A comparative clinical study to evaluate the effect of shirodhara and shirodhara with gut therapy in the management of AUTISM SPECTRUM DISORDERS in children.
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Government Ayurvedic college and Hospital kadamkuan Patna bihar india
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Reduction in the symptoms of patients in the following domains of ASD- sociability, speech and language, behavioral, sensory/cognitive.
Overview
Brief Summary
A serious issue in the modern era, autism spectrum disorders have alarmingly increased over the past few decades. Due to the socio-behavioral characteristics of the affected, ASD is one of the most puzzling forms of disability. Eye contact, facial expression, unusual gestures, diminished responsiveness, pragmatic deficits, neologism, lack of emotion in speech, unusual response to sensory stimuli, etc. are just a few examples of the severe difficulties in basic social behavior that are involved. The specific delays and deviations in social, communicative, and cognitive development seen in this subset of neuropsychiatric disorders include developmental regression, a lack of proto-declarative pointing, an abnormal response to environmental cues, abnormal social interests, a lack of symbolic play, among other things. An Indian population study that was conducted across nine different centers and five different zones came to the conclusion that the prevalence rate was 1.2%. In comparison to lower socioeconomic groups, embers of the upper socioeconomic class had a higher risk of autism. The only FDA-approved treatments for ASD are risperidone and aripiprazole, and they are only permitted for the management of irritability in ASD patients aged 5 to 16. There are currently no drugs approved to treat Core symptoms of ASD. The most empirically supported behavior modification therapies, such as applied behavior analysis (ABA), have been shown to improve language, social, play, and academic skills while also reducing the severity of behavioral problems. However, behavioral treatments are time and staff intensive, requiring up to 30 to 40 hours of treatment per week for a number of years by trained personnel working closely with the child and typically concentrating on one or a few behaviors at a time. According to Ayurveda, ASD is a behavioral abnormality with roots in a weak neuropsychological foundation and an imbalanced digestive and metabolic system. The smooth operation of Manas (mind), Buddhi (intellect), Samnja (consciousness), Jnana (knowledge), Smriti (memory), Bhakthi (desire), Seela (manners), Chesta (behavior), and Achara (conduct) is affected by a spectrum of neuropsychological disorders known as unmada. One of Manas’ key roles, knowledge acquisition (Jnanotpathy), is interfered with in Unmada. Only when Manas is in harmony with the Atma (soul), Indriya (sense organ), and Indriyartha (objects) does jnanotpathy occur. Therefore, even if their hearing is normal, they are unable to understand what is being said and act accordingly. A lack of ability to share positive emotions or grief, empathy or emotional reciprocity, etc. indicate Manas’ participation in the pathology of illness. Unmada’s clinical characteristics blend seamlessly with those of autism spectrum disorders, especially kaphaja unmada’s clinical features like- sthanam-ekdeshe and alpashchakraman (prefers sitting for longer durations, doesn’t like roaming around) tushnibhava (less talkative or interactive), lalasinghanaka-sravanam (excessive secretion of saliva and nasal mucus) etc.3 have close similarity with that of ASD’s. Imbalance of kapha dosha leads to disturbance in homeostasis of Agni which in turn affects the gut-brain axis which has a significant role in pathophysiology of ASD as affirmed by previous studies.4 Invariable correlations between the behavioral severities of ASD and dysbiosis management have been affirmed through previous studies. Sensory integration therapy also referred to as Ayres Sensory Integration (ASI), is a therapeutic approach that is used to improve symptoms of sensory integration dysfunction. Research suggests that anywhere between 90% and 95% of autistic children experience difficulties with sensory integration5. Because of this, sensory integration therapy, specifically ASI, is one of the approaches that may be considered for helping manage sensory symptoms in children with ASD. Sensory integration comprises of total 3 sensory systems which are mostly affected when someone has challenges with sensory processing. Tactile system is one of them. Shirodhara works as Samvahana (gentle massage) on the head, and this re-establishes the functions of prana Vayu and Mana, because sparshendriya (skin) is Chetsamvahi (inherently association with mind) and Vata is seated in it. Through its mechanical effect, Shirodhara reestablishes the functional integrity between the Doshas located in Shira or Hridaya as affirmed by previous studies. Thus, by acting at the level of Praanavata the shirodhara will help improve tactile system in patients of ASD. Therefore, the present research work entitled- “A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF SHIRODHARA AND SHIRODHARA WITH GUT THERAPY IN THE MANAGEMENT OF AUTISM SPECTRUM DISORDERS IN CHILDREN” is aimed at establishing the fact that whether only sensory integration or combination of it with gut therapy shows better result in patients of ASD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 3.00 Year(s) to 16.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •children satisfying the DSM V criteria and having a CARS score above 30 after screening with M-CHAT and SCQ also Diagnosed cases of ASD.
Exclusion Criteria
- •Children with intractable seizures and recurring upper respiratory infections will be excluded from the trial due to potential drug interactions and the possibility of an infection flare-up during the therapeutic phase Children having co-morbid conditions such as cerebral palsy, mental retardation and other chronic neurological and metabolic disorders will be excluded from the study.
Outcomes
Primary Outcomes
Reduction in the symptoms of patients in the following domains of ASD- sociability, speech and language, behavioral, sensory/cognitive.
Time Frame: 45days
Secondary Outcomes
- to assess the efficacy of trial medicines on disease(60 Days)
Investigators
Dr RAGHUBIR YADAV
Government ayurvedic college and hospital, Patna, Bihar-800003, India.