Steroidal and gonadotropin hormone profile studies of a classical ayurvedic preparation of “Saraguna Balijarita Makardhwaja” after chronic administration to male Sprague-Dawley rats

Farhana Kishoara; M. Jakaria Masud Munna; T. S. Farah Mousumi; Nazmun Nahar Neela; M. S. K. Choudhuri; M. Mamun Sikder

doi:10.18203/2319-2003.ijbcp20241643

Authors

Farhana Kishoara Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh
M. Jakaria Masud Munna Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh
T. S. Farah Mousumi Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh
Nazmun Nahar Neela Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh
M. S. K. Choudhuri Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh
M. Mamun Sikder Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh; Department of Biochemistry, Faculty of Medicine, Kagawa University, Kagawa 761-0793, Japan

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20241643

Keywords:

Antipyretic, Ayurvedic preparation, Gonadotropin, Hormone, Steroidal

Abstract

Background: Saraguna Balijarita Makardhwaja (SGM) is an Ayurvedic preparation used as a traditional antipyretic in the rural population. This research work was designed to get an overview of steroidal and gonadotropin hormone profiles after chronic administration of this drug.

Methods: The acute pharmacological test of SGM recorded no death or any signs of effectivity even at the highest dose of 4000 mg/kg body weight. For chronic pharmacological evaluation, sixteen healthy Sprague-Dawley male rats were randomly divided into two groups, one group was a control group and the other was an experimental group. The experimental group was assigned to receive the drug at a dose of 400 mg/kg of body weight orally. After 28 days of treatment, blood samples were collected for biochemical tests.

Results: The research showed the following effects on the steroidal and gonadotropin hormone profile. In this study, serum circulating level of dehydroepiandrosterone sulfate (DHEA-S), testosterone level, progesterone, 17-beta-estradiol (E2), luteinizing hormone (LH), and follicle-stimulating hormone (FSH) were measured to determine safety profile study of SGM after chronic administration. There were no significant differences in any parameters which is suggesting that SGM has no effect of the steroidal and hormone profile.

Conclusions: According to studies, SGM has no harmful effect on the steroid and hormone profiles after chronic treatment. Further studies are needed to establish the safety aspects of SGM.

Metrics

Metrics Loading ...

References

Chaudhary A. Gateway to global recognition of ayurveda as the system of medicine- compulsory criteria of overseas regulators must be complied by India. J Ayurveda. 2023;17:75-8.

Thakur KS, Vahalia MK, Jonnalagadda VG, Rashmi K, Nadkarni SD, Gudi RV, et al. Evaluation of structural, chemical characterization and safety studies of Samagandhak Kajjali, an Indian Traditional Ayurvedic Drug. J Pharmacog Phytochem 2014;2:57-67.

Khedekar SB, Prajapati PK. Standard manufacturing procedure of Shadguna Balijarita Makaradhwaja. Ayu. 2014;35(4):428-32.

Ali M, Sikder MM, Mondal UK, Arju LK, Biswas MK, Hasan MR, et al. Toxicological studies of an ayurvedic medicine “Swalpo Chandrodoy Makardhwaj” used as geriatric rejuvenator. Int J Pharm. 2017;7:84-9.

Sikder MM, Saha N, Neon MN, Asha UH, Sneegdha KA, Biswas MK, et al. Evaluation of pharmacological and toxicological studies of ayurvedic medicine Siddha Makardhwaja on biological system of Male Sprague-Dawley Rats. Biol Med. 2018;10:434.

Sony TA, Hasan MR, Khatun MR, Sikder MM, Hossain MM, Hasan S, et al. Toxicological studies of an ayurvedic medicine (Brihot Chandrodoy Makardhwaj) used as rejuvenator. Int J Pharm. 2015;5:759-64.

Alam MA, Jalil S, Tasnim F, Akhter N, Mukti M, Hasan RM, et al. Preclinical lipid profile studies of an ayurvedic preparation “Saraguna Balijarita Makaradhvaja” used as antipyretic. Int J Pharm. 2016;6(3):18-22.

