Somina (Herbal drug) prepared by Hamdard Laboratories (Waqf) Pakistan in powdered form is widely used in Unani system of medicine for the treatment of mental illness. It is claimed that somina possesses sedative, hypnotic and anxiolytic activities [1] . Somina is composed of five different medicinal plants.

Sesamum indicum, Prunus amygdalus, Papaver somniferum, Lactuca serriola (seed extracts), Lagenaria vulgaris.

In the literature, different properties of these medicinal plants have been reported. Sesamum indicum was reported to have antioxidant [2] and anti-inflammatory activities [3] . Prunus amygdalus keeps medicinal properties such as anti-inflammatory, sedative, anti-hyperlipidemia, antitumor and antioxidant and Antimicrobial [4] . Anticonvulsant [5] and analgesic activity [6] of Papaver somniferum were cited in the literature. Lactuca serriola was found to possess spasmogenic, spasmolytic, bronchodilator, and vasorelaxant activities [7] . Since ancient times Lagenaria vulgaris has been utilized for treatment of jaundice, diabetes, ulcer, piles, colitis, hypertension and skin diseases [8] . Despite the popular use of these plants, some toxicological studies have previously performed and the results showed that at different doses Lagenaria vulgaris (2 g/kg: [9] ), Lactuca serriola (6 g/kg; [10] ), Prunus amygdalus (2 g/kg: [11] ), Sesamum indicum (500 mg/kg: [12] ) were found to be well tolerated. However, toxicity or safety of Individual constituents has reported in the literature but screening has not yet done on somina as whole to confirm its safety for the use in folkloric medicine. This study was conducted to investigate the toxicity of somina having all ingredients together.

From the experiment, the results reveal that the somina has not been found to be toxic even at 10,000 mg/kg or 10 mg/kg that is 70 times higher than the human dose in experimental animals (rats and mice) as shown in Table 3. The animals received 10,000 mg/kg orally was not found to cause any mortality and non-significant changes were observed in wellness parameters used for evaluation of toxicity. Behavioral pattern like salivation, sleep cycle and corner sitting of the treated animals were found to enhance (Table 3). However, the low doses did not produce any pronounced effect. Autopsy revealed that no changes were observed in organ structure and weight.

LD50 Value: As per observations and calculations (Karber, 1931), the LD50 value of somina after oral administration was found to be more than 10,000 mg/kg body weight.

According to Hodge and Sterner (2005) toxicity scale, somina is said to be in non-toxic herbal drug category (Table 2).

Although, the somina is used in folkloric medicine for the treatment of mental illness and research had been done to investigate its said effect [1] [17] but the present study was conducted to reveals the safety evaluation of somina, because it contain different constituent and it is a mixture of five medicinal plants. However, each plant contains different active compounds have medicinal and toxic effects. That’s why it is mandatory to evaluate the toxicity of herbal drugs (somina) whose adverse effects and toxic doses are mostly unknown [18] . Previously reported data revealed the toxic effect of different herbs at different doses such as Kava, germander (Teucriumchamaedrys). Chaparral (Larrea tridentate) causes severe liver injury [19] . Licorice can induce hypokalemic myopathy [20] and Kelp (seaweed) can cause hyperthyroidism [21] . In the present study, the somina was found to be safe up to 10,000 mg/kg orally.

This present study is in agreement with other previous studies in which different doses of constituent of somina is reported to be safe like Lagenaria vulgaris at the dose of 2 g/kg [9] , Lactuca serriola at the dose of 6 g/kg [10] , Prunus amygdalus at the dose of 2 g/kg [11] , while Sesamum indicum did not produce any toxicity up to the dose of 500 mg/kg [12] . In the present study, a maximum dose of somina was used in all above of reported literature doses were less than the present study. Although the present study confirms that somina is practically non-toxic [16] . In the present study, other organs like kidney, heart and spleen did not show any significant change.

In conclusion, the results of the present study conclude that somina is safe or practically non-toxic when administered orally. This study is the preliminary study; in the future, this research is offering an outset to continue the research by administering the somina through different routes in different animals’ species and in human.

Author is grateful to Prof. S. I Ahmed (Late) Former Dean Faculty of Pharmacy, University of Karachi, Hamdard University Karachi and Director of HMIIPHS, Hamdard University Karachi for his support, encouragement at every step of this study and Hamdard Foundation Pakistan for financial support.

Author hereby declared that the experimental protocol was approved by the University and Departmental committee for Research and Ethics. Each animal was used only once. For ethical reason, all animals were sacrificed at the end of the study (AVMA Guideline, 2013). Experimental protocol was followed according to Guidelines for Care and Use of Laboratory Animals in Biomedical Research (2010). All rules were followed as well as specific national laws where applicable.

The author has no conflict of interest to report.