BackgroundJawarish Jalinoos (JJ) is a classical semisolid traditional Unani formulation clinically used for the treatment of weakness of vital organs, liver, and stomach. Although JJ has been widely used clinically for several decades, no scientific report is available for its safety.MethodsJJ and its sugar-free tablet version (SFJJ; formulated to target diabetic population) were assessed for safety in rats. Ninety-day repeated dose oral toxicity study was performed as per the Organisation for Economic Co-operation and Development Guideline 408. JJ was orally administered at the dose of 2000 mg/kg bw/d, whereas SFJJ was orally administered at the doses of 506 mg/kg body weight (bw)/d, 1012 mg/kg bw/d, and 2024 mg/kg bw/d for 90 days. The animals were periodically observed for clinical signs of toxicity, mortality, morbidity, body weight changes, and feed consumption. At the end of the study, hematology, clinical biochemistry, electrolytes, gross pathology, relative organ weight, and histological examination were performed.ResultsTreatment with SFJJ and JJ showed no significant differences in body weight gain, feed consumption, hematology, clinical biochemistry, and serum electrolytes. No gross pathological findings and differences in relative organ weights were observed between control and drug treated rats. Histological examination revealed no toxicologically significant abnormalities related with SFJJ or JJ treatment.ConclusionThe 90-day repeated dose oral toxicity study demonstrates that the no observed adverse effect level of SFJJ and JJ is greater than 2024 mg/kg bw/d and 2000 mg/kg bw/d (p.o.) in rats, respectively. Both formulations were found to be safe up to the tested dose levels and experimental conditions, and therefore safe for clinical use as specified in the literature.
India has a variety emporium of the medicinal and aromatic plants (MAPs) andhas well established local healthcare tradition still relevant in indigenous health care system; Unani Medical System is one of them. Unani System of Medicine based on Hippocratic theory of humours is well established in India. Simultaneously it is also believed that Unani dosage forms acts on human body in holistic way and do not exhibit the adverse effects. It is true up to some extent but not at all. Unani dosages forms are sometime exhibit adverse effects if not consumed in proper quantity or prepared in proper manner. Habb-e-Shia is a pharmacopoeial preparation and used as Daf-e-Humma (Antipyretic), Daf-e-Tashannuj (Anti-Spasmodic), Musakkin-e-Alam (Analgesic) agent in Unani System of Medicine. Habb-e-Shifa has shown some adverse reaction to a female patient suffering with Suda-e-Muzmin (Chronic headache due to rhino-sinusitis).
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