Oral Toxicity Studies, Histopathology and Anti-Diabetic activity of Polyherbal Extract in STZ induced diabetes in Rats

2021 ◽  
Vol 11 ◽  
Author(s):  
Pranay Wal ◽  
Nikita Saraswat ◽  
Ankita Wal ◽  
Rashmi Saxena Pal ◽  
Deepa Maurya

Background: Diabetes mellitus is a disease and endocrine disorder and it's a growing health problem in various countries. The prevalence of diabetes rises worldwide including South Africa 5.4% in 2025 increases as expected. The World Health Organization (WHO) estimated the diabetes mellitus problem in adults 173 million in developing counties. In this research observation of glucose levels indicated the diabetic state in Wistar rats by resulting from Streptozotocin administration and using a Metformin as a standard dose. This study demonstrated the acute oral toxicity and subacute oral toxicity of ethanolic extract of Saraca asoca leaves and Asparagus racemosus roots and showed the antidiabetic activity. Objective: To perform acute toxicity studies and sub-acute toxicity of the polyherbal ethanolic extract on the vital organ and isolated organ and record and noticed the visible changes on organs of each group of Wistar rats. Explore the hypoglycaemic action of the polyherbal extract of Saraca asoca and Asparagus racemosus. Methods: Wistar rats were divided into required groups for toxicity study first is acute oral toxicity 5,50, 300,2000 mg/kg body weight. Subacute oral toxicity studies were performed by administering a 250, 500, 1000mg/kg body weight. For demonstrating the antidiabetic activity the animals divided into 5 groups 1 normal control given saline group 2 standard dose Metformin compulsory dose groups 3 Streptozotocin-Induced diabetic 150mg/kg body weight body weight, groups 4 ethanolic extracts at a 100mg/kg groups 5 ethanolic extract 200mg/kg. On the last day of all the dosing period examined the Blood glucose levels and body weights of rat and histopathology studied were done by animal sacrifice and cut organs such as tissue pancreas, spleen, heart, lungs, liver, and kidney, placed on the slide and done a microscopic examination. Data selection has been complete by research papers from many databases such as NCBI, Web of science and Science direct and PubMed from year 1989 to 2020 by utilize research. skeywords such as “Antidiabetic”, “Saraca indica”, “Asparagus racemosus”, “ethanolic polyherbal extract”, “oral toxicity study”, “histopathology”, “Streptozotocin. Results : The polyherbal ethanolic extract of Saraca asoca and Asparagus racemosus at a dose of 100mg/kg and 200mg/kg was showed better effects against Streptozotocin-Induced diabetic 150mg/kg body weight body weight. All the extracts showed significantly (P <0.05) and it is safe and non-toxic nature by performed a toxicity study acute and subacute oral toxicity and the bodyweight are also improved, no inflammation and erosion are seen on any organs of Wistar rat by demonstrated a histopathology analysis. Conclusions: The polyherbal ethanolic extract of Saraca asoca and Asparagus racemosus showed hypoglycaemic activity against STZ-induced diabetes in experimental Wistar rats in Wistar rats. The results are shown beneficial effects of these ethanolic extract it helps in improving the changes in lipid metabolism, and protect the organs of Wistar rat liver, kidney, spleen, pancreas, lungs, heart against due to impairment of blood glucose and also in body weight. All organs were weighted and cut the tissue of organs and stained from eosin dye and changes observed by microscopy photos. no signs of inflammation and erosion.

2018 ◽  
Vol 8 (6-s) ◽  
pp. 44-47
Author(s):  
O. Umamaheswar Rao ◽  
M. Chinna Eswaraiah

The purpose of the study was to evaluate the single dose oral toxicity of the ethanolic extract from inflorescence of Casuarina equisetifolia, Family: Casuarinaceae in female Wistar Rats. The acute toxicity study was carried out based on Organization for Economic Co-operation and Development (OECD) Test Guideline 423. However, this plant safety evaluation data was not available so, selected the starting dose from 300 mg/kg body weight. The animals were orally administered a single dose of 300 mg/kg body weight and followed by 2000 mg/kg body weight in next step. Signs of toxicity and mortality were observed after 30 min, 1, 2, 4 and 24h of administration of the extract and once daily for 14 days. There was no mortality in the tested animals and no abnormal clinical signs were observed related to test item. No abnormalities were detected in gross pathology observations in all the rats at both the dose levels. Based on observations of the present study, it can be concluded that the LD50 of ethanolic extract from inflorescence of Casuarina equisetifolia is greater than 2000mg/kg body weight and can be classified as Category 5; however, further studies are needed to confirm long term toxicities. Keywords: Acute oral toxicity, ethanolic extract from inflorescence of Casuarina equisetifolia, LD50, OECD Test Guideline, Wistar Rat.


