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Pearl Andrea Dias, Lathika Shetty and Suchetha Kumari Nalilu
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Safety evaluation of a herbal mixture of aqueous extracts of ficus racemosa and azadirachta indica
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
The use of herbal medicine has been practiced for centuries across various traditional systems, such as Ayurveda. Despite their widespread use, the safety of these herbal products is often questioned by modern medicine. This study focuses on the safety evaluation of a herbal mixture combining aqueous extracts of Ficus racemosa and Azadirachta indica. While each of these plants has known therapeutic effects, there is a lack of data concerning the toxicity of their combined use. Therefore, this research investigates the sub-chronic toxicity of this herbal mixture in Wistar rats under OECD guidelines.
Sub-Chronic Toxicity Assessment
The experiment involved 20 female Wistar rats divided into four groups, with three groups receiving different dosages of the herbal mixture (100, 200, and 1,000 mg/kg body weight) orally for 28 consecutive days. Observations were made regarding behavioral changes, body weight, organ weights, and hematological and biochemical parameters. The results indicated no significant toxicities based on behavioral observations. While some variations in organ weights were noted, particularly a reduction in weights of treated animals compared to the control group, overall health indicators remained within acceptable ranges.
Hematological and Biochemical Changes
Blood tests revealed notable changes in hematological and biochemical parameters, with a significant reduction in total RBC counts in the highest dosage group. However, no significant changes were observed in total WBC counts. Biochemical analysis showed a decrease in serum ALP and ALT levels across all treated groups, suggesting no detrimental impact on liver function. Furthermore, the herbal mixture appeared to lower total cholesterol and malondialdehyde (MDA) levels, indicating its potential anti-dyslipidemic properties, which aligns with its traditional use.
Behavioral and Growth Observations
During the study, animals exhibited no adverse behavioral changes, such as tremors or lethargy, and overall behavioral patterns remained normal throughout the dosing period. Some fluctuations in body weight were observed, with a significant increase in body weight for one of the groups, suggesting that the mixture may support healthy growth. The absence of serious side effects suggests that the herbal mixture can be considered safe for use in the administered dosages.
Conclusion
This study highlights that the combination of Ficus racemosa and Azadirachta indica is generally safe, with no significant evidence of toxicity based on behavioral patterns and weight analyses. However, some variations in organ weights, hematological, and biochemical parameters merit further investigation. The reduction in total cholesterol and MDA levels also hints at beneficial health effects of the herbal mixture. Existing gaps in understanding the combined effects of herbal mixtures emphasize the importance of conducting thorough safety evaluations for traditional remedies.
FAQ section (important questions/answers):
What is the focus of the study on herbal extracts?
The study evaluates the sub-chronic toxicity of a 1:1 mixture of aqueous extracts from Ficus racemosa stem bark and Azadirachta indica leaves in Wistar rats.
What were the observed effects on the rats' behavior?
No concrete evidence of toxicity was observed in the rats' behavior. They exhibited normal patterns regarding skin, fur, eyes, and mucous membranes during the study.
How did the herbal mixture affect the body weight of rats?
Group II showed a significant increase in body weight at specific intervals. Groups III and IV experienced fluctuations, with no significant overall impact on growth.
What changes were noted in organ weights of the rats?
Significant reductions in liver, kidney, and brain weights were observed in treated groups, suggesting possible effects of the herbal mixture on organ health.
What hematological changes occurred during the study?
Total RBC counts significantly decreased in Group IV, while total WBC counts remained statistically unchanged over the treatment period.
How did the herbal mixture impact biochemical parameters?
The herbal mixture showed no adverse effects on total protein or urea levels, but reduced serum ALP, ALT, total cholesterol, and malondialdehyde levels, indicating beneficial effects.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Safety evaluation of herbal extract mixture: Ficus racemosa and Azadirachta indica.”. 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) Toxicity:
Toxicity refers to the degree to which a substance can harm living organisms. In the context of herbal medicine, evaluating toxicity is crucial to determine the safety of plant extracts. The study examines sub-chronic toxicity to ensure that the herbal mixture does not pose health risks to consumers.
2) Azadirachta indica:
Azadirachta indica, commonly known as neem, is a versatile medicinal plant used in traditional medicine for treating various ailments such as jaundice, skin disorders, and infections. Its extracts are of notable interest in this study, which assesses the toxicity of a herbal mixture containing neem leaves and another plant.
3) Medicine:
Medicine represents the science and practice of diagnosing, treating, and preventing disease. Traditional herbal medicine has been utilized for centuries, often employing plant extracts. Analyzing the safety of herbal formulations is vital for integrating these practices with evidence-based medicine, which emphasizes thorough research and safety evaluations.
