Combined effect of Mahapaishachika ghritham and Balasohaladi shirolepam against Kalyanaka ghritham and Brahmisohaladi shirolepam in the socio -behavioral domains of autism in children- A randomized controlled trial

Autism is a neurodevelopmental disorder which first appears during infancy or childhood. It generally, follows a steady course without remission. Overt symptoms gradually begin after the age of six months, become established by age two or three years and tend to continue through adulthood. The prevalence of autism is 0.2% in India.  Regardless of the level of intelligence, all autistic children share basic disturbances in social interaction and communication which reduces the quality of life of both the individual and the child’s family. Thus, any treatment modality which has the capacity to treat behavioral problems, such as aggression, self-injurious behavior, and severe tantrums are helpful in improving the functioning of autistic persons at home or school. It is a challenge to the contemporary science to manage autism with its existing management protocol of Behavioral therapy. Many researches and claims in autistic research have results which are not very promising.

Mahapaishachika ghrita, Balasohaladi yogam and shirolepam are safe, effective and time-tested drugs commonly used for neuro psychiatric disorders in children. The increasing prevalence of Autism, its impact on the socio behavioral patterns in children and the lack of effective evidence based therapeutic intervention makes the study significant. It will be an open label, randomized controlled clinical trial. Children with Autism aged 3-12 years will be selected from an accessible population attending the Out Patient Department of Govt. Ayurveda College Hospital, Kannur and those satisfying the inclusion criteria will be recruited for the trial and randomly allocated into study and control groups