Author(s):  
Meenakshi Sundaram Malayappan ◽  
Gayathri Natarajan ◽  
Logamanian Mockaiyathevar ◽  
Meenakumari Ramasamy

Abstract Objectives Madhulai Manappagu – a well-known sastric and widely prescribed Siddha herbal syrup formulation indicated for treating Veluppu Noi (Anaemia especially Iron deficiency Anaemia) has been in day today practice in Tamil Nadu for a quite longer decades. The syrup is a herbal preparation which has a sweet pleasant odour and a palatable taste, contain the juice of pomegranate (Punica granatum L.) as the main ingredient. Though the formulation is a fruit juice, the safety profile of the syrup is not established and is being marketed without toxicological evaluation. The study is aimed at ascertaining the acute and sub-acute toxicity assessment of Madhulai Manappagu in Wistar Albino rats. Methods The acute and sub-acute (28day repeated oral) toxicity studies were performed as per the guidelines mentioned in the Organization for Economic Cooperation and Development (OECD) 423 (adopted on December 2001) and TG 407 (adopted on October 2008) with slight modifications respectively. For acute toxicity study, three female rats were randomly selected as control; three female rats were randomly selected and were administered a single dose of 5,000 mg/kg body weight per oral route. For sub-acute (28day repeated oral) toxicity studies, three doses of test drug MM of 500 mg/kg/day (low dose), 750 mg/kg/day (intermittent dose) and 1,000 mg/kg/day (high dose) were selected for administration. Both sexes of Wistar Albino rats were randomized into four groups of 10 animals each (five males, five females). Group I was kept as control group. Group II, III and IV served as low, intermittent and high doses of MM respectively. Animals were observed for mortality, morbidity, body weight changes, feed and water intake. Haematology, clinical biochemistry, electrolytes, gross pathology, relative organ weight and histopathological examination were performed. Results In the acute toxicity study, rats showed no toxicological signs on behavior, gross pathology and body weight of rats when treated with a single dose of 5,000 mg/kg body weight per oral route. In the subacute (28 days repeated oral) toxicity study, rats have showed no significant changes on behavior, gross pathology, body weight, and hematological and biochemical parameters when treated with Madhulai Manappagu in three different doses. Conclusions The toxicity studies which include both acute and 28 days repeated (subacute) oral toxicity studies, revealed no observed adverse effect level (NOAEL) of Madhulai Manappagu in animals. Thus the safety of the drug in human usage was ensured.


2020 ◽  
Vol 2020 ◽  
pp. 1-15
Author(s):  
Sundararaju Dodda ◽  
Venkata Krishnaraju Alluri ◽  
Trimurtulu Golakoti ◽  
Krishanu Sengupta

The present communication describes a battery of toxicity studies that include an acute oral toxicity, a subacute twenty-eight-day repeated oral dose toxicity, and genotoxicity studies on a herbal formulation CinDura® (GMCT). This proprietary herbal composition contains the extracts of the Garcinia mangostana fruit rind (GM) and the Cinnamomum tamala leaf (CT). The toxicological evaluations were performed following the Organization for Economic Cooperation and Development (OECD) guidelines. The acute oral toxicity study in Wistar rats suggests that the median lethal dose of CinDura® is at least 2000 mg/kg body weight. Acute dermal and eye irritation tests in New Zealand white rabbits indicate that the test item is nonirritant to the skin and eyes. A twenty-eight-day repeated dose oral toxicity study was conducted in male and female Wistar rats using daily doses of 250, 500, and 1000 mg/kg body weight, followed by a fourteen-day reversal period for two satellite groups. The CinDura®-supplemented animals did not show any sign of toxicity on their body weights, organ weights, and on the hematobiochemical parameters. The gross pathology and histopathological examinations indicated no treatment-related changes in the experimental animals. Overall, the no-observed-adverse-effect level (NOAEL) of the herbal blend is 1000 mg/kg body weight, the highest tested dose. Also, the results of the bacterial reverse mutation test and the erythrocyte micronucleus assay in mouse bone marrow suggest that CinDura® (GMCT) is neither mutagenic nor clastogenic.


2019 ◽  
Vol 2019 ◽  
pp. 1-12
Author(s):  
C. P. Ekanayake ◽  
M. G. Thammitiyagodage ◽  
S. Padumadasa ◽  
B. Seneviratne ◽  
C. Padumadasa ◽  
...  

