What question did this study set out to answer?

To evaluate the acute and repeated-dose oral toxicity of three Unani herbal formulations in rats.

April 30, 2026Hippocratic Journal of Unani Medicine0 citationsOpen Access

Acute and Subacute Oral Toxicity Studies of Classical Polyherbal Unani Formulation Sharbat-e-Ejaz, Sharbat-e-Unnab, and Itrifal-e-Shahtara in Rats: Evidence of a Favorable Safety Profile

EVEnumula Vinay MUMohd Urooj DDDurgesh Kumar DwivediRegional Research Institute of Unani Medicine

Key Points

To evaluate the acute and repeated-dose oral toxicity of three Unani herbal formulations in rats.
Administered SEJ and SUN at doses of 2, 4, and 10 mL/kg BW, and ITS at 500, 1000, and 1500 mg/kg BW.
Followed OECD 425 and OECD 407 guidelines for toxicity assessment.
Conducted histopathological and biochemical evaluations post-administration.
No mortality or significant clinical signs were observed during the study.
Minor alterations in hematological and biochemical parameters remained within normal limits.
Histological changes in lungs and livers were mild-to-moderate, observed in both control and treatment groups.

Abstract

Abstract Background: Sharbat-e-Ejaz (SEJ) and Sharbat-e-Unnab (SUN) are traditional polyherbal Unani formulations widely used for respiratory ailments. Whereas, Itrifal-e-Shahtara (ITS) is indicated for the management of putrefaction of blood, syphilis, cephalgia, and pruritus. Despite their therapeutic popularity, comprehensive toxicological evaluations remain limited. Objective: This study aimed to evaluate the acute and repeated-dose 28-day oral toxicity of SEJ, SUN, and ITS in rats to establish preclinical safety profiles. Materials and Methods: Rats were administered SEJ and SUN at doses of 2, 4, and 10 mL/kg body weight (BW), and ITS at 500, 1000, and 1500 mg/kg BW. Acute and repeated-dose 28-day toxicity was assessed following OECD 425 and OECD 407 guidelines, respectively. Results: No mortality, treatment-related clinical signs, no significant changes were observed in hematological and biochemical parameters across all dose levels of SEJ, SUN, and ITS, except for minor, statistically significant alterations, including isolated changes in mean corpuscular hemoglobin, aspartate aminotransferase, blood urea, and triglycerides, which remained within normal physiological limits and were considered toxicologically insignificant. Further, no significant histological alterations were observed across all dose levels of SEJ, SUN, and ITS, except mild-to-moderate histological changes were observed in the lungs and livers. These histological changes were also present in control animals, suggesting nontreatment-related background lesions. Conclusion: All three SEJ, SUN, and ITS exhibited a high margin of safety with the absence of systemic toxicity, even at doses 4–10-fold higher than the therapeutic dose in the acute study and 3–5-fold higher in the subacute study. Present findings support the safe use of studied Unani formulations i.e., SEJ, SUN and ITS at therapeutically recommended doses, justifying respective clinical application under evidence-based practice.

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