OECD Guideline (425) for the testing of chemicals. Guidance document on acute oral toxicity. Environmental Health and Safety Monograph Series on Testing and Assessment. 2008:1-27.

Wolford ST, Schroer RA, Gohs FX, Gallo PP, Brodeck M, Falk HB, Ruhren R. Reference range data base for serum chemistry and hematology values in laboratory animals. J Toxicol Environ Health. 1986;18(2):161-88.

Bhalla A, Pannu AK. Are Ayurvedic medications store house of heavy metals? Toxicol Res. 2022;11:179-83.

Sana T, Sikder MM, Chakma P, Khalil M, Abedin N, Islam MA, et al. Toxicological studies of an Ayurvedic medicine Kankayana Gutika. Int J Pharm. 2017;7:44-50.

Sana T, Sikder MM, Abedin N, Islam MA, Barua A, Khan MA, et al. Toxicological evaluation of Guducyadi Louha, an ayurvedic formulation, on biochemical parameters of Sprague-Dawley rats. Int J Pharm. 2017;7:17-22.

Umma HA, Saha N, Sikder MM, Akter K, Sony TA, Sinha MH, et al. Preclinical HbA1c level studies of Brihat Khadir Batika and Chandraprabha Batika after chronic administration to male Sprague-Dawley rats. Int J Basic Clin Pharmacol. 2018;7:2151-5.

Neon MN, Urmy SK, Barua A, Khan MAA, Biswas MK, Choudhuri MSK, et al. Preclinical Hba1c level studies of Makardhwaj Ras and Maha Sankha Bati after chronic administration to male Sprague-Dawley rats. Trop J Nat Prod Res. 2024;8:6234-8.

Alissa EM, Ferns GA. Heavy metal poisoning and cardiovascular disease. J Toxicol. 2011;2011:870125.

Zubeldia-Brenner L, Roselli CE, Recabarren SE, Gonzalez Deniselle MC, Lara HE. Developmental and functional effects of steroid hormones on the neuroendocrine axis and spinal cord. J Neuroendocrinol. 2016;28(7):10.

Nagy B, Szekeres-Barthó J, Kovács GL, Sulyok E, Farkas B, Várnagy Á, et al. Key to life: physiological role and clinical implications of progesterone. Int J Mol Sci. 2021;22(20):11039.

Lee HR, Kim TH, Choi KC. Functions and physiological roles of two types of estrogen receptors, ERα and ERβ, identified by estrogen receptor knockout mouse. Lab Anim Res. 2012;28(2):71-6.

Pérez-López FR, Phillips N, Vieira-Baptista P, Cohen-Sacher B, Fialho SCAV, Stockdale CK. Management of postmenopausal vulvovaginal atrophy: recommendations of the International Society for the Study of Vulvovaginal Disease. Gynecol Endocrinol. 2021;37:(8):746-52.

Köhn FM. Testosterone and body functions. Aging Male. 2006;9(4):183-8.

Oduwole OO, Huhtaniemi IT, Misrahi M. The roles of luteinizing hormone, follicle-stimulating hormone and testosterone in spermatogenesis and folliculogenesis revisited. Int J Mol Sci. 2021;22(23):12735.

Louvet JP, Mitchell Harman S, Ross GT. Effects of human chorionic gonadotropin, human interstitial cell stimulating hormone and human follicle stimulating hormone on ovarian weights in estrogen-primed hypophysectomized immature female rats. Endocrinology. 1975;96(5):1179-86.

Stoléru SG, Ennaji A, Cournot A, Spira A. LH pulsatile secretion and testosterone blood levels are influenced by sexual arousal in human males. Psychoneuroendocrinology. 1993;18(3):205-18.

Hasan S, Sikder MM, Ali M, Hossain MF, Zulfiquar TN, Akter F, et al. Toxicological studies of the ayurvedic medicine “Naradiya Laksmivilasa Rasa” used in sinusitis. Biol Med. 2016;8:359.

Leeza KA, Sikder MM, Sana T, Neon MN, Bulbul L, Fardous J, et al. Toxicological Studies of an Ayurvedic Medicine Chandrangshu Ras. Int J Pharm. 2017;7:41-6.

