Non randomized controlled trial to compare the effect of Himasagara thaila as siropichu with an add on to behavioral therapy in sleep disturbances in children of Autism Spectrum Disorder among the age group 3-12yrs

Autism (or autism spectrum disorders, ASD) is a neurodevelopmental disorder characterized by deficits in social communication and the presence of restricted interests and repetitive behaviors.A diagnosis of autism spectrum disorders can be made as early as 18–24 months of age, and is well established by 3yrs of age. Autism spectrum disorder are neuro developmental conditions having a high prevalence of 1in 36 children .Sleep disturbance particularly insomnia is very common in ASD and used to be the very first symptom noticed by parents.This occurs in 50-80% in children diagnosed with ASD[3]. Sleep is critical for typical synaptic development and brain maturation, and poor sleep can have detrimental effects on children’s cognition in the domains of attention, memory, mood regulation, and behavior. Sleep disturbances accounts abnormalities of the sleep-wake rhythm, primarily sleep-onset, maintenance, and awakenings at night (with difficulty falling back to sleep), resulting in reduced sleep hours. Disturbed sleep increases ASD symptoms such as social skill deficits, communication impairments, higher rate of stereotypic behaviours and thus badly effecting the quality of life. Conventional treatments include behavioral therapy, intervention to circardian regulation such as melatonin. Although the medicines are effective, their long-term use are having side effects such as morning drowsiness, increased enuresis, headache, dizziness, hypothermia, and some studies have reported the suppression of hypothalamic pituatory axis (HPA axis) and potential for precocious puberty on discontinuation.Medicines that are sometimes used to treat behaviors related to autism include selective serotonin reuptake inhibitors (SSRIs) and antipsychotic medicines. SSRIs have side effects, such as weight gain, insomnia, and increased agitation.Hence earlier identification of sleep disturbances in ASD children could potentially prevent the development of neurobehaviour difficulties in their later life.In Ayurvedic classics psychiatric disorders are explained under the disease balaunmade (psychosis/mania).Autism spectrum disorders can also be included under this umbrella term. Hence management of balaunmade (psychosis/mania) can effectively be used in autism too.

In Ayurveda sleep disorders can be correlated to Nidranasa. Nidra, which means sleep, is described as one of the trayobasthamba [basic pillars of life].Nidra is a special state of mind in which the mind is not associated with any type of indrya[senses]. Proper sleep provides sukha [happiness], pushti [nourishment], bala [strength], vrushatha [virility], jnana [knowledge], and jivana [life].Nidranasa is defined as loss of sleep or derangement in quality of sleep.Improper sleep causes dukha [misery], karshya [emaciation], abala [weakness], ajnana [ignorance], and marana [death]. It is said that nidra is caused by tamo avarana[occultion] to Hridaya[heart].[4]Sleep disorder causes increase of autism symptoms and wise versa, autism symptoms like stereotypic movements , hyperactivity cause difficulties in sleep patterns ,both these accounts to aggravate vata and pitha.so here is a need to use safe , effective and simple formulation ,one such formulation is Himasagara thaila which is explained in Vatavyadhi Chikitsa of Bhaishajya Ratnavali [5]. It contains 37 drug, highly effective in improving sleep impairment due to increase of vata-pitha. This preparation is widely practiced in the management of sleep and clinical experiences have shown positive results.