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CTRI Number  CTRI/2025/10/096449 [Registered on: 24/10/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of ashtamangala ghrita in autism spectrum disorder in children 
Scientific Title of Study   Clinical efficacy of Ashtamangala ghrita in Autism Spectrum disorder w.s.r to Unmad in children -An open labelled single arm clinical study 
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 Namita Jadhav 
Designation  1st year PG Scholar Kaumarbhritya  
Affiliation  Dr G D Pol Foundation YMT Ayurved college Kharghar Navi Mumbai Maharashtra  
Address  OPD NO 18 ,ground floor and Room 207 ,second floor ,department of kaumarbhritya ,Dr G D Pol Foundation YMT Ayurved college Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  8237935771  
Fax    
Email  jadhavnamita694@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhavesh Nareshchandra Panot 
Designation  Professor Kaumarbhritya department  
Affiliation  Dr G D Pol Foundation YMT Ayurved college Kharghar  
Address  OPD NO 18 ,ground floor and Room 207 ,second floor ,department of kaumarbhritya ,Dr G D Pol Foundation YMT Ayurved college Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9987076111  
Fax    
Email  bhaveshpanot@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Bhavesh Nareshchandra Panot 
Designation  Professor Kaumarbhritya department  
Affiliation  Dr G D Pol Foundation YMT Ayurved college Kharghar  
Address  OPD NO 18 ,ground floor and Room 207 ,second floor ,department of kaumarbhritya ,Dr G D Pol Foundation YMT Ayurved college Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9987076111  
Fax    
Email  bhaveshpanot@yahoo.co.in  
 
Source of Monetary or Material Support  
Dr.G.D.Pol Foundation YMT Ayurved college Kharghar Navi Mumbai Maharashtra 410210 
 
Primary Sponsor  
Name  Dr Namita Jadhav  
Address  Dr.G.D.Pol Foundation YMT Ayurved college Kharghar Navi Mumbai Maharashtra 410210 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Sandeep Rajput  Dr.G.D.Pol Foundation YMT Ayurved college Kharghar Navi Mumbai Maharashtra 410210 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Namita Jadhav  Dr G D Pol Foundation Ymt ayurved college,Kharghar,Navi mumbai  OPD NO 18 ,ground floor and Room 207 ,second floor ,department of kaumarbhritya
Raigarh
MAHARASHTRA 		 8237935771

jadhavnamita694@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee Dr G D Pol Foundation YMT Ayurvedic medical college and charitable hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F988||Other specified behavioral and emotional disorders with onset usually occurring in childhood and adolescence. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ashtamangala Ghrita, Reference: Bheshajyaratnavali Balrogadhikar, Route: Oral, Dosage Form: Ghrita, Dose: 0(ml), Frequency: bd, Bhaishajya Kal: Grasantara bhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: Dose will be calculated as per weight of child as per clarks rule.
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1.Patient diagnosed with Autism spectrum disorder according to DSM 5 criteria (Patient fulfilling all
three lakshanas from social communication domain , and two out of the 4 behavioural symptoms ) ,
irrespective of sex, religion,etc.
2 .Children aged 3 to 16 years.
3. fulfilling at least 3 out of 6 lakshanas from unmad samanya lingam criteria. 
 
ExclusionCriteria 
Details  1.Patients suffering from other complications like cerebral palsy, mental retardation, seizures, ADHD
,Rettts syndrome .
2. Severe comorbid psychiatric illness.
3. Child suffering from any Systemic illness.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in the clinical features of Autism spectrum disorder assessed by using DSM 5 ,Unmad samanya lingam and ISAA criteria for autism spectrum disorder.  1st follow up -On 30nth day of treatment
2nd follow up -On 15th day after completion of treatment  
 
Secondary Outcome  
Outcome  TimePoints 
1) To study effect of Ashtamangala ghrita, on reducing Autism spectrum disorder symptoms.
2) To compare pre- and post-intervention outcomes using standardized assessment tool to determine the
effectiveness of the Ayurvedic intervention.
3) To Observe the impact of treatment on parental satisfaction & quality of life. 		 1st follow up -On 30nth day of treatment
2nd follow up -On 15th day after completion of treatment  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 type of neurobiological disorder with key features like impairment in social communication and interaction accompanied by restricted and repetative behaviour .Autism spectrum disorder is the new name of four previously separate disorders. Autism spectrum disorder now encompasses the previous DSM – IV ,Classical autistic disorder i.e Autism , Asperger’s disorder, Childhood disintegrative disorders and Pervasive developmental disorders .In Ayurveda by examining the features of ASD it shows similarities with the symptoms of  Unmad and considering etiopathogenesis involved in ASD, there is need for medications and therapies which focus not only the higher centers of the brain, but the body with mind . Manovaha srotodushti together with Tridosha dushti is the basic cause of childhood autism spectrum disorder. Along with other etiological factors, impaired digestive and metabolic functions are postulated as the root cause of Unmad. accord with the gut brain axis, systemic accumulation of metabolic wastes also disrupts the functional integrity of the brain . Ashtamangala Ghrita is a polyherbal formulation mentioned in Bheshajyaratnavali balrogadhikar chapter ,have medhya properties and can improve memory ,intellect and cognition in children ,drugs like pippali ,sariva ,kushtha helps to maintain normal gut flora ,preventing from gut dysbiosis.The study aimed to determine effect of Ashtamangala Ghrita in reducing symptoms of Autism spectrum disorder, by using Assessment tools like DSM V , ISAA ,and Unmad Samanya lingam. 
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