CTRI/2025/02/080105 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On:
06/02/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical study to see whether shirodhara alone or shirodhara with gut therapy that is rajanyadi choorna and agnikumar rasa is more effective in patients of Autism Spectrum Disorders in children.
Scientific Title of Study
A comparative clinical study to evaluate the effect of shirodhara and
shirodhara with gut therapy in the management of AUTISM SPECTRUM
DISORDERS in children.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr RAGHUBIR YADAV
Designation
PG SCHOLAR
Affiliation
Government ayurvedic college and hospital, Patna, Bihar-800003, India.
Address
Department of Kaumarbhritya,2nd floor, Government Ayurvedic college and Hospital,kadamkuan, Patna.
Patna BIHAR 800003 India
Phone
09560355313
Fax
Email
raghuveeryadav87@gmail.com
Details of Contact Person Scientific Query
Name
Dr Arvind chaurasia
Designation
professer and Head of department, Department of kaumarbhritya.
Affiliation
Department of Kaumarbhritya, Government ayurvedic college and hospital, Kadamkuan, Patna.
Address
Department of Kaumarbhritya,2nd floor, Government Ayurvedic college and Hospital,kadamkuan, Patna.
Patna BIHAR 800003 India
Phone
9835255180
Fax
Email
arvindschaurasia@gmail.com
Details of Contact Person Public Query
Name
Dr Arvind chaurasia
Designation
professer and Head of department, Department of kaumarbhritya.
Affiliation
Department of Kaumarbhritya, Government ayurvedic college and hospital, Kadamkuan, Patna.
Address
Department of Kaumarbhritya,2nd floor, Government Ayurvedic college and Hospital,kadamkuan, Patna.
Patna BIHAR 800003 India
Phone
9835255180
Fax
Email
arvindschaurasia@gmail.com
Source of Monetary or Material Support
Goverment ayurvedic college and hospital,Kadamkuan, Patna, Bihar- 800003, India.
Primary Sponsor
Name
Government Ayurvedic college and Hospital kadamkuan Patna bihar india
Address
Government Ayurvedic college and Hospital,kadamkuan, Patna, bihar- 800003, India.
Type of Sponsor
Government medical college
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr RAGHUBIR YADAV
Government ayurvedic college and hospital, Patna.
government ayurvedic college and hospital, Kadamkuan, Near budhh Murti, patna, bihar- 800003, India. Patna BIHAR
09560355313
raghuveeryadav87@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethical Committee
Approved
Regulatory Clearance Status from DCGI
Status
Awaited
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:F54||Psychological and behavioral factors associated with disorders or diseases classified elsewhere. Ayurveda Condition: UNMADAH,
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Intervention Arm
Drug
Classical
(1) Medicine Name: agnikumar rasa, Reference: sahasra yogam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: (2) Medicine Name: , Reference: rajanyadi choorna , Route: Govind das Sen. Bhaishajya Ratnavali. English commentary, Varanasi, Chowkhamba Sanskrit series office; Jwaradhikarah. pg. no. 287., Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 9(3), Frequency: g, Bhaishajya Kal: bd, Duration: Adhobhakta, anupAna/sahapAna: No, Additional Information: luke warm water
2
Comparator Arm
Procedure
-
Shirodhara
(Procedure Reference: Vagbhata. Ashtanga Hridayam. Vidyotini Hindi commentary Sutrasthana, 22/23 Chaukhamba Prakashana, Varanasi, Edition; Reprint, 2009, page no.182., Procedure details: once a day for 30 minutes) (1) Medicine Name: Brahmi taila, Reference: Ayurveda Sara Samgraha. Nagpur Maharashtra. Baidyanath Ayurved Bhavan. , Route: Topical, Dosage Form: Taila, Dose: 2000(ml), Frequency: od, Duration: 30 Days
Inclusion Criteria
Age From
3.00 Year(s)
Age To
16.00 Year(s)
Gender
Both
Details
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
ExclusionCriteria
Details
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
Method of Generating Random Sequence
Adaptive randomization, such as minimization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Reduction in the symptoms of patients in the following domains of ASD- sociability, speech and language, behavioral, sensory/cognitive.
45days
Secondary Outcome
Outcome
TimePoints
to assess the efficacy of trial medicines on disease
60 Days
Target Sample Size
Total Sample Size="40" Sample Size from India="40" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Phase of Trial
Phase 2
Date of First Enrollment (India)
25/02/2025
Date of Study Completion (India)
Date Missing
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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.