Zulfiquar TN, Sikder MM, Sana T, Chowdhury IH, Saha N, Roy SC, et al. Organ body weight ratio toxicity studies of an ayurvedic medicine chintamanichaturmukh ras used in vertigo. Int J Pharm. 2017;7:35-40.

Akter F, Sikder MM, Hasan S, Imu IJ, Ali M, Biswas MK, et al. Evaluation of pharmacological and toxicological studies of an ayurvedic medicine Rasaraj Ras on biological system of the male Sprague-Dawley rats. Int J Basic Clin Pharmacol. 2016;5:2371-5.

Sikder MM, Hasan MR, Lopa SS, Abedin N, Uddin MJ, Sarker MMR, et al. Toxicological studies of an ayurvedic medicine “Karpur Ras” used in diarrhoea. Int J Pharm. 2015;5:472-7.

Hossain M, Hasan MR, Khalil M, Binoy MH, Sikder MM, Sony TA, et al. Toxicological studies of an ayurvedic medicine Yogendra Ras used in epilepsy. Int J Pharm. 2017;7:31–7.

Masud N, Sikder MM, Uddin MA, Roy SC, Biswas MK, Haque E, et al. Steroidal and gonadotropin hormone profile studies of a classical ayurvedic preparation of “Makardhvaja” after chronic administration to male Sprague-Dawley rats. Biol Med. 2016;9:372.

Roy SC, Sikder MM, Sarkar A, Uddin MA, Masud N, Saha N, et al. Preclinical anemia panel studies of “Makardhvaja” after chronic administration to male Sprague-Dawley rats. Biol Med. 2017;9:387.

Mondal UK, Uddin MA, Roy SC, Sana T, Sikder MM, Khalil M, et al. Preclinical lipid profile studies of a classical ayurvedic preparation Makaradhwaj Ras after chronic administration to male Sprague-Dawley rats. Int J Pharm. 2017;7:65-70.

Uddin MA, Akter F, Chowdhury IH, Asha UH, Tanny SZ, Sony TA, et al. Toxicological studies of leaf extract of Stevia rebaudiana Bertoni in Sprague-Dawley Rats. Trop J Nat Prod Res. 2022;6(5):714-20.

Saha N, Sikder MM, Uddin MA, Akter F, Asha UH, Sony T et al. Hematological studies of an ayurvedic medicine “Vata Gajendra Singha” used in rheumatoid arthritis after chronic administration to male Sprague-Dawley rats. Trop J Nat Prod Res. 2023;7:2492-7.

Sony TA, Saha N, Chowdhury IH, Tripura S, Akter S, Mumu M, et al. Preclinical blood chemistry safety profile studies of “Pijusaballi Rasa” on the kidney function after chronic administration to male Sprague-Dawley rats. Biol Med. 2020;12:466.

Sikder MM, Chakraborty P, Mahbub MR, Zulfiquar TN, Neon MN, Saha N, et al. Preclinical hematological profile studies of an ayurvedic medicine “Siddha Makardhwaja” after chronic administration to male Sprague-Dawley rats. Int J Basic Clin Pharmacol. 2018;7:93-7.

Mukinda JT, Syce JA. Acute and chronic toxicity of the aqueous extract of Artemisia afra in rodents. J Ethnopharmacol. 2007;112(1):138-44.

Alissa EM, Ferns GA. Heavy metal poisoning and cardiovascular disease. J Toxicol. 2011;2011:870125.

Mahbub MR, Sikder MM, Sony TA, Jahan NN, Faruque MO, Zaman T, et al. Effect of Pijusaballi rasa on thyroid hormones in Sprague-Dawley Rats. Biol Med. 2020;12:467.

Muneem SJS, Nasrin T, Hasan MR, Uddin MJ, Sikder MM, Bulbul L, et al. Preclinical lipid profile studies of an ayurvedic preparation Naradiya Laksmivilasa Rasa after chronic administration to male Sprague-Dawley rats. Int J Pharm. 2017;7:210-6.