Subscribe

Subscribe to our Newsletter and get informed about new publication regulary and special discounts for subscribers!

IJPPE > IJPPE Volume 15 > 90-Days Repeated Dose Oral Toxicity Study on...
< Back to Volume

90-Days Repeated Dose Oral Toxicity Study on Majoon-e-Nisyan

Full Text PDF

Abstract:

Majoon-e-Nisyan (MJN) is a polyherbal semisolid compound formulation. Its description is present in various Unani literatures. It is used in Unani medicine for its therapeutic efficacy against amnesia. There is no report regarding its safety on long term administration. Therefore, toxicological evaluation of MJN is carried out in rats. Majoon-e-Nisyan was subjected to 90-days repeated oral dose toxicity studies as per OECD guide line 408. Wistar rats were treated at three dose levels i.e., 500, 1000 and 2000 mg/kg bw and one vehicle treated group. MJN and vehicle were orally administered daily for 90 days and animal were observed for clinical signs of toxicity, mortality, body weight and feed consumption. On completion of 90-days, blood samples were collected and analyzed for hematology and biochemistry. Necropsy was performed on all survived animals and vital organs were collected and subjected to histopathology. No post dose adverse effect was reported on survival of both male and female rats after oral administration of MJN for 90 days. No incidence of mortality was reported in MJN treated male and female rats at all tested dose levels. No abnormal clinical signs were observed in MNJ treated animals at 500, 1000 and 2000 mg/kg bw as compared to animals of control group. No significant changes were observed in biochemistry, hematology and histopathological examination. No incidence of mortality, adverse changes in clinical signs of toxicity or body weight gain of rats was noted. No changes in clinical chemistry, hematology, and histopathology were observed in MJN-treated or control group. Therefore, NOAEL for MJN may be considered more than 2000 mg/kg bw in rats. Subject Classification Numbers: Pharmacology, Toxicology.

Info:

Periodical:
International Journal of Pharmacology, Phytochemistry and Ethnomedicine (Volume 15)
Pages:
22-33
Citation:
M. Shaikh et al., "90-Days Repeated Dose Oral Toxicity Study on Majoon-e-Nisyan", International Journal of Pharmacology, Phytochemistry and Ethnomedicine, Vol. 15, pp. 22-33, 2020
Online since:
June 2020
Export:
Distribution:
References:

[1] Consumer Reports; Drug effectiveness Review Project (May 2012). Evaluating Prescription Drugs Used to treat, Alzheimer's disease Comparing Effectiveness, Safety, and Price. Consumer Reports: 2. Retrieved 1 May 2013.,.

[2] Anonymous, Standard Unani Medical Terminology, CCRUM, Dept. of AYUSH, New Delhi, April 2012; p.184.

[3] Ahmad KR. Tarjuma Sharah Asbab, CCRUM, Dept. of AYUSH, New Delhi 2010; Vol-I, pp.172-85.

[4] Fatima S. et.al., Preventive, Promotive and Curative Aspects of Dementia in complementary medicine(Unani): Through-Black Box-Design, Int. J. of Herbal Medicine, 2017; 5(10):1-5.

[5] Anonymous, Qarabadeen-e-Majeedi, Hamdard Publication, 9th ed.1986; pp.397-98.

[6] HM, Kabeeruddin. Al-Qarabadeen, CCRUM, Ministry of AYUSH, New Delhi, 2006; p.1134.

[7] Anonymous, Unani Pharmacopoeia of India, Dept. of AYUSH, Ministry of Health and Family Welfare, Govt. of India.,2010; part 2nd, Vol-II; pp.113-115.

[8] CPCSEA, Compendium of CPCSEA (2018). New Delhi: Committee for the Purpose of Control and Supervision of Experiments on Animals, Animal Welfare Division, Ministry of Environment, Forest & Climate Change, Government of India, (2018).

[9] Anonymous, Unani Pharmacopoeia of India, Dept. of AYUSH, Ministry of Health and Family Welfare, Govt. of India.,2010; part 2nd, Vol-II; pp.113-115.

