Preclinical toxicity evaluation of Habb‐e‐Azaraqi: A nux‐vomica‐based traditional Unani polyherbal formulation in rats

Abstract

ABSTRACTAimHabb‐e‐Azaraqi (HAZ) is a compound Unani formulation used clinically since decades for the management of Laqwa (facial palsy), Fālij (paralysis), Niqris (gout) and Waja'al‐Mafāsil (arthritis). The explicit nature of HAZ i.e., Muqawwi‐i‐A'sāb (nervine tonic), Muharrik‐i‐A'sāb (nervine stimulant) rationalizes its use in nervine disorders. The main ingredient of HAZ is Azaraqi/Kuchla (Strychnos nux‐vomica L.), which is considered to be toxic in nature.MethodsAcute and repeated‐dose 90‐day toxicity studies were performed as per OECD Guidelines 425 and 408, respectively. The acute toxicity study was performed at limit dose, i.e. 2000 mg/kg. The repeated‐dose toxicity study was performed at the dose levels of 100, 500 and 1000 mg/kg bw/day. Clinical signs of toxicity, body weight, and feed consumption were recorded periodically. Blood samples were subjected to hematology and clinical chemistry evaluation followed up with gross pathology and histological examinations.ResultsNo significant differences were observed in HAZ‐treated animals with respect to body weight gain, feed consumption, hematology, or clinical biochemistry as compared to control animals. There were no significant gross pathological observations between control and drug‐treated rats. A few histopathological changes were observed in the kidney of control and HAZ‐treated animals.ConclusionNo treatment‐related toxicologically significant changes were observed up to the highest tested dose except a few histopathological observations in the kidney in the high‐dose HAZ group as well as in the vehicle and satellite control groups. Data of the present study support that the traditional detoxification process effectively minimizes toxic effects of nux‐vomica used in HAZ.