RESUMO
BACKGROUND: Autism Spectrum Disorder (ASD) refers to a collection of neurodevelopmental disorders that affect brain development and can lead to various psychological imbalances in caregivers of affected children. Siddha formulations have been shown to have a role beyond the physical body and play a significant role in managing Mantha sannior ASD. The objective of this study was to examine the impacts of Amukkara chooranam and Yegamooli thylam in the pediatric population diagnosed with ASD. METHODS: This was a prospective, interventional, non-randomized, open clinical trial involving 30 patients who met the inclusion and exclusion criteria. Patients received Amukkara chooranam at a dose of 300 mg for ages 3-4 years, 500 mg for ages 5-7 years, and 1 gm for ages 8-12 years, twice a day with honey for 90 days, and Yegamooli thylam was administered using the Thuvalai external manipulation technique once a day for 90 days. Scoring by the Indian Scale for Assessment of Autism (ISAA) was documented at the end of the 0th day, 45th day, and 90th day. RESULTS: The scores were compared at each follow-up, and a statistically significant difference was found at the end of the 90th day of treatment with Amukkara chooranam and Yegamooli thylam (P < 0.05). The statistical analysis included calculating the mean and standard deviation of the clinical assessment, parameters both before and after the treatment were 37.66667 ±13.82485. CONCLUSION: The treatment with Amukkara chooranam and Yegamooli thylam resulted in a clinically significant improvement in clinical assessment parameters in children with ASD.
RESUMO
OBJECTIVES: Madhulai Manappagu - a well-known sastric and widely prescribed Siddha herbal syrup formulation indicated for treating Veluppu Noi (Anaemia especially Iron deficiency Anaemia) has been in day today practice in Tamil Nadu for a quite longer decades. The syrup is a herbal preparation which has a sweet pleasant odour and a palatable taste, contain the juice of pomegranate (Punica granatum L.) as the main ingredient. Though the formulation is a fruit juice, the safety profile of the syrup is not established and is being marketed without toxicological evaluation. The study is aimed at ascertaining the acute and sub-acute toxicity assessment of Madhulai Manappagu in Wistar Albino rats. METHODS: The acute and sub-acute (28day repeated oral) toxicity studies were performed as per the guidelines mentioned in the Organization for Economic Cooperation and Development (OECD) 423 (adopted on December 2001) and TG 407 (adopted on October 2008) with slight modifications respectively. For acute toxicity study, three female rats were randomly selected as control; three female rats were randomly selected and were administered a single dose of 5,000 mg/kg body weight per oral route. For sub-acute (28day repeated oral) toxicity studies, three doses of test drug MM of 500 mg/kg/day (low dose), 750 mg/kg/day (intermittent dose) and 1,000 mg/kg/day (high dose) were selected for administration. Both sexes of Wistar Albino rats were randomized into four groups of 10 animals each (five males, five females). Group I was kept as control group. Group II, III and IV served as low, intermittent and high doses of MM respectively. Animals were observed for mortality, morbidity, body weight changes, feed and water intake. Haematology, clinical biochemistry, electrolytes, gross pathology, relative organ weight and histopathological examination were performed. RESULTS: In the acute toxicity study, rats showed no toxicological signs on behavior, gross pathology and body weight of rats when treated with a single dose of 5,000 mg/kg body weight per oral route. In the subacute (28 days repeated oral) toxicity study, rats have showed no significant changes on behavior, gross pathology, body weight, and hematological and biochemical parameters when treated with Madhulai Manappagu in three different doses. CONCLUSIONS: The toxicity studies which include both acute and 28 days repeated (subacute) oral toxicity studies, revealed no observed adverse effect level (NOAEL) of Madhulai Manappagu in animals. Thus the safety of the drug in human usage was ensured.