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CTRI Number  CTRI/2024/08/071895 [Registered on: 05/08/2024] Trial Registered Prospectively
Last Modified On: 03/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Role of Saraswata Churna with Panchbhautika taila nasya in the management of Autism in children 
Scientific Title of Study   Evaluation of Saraswata churna with Panchbhautika taila nasya in the management of autism in children- a randomized controlled clinical trial 
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 Suman Devenda 
Designation  MD Scholar 
Affiliation  National institute of ayurveda, jaipur 
Address  PG Department of Kaumarbhritya National Institute of Ayurveda jaipur - 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9351593040  
Fax    
Email  sumdevanda108@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Nisha Kumari Ojha 
Designation  MD, Ph.D. (AY.) PDCR, B.Sc., Dean(Ph.D) HOD Dept of Kaumarbhritya 
Affiliation  National institute of ayurveda, jaipur 
Address  PG Department of Kaumarbhritya National Institute of Ayurveda jaipur - 302002

Jaipur
RAJASTHAN
302002
India 
Phone  8890072697  
Fax    
Email  drnishaojha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Nisha Kumari Ojha 
Designation  MD, Ph.D. (AY.) PDCR, B.Sc., Dean(Ph.D) HOD Dept of Kaumarbhritya 
Affiliation  National institute of ayurveda, jaipur 
Address  PG Department of Kaumarbhritya National Institute of Ayurveda jaipur - 302002

Jaipur
RAJASTHAN
302002
India 
Phone  8890072697  
Fax    
Email  drnishaojha@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Jaipur - 302002 Rajasthan India  
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
Address  National Institute of Ayurveda, jaipur - 302002 Rajasthan 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 Suman Devenda  Hospital National Institute of Ayurveda, Jaipur  OPD No. 5 dept of Kaumarbhritya National Institute of Ayurveda, Jaipur Rajasthan
Jaipur
RAJASTHAN 
9351593040

sumdevanda108@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: kashyap samhita kalpasthan , Procedure details: Pratimarsah nasyam 2 drops in each nostril at morning )
(1) Medicine Name: Panchbhautika taila, Reference: kashyap samhita,kalpasthan, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 3 Months
2Intervention ArmDrugClassical(1) Medicine Name: Saraswata Churna , Reference: Bhaishjya Ratnavali Unmada Rogadhikara Adhyaya 19(26-29), Route: Oral, Dosage Form: Churna/ Powder, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -madhu and ghrita), Additional Information: -
3Comparator Arm (Non Ayurveda)-Roasted Wheat Flourdose-375-600 mg with madhu and ghrita sevan kala pragbhakta for 3 months
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Age between 03 to 09 years.
2. Diagnosed cases of Autism satisfying DSM 5/ AIIMS Modified INCLEN criteria (INDT- ASD) of either sex
3. Patients with score above 70 in Indian Scale for assessment of Autism (ISAA).

 
 
ExclusionCriteria 
Details  1. ASD medications from any other system
2. Mental retardation, Cerebral palsy
3. Presence of other organic or psychotic neurological disorder
4. Pervasive developmental disorder
5. Hearing and visual impairment
6. Patients with acute and chronic systemic illness such as renal diseases, Hepatic dysfunction, Juvenile diabetes mellitus etc
7. Congenial disorders, Genetic syndromes like Fragile X syndrome, Turner syndrome etc
8. Progressive and non-progressive neuromuscular disorders
9. Endocrinal disorders, Protein Energy Malnutrition (PEM), Inborn error of metabolism
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Change in ISAA score  baseline, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.-Change in DSM V criteria  baseline, 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/09/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Autism is a complex neuro-developmental disorder that tremendously affects the normal functioning of brain which challenges the child’s development. Autism is characterized by impaired communication (both verbal and nonverbal), impaired interpersonal social interaction and repetitive, restricted and stereotype mannerism of behavior or presence of unusually strong narrow interest. The presentation of these impairments is variable in range and severity and varies with the acquisition of other developmental skills.

According to WHO report, it is estimated that worldwide about 1 in 100 children have autismi. In India according to a report by ET Health World, about 18 million people in India are diagnosed with autism. About 1 to 1.5 percent of children aged 2 to 9 years are diagnosed with ASDii. Autism affects more male than female individuals. Etiology of autism is not yet known, but both genetic and environmental factors appear to play role. Environmental factors that may contribute to the etiology of ASD include pre or postnatal exposure to certain environmental chemicals and drugs, stress, maternal infection and dietary factors. Along with this, alteration in gut microbiota (gut dysbiosis) and other GI disorders are found in autistic children. That is derangement in digestive and metabolic system. Autism has close similarities to the features of that Unmada which is described in Ayurveda. The condition due to Dushta Dosha caused by the Mithyahara or Vihara consumption by an Alpa Satva person, which gets lodged in the Sthana of Buddhi, that is Hridaya and later does Margavarana of Manovaha Srotas leading to different lakshanas (manifestations). Looking to the manifestations of Unmada, some of them can be seen in autism spectrum disorders. These include involve impairments of -

Manas vibhramam – total or partial loss of sensory perception.

Buddhi vibhramam - intellect-partially affected –could be irregular as shown in savant skill.

Samjanajana vibhramam- impaired consciousness.

Smriti vibhramam –impaired memory.

Bhakti vibhramam- impaired desire, loss of innate quality of self-realization.

Seela vibhramam- socially inappropriate outbursts and adherence to strict rigid routines.

Chesta vibhramam- activities motor stereotype that are improper and compulsive.

Achara vibhramam- poor socialization skills, failure to obey orders, loss of healthy habits.

 
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