[10] Reagan-Shaw, Nihal M, Ahmad N. Dose translation from animal to human studies revisited, FASEB J. 2008;22(3): pp.659-61.

DOI: https://doi.org/10.1096/fj.07-9574lsf

[11] OECD guideline 408, Repeated Dose 90-day Oral Toxicity Study in Rodents, (1998).

DOI: https://doi.org/10.1787/9789264304741-23-en

[12] Gotmi Sharwan, Parag Jain, Ravindra Pandey, S.S.S. Toxicity profile of traditional herbal medicine. J. Ayu. Herb. Med. 2015;1, 81–90.

[13] Ifeoma, O., Oluwakanyinsol, S. Screening of Herbal Medicines for Potential Toxicities, New Insights into Toxicity and Drug Testing, Sivakumar Gowder, IntechOpen. 2013;.

DOI: https://doi.org/10.5772/54493

[14] Testa NG and Dexter TM. Long-term hematopoietic damage: concepts, approaches, and results relevant to the study of environmental toxins. Environ mental Health Perspective 1989 Jul; 82: 51–56.

DOI: https://doi.org/10.1289/ehp.898251

[15] Lawal, B., Shittu, O.K., Oibiokpa, F.I., Mohammed, H., Umar, S.I., Haruna, G.M. Antimicrobial evaluation, acute and sub-acute toxicity studies of Allium sativum. J. Acute Dis. 2016; 5, 296–301.

DOI: https://doi.org/10.1016/j.joad.2016.05.002

[16] Saidu Y., Bilbis, L.S., Lawal, M., Isezuo S.A., Hassan, S.W., Abbas, A.Y. Acute and Sub-chronic Toxicity Studies of Crude Aqueous Extract of Albizzia chevalieri Harms (Leguminosae). Asian J. Biochem. 2007; 2, 224–236.

DOI: https://doi.org/10.3923/ajb.2007.224.236

[17] Devarbhavi H. An Update on Drug-induced Liver Injury. Journal of Clinical and Experimental Hepatology. 2012; 2(3): 247-259.

[18] EMEA. Non-Clinical Guideline on Drug-Induced Hepatotoxicity. London, E14 4HB, UK: European Medicines Agency.2008; pp.1-16.

[19] Singh A BT, Sharma OP. Clinical Biochemistry of Hepatotoxicity. Journal of Clinical Toxicology. 2011;S4:001.

[20] Ramaswamy RS, Prathyusha N, Saranya R, Sumathy H, Mohanavalli KT, Priya RJ, et al. Acute toxicity and the 28-day repeated dose study of a Siddha medicine Nuna Kadugu in rats. BMC Complementary and Alternative Medicine 2012;12: 190.

DOI: https://doi.org/10.1186/1472-6882-12-190

[21] Fuchs TC, Hewitt P. Biomarkers for drug-induced renal damage and nephrotoxicity-an overview for applied toxicology. The AAPS Journal. 2011; 13(4): 615-631.

DOI: https://doi.org/10.1208/s12248-011-9301-x

[22] Vincent Castagne CF-Ca, Elise Esneault, Hernier Anne Marie, Martine Lemaire, and Roger D. Porsolt. Rotarod Test. In: H. Gerhard Vogel JM, Franz J. Hock, Dieter Mayer (eds). Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays, Second edn. Heidelberg Dordrecht London New York: Springer-Verlag. 2013; pp.29-30.

DOI: https://doi.org/10.1007/978-3-642-25240-2_3

[23] Deacon RM. Measuring motor coordination in mice. Journal of Visualized Experiments : JoVE(75): e2609.(2013).

DOI: https://doi.org/10.3791/2609

[24] Vogel HG (ed). Drug Discovery and Evaluation: Pharmacological Assays. Springer-Verlag: Germany. (2008).

[25] Sellers RS, Morton D, Michael B, Roome N, Johnson JK, Yano BL, et al. Society of Toxicologic Pathology position paper: organ weight recommendations for toxicology studies. Toxicol Pathol. 2007;35:751–5.

DOI: https://doi.org/10.1080/01926230701595300
Show More Hide
Cited By:
This article has no citations.