4) Blood:
Blood is a vital fluid that transports oxygen, nutrients, and waste products in the body. In the study, blood samples were analyzed to assess hematological and biochemical parameters. Changes in blood composition indicate the effects of the herbal mixture on physiological health and organ function during toxicity assessment.
5) Salivation:
Salivation refers to the production of saliva in the mouth. In toxicity studies, observing changes in salivation can indicate systemic effects from substances administered to the subjects. The lack of abnormal salivation during the experiment suggests that the herbal mixture may not adversely affect oral or digestive health.
6) Kumari (Kumārī, Kumāri):
Kumari is a surname indicating a female given name, possibly relating to Suchetha Kumari Nalilu, one of the authors of the study. The inclusion of personal names in research highlights contributions from individuals engaged in scientific inquiry and their research affiliations in the academic study of herbal toxicity.
7) Water:
Water is essential for life, serving as a solvent and medium for biochemical reactions. In the study, distilled water was administered to the control group and is critical for hydration of the animals. Ensuring adequate water supply during tests is fundamental to maintaining overall animal health and validity of results.
8) Ulcer:
An ulcer is a sore that develops on the skin or mucous membranes, often associated with inflammation or infection. The relevance in this study arises from traditional uses of the included herbs, promoting healing of ulcers. Understanding their efficacy and toxicity is essential for potential therapeutic applications in medicine.
9) Neem:
Neem, or Azadirachta indica, is a renowned medicinal plant with various therapeutic properties. Its extracts are commonly used for their antibacterial, anti-inflammatory, and antiviral effects. The study investigates the potential sub-chronic toxicity of neem in combination with another herbal extract, contributing to understanding its safety profile.
10) Coma:
Coma is a state of prolonged unconsciousness where a person cannot be awakened. In toxicity studies, monitoring for symptoms such as coma can reveal harmful effects of substances. The absence of coma in studied subjects suggests the herbal mixture is safe within the administered dosages, promoting further investigation.
11) Burning sensation:
A burning sensation typically indicates nerve or tissue irritation, often linked to inflammatory responses. The research's focus on behavioral observations includes assessing such sensations following herb administration. Evaluating the absence or presence of burning sensations signals the safety profile of herbal mixtures for therapeutic use.
12) Inflammation:
Inflammation is the body's response to injury or infection, often resulting in redness and swelling. The study examines the potential anti-inflammatory effects of the herbal mixture on vital organs. Understanding inflammatory responses is key to determining the pharmacological benefits and safety of traditional herbal remedies in healing.
13) Discussion:
Discussion in research refers to the section where findings are analyzed and interpreted. Here, the authors contextualize their results, comparing them to existing literature. This analysis adds depth to the study and offers insights into the implications of toxicity assessments of the herbal combination.
14) Ayurveda (Āyurveda, Ayus-veda):
Ayurveda is an ancient system of medicine from India that emphasizes natural healing using herbal remedies, diet, and lifestyle changes. This study relates to Ayurvedic practices by assessing the safety of herbal combinations traditionally used in this holistic approach, bridging ancient knowledge and modern scientific inquiry.
15) Vomiting:
Vomiting is the forceful expulsion of stomach contents, often signaling illness or toxicity. In toxicological evaluations, monitoring for signs of vomiting in study subjects helps identify harmful effects of substances. The absence of such reactions in the tested animals indicates safety of the herbal mixture at studied doses.
16) Itching:
Itching is an uncomfortable sensation typically associated with skin reactions or allergies. Observing for itching in subjects during toxicity studies helps in assessing adverse reactions to the administered substances. The study's findings on itching provide insight into the mixture's safety profile for potential therapeutic applications.
17) Kshema (Kṣema, Kṣemā):
Kshema is likely a reference to K. S. Hegde Medical Academy, the institution where the research was conducted. The academy is relevant for conducting ethical research and ensuring adherence to safety protocols during studies investigating the potency and safety of herbal medicines used in traditional healing practices.
18) Pearl:
Pearl refers to Pearl Andrea Dias, one of the authors of the study. The inclusion of authors' names highlights the contributions of various researchers involved in the investigation. Acknowledging individual authors emphasizes collaborative efforts in the scientific community to explore the safety and efficacy of herbal mixtures.
19) Drug:
A drug is a substance used for medical treatment or to alter physiological functions. In this context, the study examines herbal extracts as potential drugs derived from nature. Evaluating the toxicity of these extracts is crucial for determining their safety and effectiveness in treating various health conditions.