Ayurvedic and traditional medical practitioners of Sri Lanka use the decoction of the immature inflorescence of Cocos nucifera L. (IC) variety aurantiaca for the treatment of menorrhagia. The progestogenic effect of the ethyl acetate soluble proanthocyanidins (EASPA) of the IC in female rats at a dose of 3.5 mg/kg body weight has been reported. Acute and subacute toxicity studies of EASPA of the IC carried out using female Wistar rats according to Organization for Economic Co-operation and Development (OECD) guidelines 423 and 407, respectively, are reported herein. In the acute toxicity study, a single dose of EASPA (2000 mg/kg body weight) was orally administered to rats, which were monitored for 14 days. In the subacute toxicity study, rats were orally administered with EASPA daily for 28 days at doses of 1.75, 3.5, 7, and 14 mg/kg body weight. No rat in either the acute or subacute toxicity study exhibited mortality or clinical signs of toxicity. Further, these rats did not show any significant change in their mean body weight, food, and water intake, haematological and biochemical parameters as well as in the results of their histopathological examinations compared to those of control group rats. According to results of the acute toxicity, the LD50 of EASPA is estimated to be greater than 2000 mg/kg body weight. Considering the results of the subacute toxicity study, the oral administration of EASPA daily for 28 days was well tolerated up to the dose, 14 mg/kg by rats. These results will be useful in the development of a novel therapeutic agent from EASPA of the IC for the treatment of menorrhagia, which incapacitates a considerable proportion of women worldwide.


2015 ◽  
Vol 7 (2) ◽  
pp. 49-54 ◽  
Author(s):  
Lovelyn Joseph ◽  
Rejeesh Edavan Puthallath ◽  
Sundarshanram Narayan Rao

Aims and Objective: To evaluate acute and chronic (90 days) oral toxicity of Valeriana wallichii rhizome hydroethanolic extract in Swiss albino mice.Materials and Methods: Valeriana wallichii rhizome was subjected to extraction with Soxhlet apparatus, using ethanol (90%) + water (10%) mixture and dried withrotavapor. Phytochemical fingerprinting of the extract was done with LC/MS (Liquid chromatography–mass spectrometry). Limit Test for acute oral toxicity at 2000 mg/kg body weight was conducted according to OECD guideline no 425. Chronic 90 day oral toxicity study with three different dose groups (200, 600, 1800 mg/kg/body weight/day) with selected in life parameters (physical, behavioural) and post mortem parameters (haematological, biochemical, gross necropsy and histopathological) as per WHO guidelines for testing safety of herbs was conducted.Results: Acute toxicity: no signs of abnormality, morbidity or mortality were observed during 14 days of observation. Chronic toxicity: Significant differences between the treated and control groups were observed in the following parameters: Loss of Auditory startle, Aggressiveness (Control > treated), Nasal discharge, Dyspnoea. At necropsy, tracheitis was observed in 3 cases. Results from Photoactometer test indicates dose dependent increase in sedative property.Conclusion: From this work it could be concluded that Valerianawallcihii rhizome hydroethanolic extract didn’t exhibit mortality, morbidity or any other neurologic, hematologic or biochemical adverse effects apart from sedation which is extension of their known pharmacological activity, after single oral dose of 2000mg/ kg bw (14 days of observation) or after once daily 200mg/kg, 600mg/kg 1800mg/kg oral treatment for 90days in healthy adult Swiss albino mice.Asian Journal of Medical Sciences Vol.7(2) 2015 49-54


2018 ◽  
Vol 2 ◽  
pp. 239784731878775 ◽  
Author(s):  
Manish Jain ◽  
Manoj Gote ◽  
Ashok Kumar Dubey ◽  
S Narayanan ◽  
H. Krishnappa ◽  
...  

Fructooligosaccharide (FOS) has been used in infant formula and conventional foods as prebiotics. Short chain FOS (FOSSENCETM) is produced by a patented process of biotransformation of sucrose by the action of enzyme from live microbial cells, hence toxicology studies were initiated to assess its safety. The objective of the present study was to determine safety of FOSSENCETM in acute, 14-day, and subchronic (90-day) toxicity studies. In acute and 14-day studies, administration of the FOSSENCETM to Wistar rats did not cause any mortality or clinical signs and changes in body weights, feed consumption, and gross pathology at the doses of 2000, 5000, and 9000 mg/kg body weight. In the subchronic (90-day) toxicity study, FOSSENCETM was administered by oral gavage to Wistar rats at the doses of 0, 2000, 5000, and 9000 mg/kg/day for 90 days. No treatment-related clinical signs or mortalities were observed. Similarly, no treatment-related toxicologically or biologically significant changes in body weight, feed consumption, ophthalmological findings, neurological effects, hematology, clinical chemistry, urinalysis, and gross pathological findings were noticed. However, statistically significant increase in weight of cecum (without correlative microscopic change) was noted at all the test item-treated groups in males and females and was considered to be a trophic effect and not a toxic effect in rats.


