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Nilakash Selkar ¹, Sharad Bhagat ¹, Mukesh Chawada ¹, Mahesh K. Vahalia ¹, Anand Puranik ¹, Geeta Vanage ¹

Affiliations
1 National Centre for Preclinical Reproductive and Genetic Toxicology National Institute for Research in Reproductive Health, Mumbai, IN

Abstract

Genetic toxicity and mutagenicity of Suvarna Bhasma (SB), an Ayurvedic drug, was determined using a battery of tests. The results of In-vivo Micronucleus assay and COMET assay did not reveal any significant increase in % Micronucleus frequency(MN) in bone marrow cells of mice and DNA damage in blood lymphocytes respectively after the oral administration of SB at various concentrations (3,-30 mg/kg bw) in treated animals as compared to vehicle control in either sex. The invitro chromosome aberration (CA) assay carried out with and without metabolic activation at different concentrations of SB in human lymphocyte culture did not cause any effect on structural or numerical chromosome aberrations. Suvarna Bhasma did not induce any mutagenic activity in presence and absence of S9 fractions in Ames assay employing three strains of salmonella typhimurium TA98, TA100 and TA102.These results demonstrated that Suvarna Bhasma preparation evaluated in this study is not genotoxic and mutagenic at the concentrations tested under the experimental conditions.

Keywords

Suvarna Bhasma, Genotoxicity, Mutagenicity, Micronucleus Assay, COMET Assay, Chromosome Aberration Assay, Ames Assay.

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Rohit Dhumal , Prakash Patil , Nilakash Selkar , Mukesh Chawda , Mahesh Vahlia , Geeta Vanage

Abstract

Objective: The present study was undertaken to determine target organ safety of “Immuforte” to establish relationship between dose or exposure and response and also to identify potential parameters for monitoring adverse effects of “Immuforte” in clinical studies, if any. Materials and Methods: A total of 40 males and 40 females were randomly assigned to the four groups, namely group I (vehicle control; gum acacia), group II (120 mg/kg BW of Immuforte in gum acacia), group III (360 mg/kg BW of Immuforte in gum acacia), and group IV (600 mg/kg BW of Immuforte in gum acacia) consisting of 10 males and 10 females in each group. Additionally, a recovery group (600 mg/kg BW of Immuforte in gum acacia) containing 5 males and 5 females was included. Results: The results showed significant decrease in percent lymphocyte count of high and mid dose groups as compared to control group. The percent neutrophil counts in all the three treated groups of male and female rats were found to be significantly higher than that of control group (P < 0.05). In females MCV values in low dose and mid dose were significantly higher as compared to control (P < 0.05). The males from low dose group showed significant decrease in total serum protein, globulin, electrolytes, direct bilirubin, creatinine levels, whereas in mid dose group along with albumin, globulin. A significant decrease in AST and cholesterol was observed. In females, significant decrease was observed in total protein and globulin of low dose and mid dose of Immuforte‑treated rats (P < 0.05). Though few hematological and biochemical parameters were different from control group, no does related response was observed and further, all these values were comparable with historical control data of the colony. Terminal body weight, organ weight, gross, and histopathology did not reveal any toxicity‑related any adverse effects. Heavy metal analysis of the blood samples collected from terminally sacrificed animals did not show presence of heavy metals viz. lead (Pb), mercury (Hg), cadmium (Cd), and arsenic (As). Conclusion: The results of the present study demonstrated that Immuforte does not cause any observable toxicity at doses used in the study when administered for the period of 90 days and is safe for the human use and thus, Immuforte could be used safely for therapeutic use in humans.

Keywords

Antioxidant, ayurveda, immunomodulation, stress, quality control

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