2016 ◽  
Vol 11 (2) ◽  
pp. 525 ◽  
Author(s):  
K.N. Sunil Kumar ◽  
R. Rajakrishnan ◽  
J. Thomas ◽  
G. Aadinaath Reddy

<p class="Abstract">Search for medicinal plants to treat liver disorders is an important research topic on herbs. Acute toxicity study is a prerequisite for safety and dose fixation for further pharmacological actions. In the present study, aqueous and 95% ethanolic extract of whole plant of <em>Helicanthus elastica</em> were subjected to acute oral toxicity. The aqueous and ethanolic extract revealed no observable changes in the rats up to the dose level of 2,000 mg /kg body weight. The extracts were then screened for paracetamol-induced hepatic injury at dose levels of 200 and 400 mg/kg body weight (1/10 and 1/5 LD<sub>50 </sub>based on toxicity study). The aqueous extract of whole plant of <em>H. elastica</em> was found to produce significant (p&lt;0.05) reversal of the paracetamol-induced changes in the measured biochemical and histopathological parameters at lower dose of 200 mg/kg which was found to be better than ethanol extract at the same dose level.</p><p class="Abstract"><strong>Video Clip:</strong></p><p class="Abstract"><a href="https://www.youtube.com/v/cO6HI1Kikxs">Acute toxicity study and others:</a> 5 min 38 sec</p><p> </p>


2012 ◽  
Vol 2012 ◽  
pp. 1-11 ◽  
Author(s):  
Chia Ju Chang ◽  
Thing-Fong Tzeng ◽  
Shorong-Shii Liou ◽  
Yuan-Shiun Chang ◽  
I-Min Liu

The objective of this study was to evaluate the acute and subacute toxicity (28 days) of the ethanol extract ofZ. zerumbetrhizomes (EEZZ) via the oral route in Wistar rats of both sexes. In the acute toxicity study, Wistar rats were administered a single dose of 15 g kg−1of body weight by gavage, and were monitored for 14 days. EEZZ did not produce any toxic signs or deaths; the 50% lethal dose must be higher than 15 g kg−1. In the subchronic toxicity study, EEZZ was administered by gavage at doses of 1000, 2000 and 3000 mg/kg daily for 4 weeks to Wistar rats. The subacute treatment with EEZZ did not alter either the body weight gain or the food and water consumption. The hematological and biochemical analysis did not show significant differences in any of the parameters examined in female or male groups. Necropsy and histopathological examination, did not reveal any remarkable and treatment related changes. A no-observed adverse-effect level for EEZZ is 3000 mg kg−1for rats under the conditions of this study. Hence, consumption of EEZZ for various medicinal purposes is safe.


Author(s):  
MANOHAR REDDY ◽  
RAJA SUNDARARAJAN

Objective: The fundamental reason for this examination was to look at the acute and subchronic toxicity studies of chloroform and methanol extracts of Barleria buxifolia Linn. (Acanthaceae) on creature models according to the OECD rules 407 and 425, respectively. Methods: In acute oral toxicity, study a single oral dosages of 5000 mg/kg body weight of chloroform and methanol extracts was given individually to rats and watched them for 2 weeks for the discovery of acute changes and for its mortality any. During acute oral toxicity study period, no mortality was seen without any signs of intense changes. Further, it was executed the subchronic toxicity of extracts. Barleria buxifolia extracts (chloroform and methanol) were independently given every day at dosages of 250 and 500 mg/kg body weight for 90 days to recognize the progressions any at subchronic poisonousness levels. Towards the finish of the experimentation the serum tests of trail creatures were gathered and watched for any progressions in haematological, biochemical and histopathological boundaries Results: All parameters of treated group were shown unaltered changes throughout the study period when compared with that of normal group. The outcomes propose that the oral organization of chloroform and methanol extracts of Barleria buxifolia did not raise any huge poisonous impacts when contrasted with that of control animals. Conclusion: Hence, the extracts may be safe for therapeutic use and as an alternative system of medicine.


2021 ◽  
Vol 2021 ◽  
pp. 1-14
Author(s):  
Sasikumar Murugan ◽  
Himanshu Solanki ◽  
Divya Purusothaman ◽  
Bharathi Bethapudi ◽  
Mital Ravalji ◽  
...  

NR-INF-02 is a standardized extract containing turmerosaccharides from Curcuma longa that has anti-inflammatory, analgesic, and chondroprotective potential. In view of its potential uses, NR-INF-02 was evaluated for its safety in Wistar rats at an oral dose of 250, 500, and 1000 mg/kg in a 90-day repeated dose subchronic toxicity study. NR-INF-02 administered at 250, 500, and 1000 mg/kg for 90 days did not show any mortality or clinical signs of toxicity. Body weight gain, food consumption, ocular and neurological examination, and hematological, blood biochemical, hormone, and urine analysis revealed no evidence of toxicity of NR-INF-02 treatment in rats. Absolute and relative organ weights were comparable to control rats. The study did not reveal any major treatment related gross pathological and histopathological alterations in the tissues or organs examined. Thus, based on study observations, the no-observed adverse effect level (NOAEL) was found to be 1000 mg/kg body weight in albino Wistar rats.


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