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CTRI Number  CTRI/2025/09/094139 [Registered on: 02/09/2025] Trial Registered Prospectively
Last Modified On: 02/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Effect of Ashtamangal ghrita in autism 
Scientific Title of Study   To Evaluate The Efficacy Of Ashtamangal Ghrita In Management Of Autism 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 Keerti Verma  
Designation  Head of the department  
Affiliation  Rishikul Campus Haridwar 
Address  Department of kaumarbhritya,OPD No 10, Rishikul Campus, Devpura, Haridwar, uttarakhand 249401
Department of kaumarbhritya, Rishikul Campus, Devpura, Haridwar, uttarakhand 249401
Hardwar
UTTARANCHAL
249401
India 
Phone  9997777833  
Fax    
Email  keerti.vrm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Keerti Verma  
Designation  Head of the department  
Affiliation  Rishikul Campus, Haridwar 
Address  Department of kaumarbhritya,OPD No 10, Rishikul Campus, Devpura, Haridwar, uttarakhand 249401
Kaumarbhritya vibhaag, Rishikul Campus, Devpura, Haridwar, uttarakhand 249401
Hardwar
UTTARANCHAL
249401
India 
Phone  9997777833  
Fax    
Email  keerti.vrm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Keerti Verma  
Designation  Head of the department  
Affiliation  Rishikul Campus, Haridwar 
Address  Department of kaumarbhritya,OPD No 10, Rishikul Campus, Devpura, Haridwar, uttarakhand 249401
Kaumarbhritya vibhag, Rishikul Campus, Devpura, Haridwar, Uttarakhand 249401
Hardwar
UTTARANCHAL
249401
India 
Phone  9997777833  
Fax    
Email  keerti.vrm@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus, Uttarakhand ayurveda university, Haridwar, Uttarakhand, India 249401 
 
Primary Sponsor  
Name  Rishikul Campus 
Address  Rishikul Campus, Uttarakhand Ayurved University, Haridwar, Uttarakhand, India 249401 
Type of Sponsor  Research institution and hospital 
 
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 Anubhuti Dhaaniya  Rishikul Campus  Department of kaumarbhritya,OPD No 10, Rishikul Campus, Devpura, Haridwar, uttarakhand 249401
Hardwar
UTTARANCHAL 		 7505501691

dhaaniyaanubhuti7@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 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F949||Childhood disorder of social functioning, unspecified. Ayurveda Condition: MANOVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ashtamangal ghrita, Reference: Yogratnakar Balrog chikitsaprakaran, Route: Oral, Dosage Form: Ghrita, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Go dugdh), Additional Information: -NIL
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Age between 5 to 10 years,Patients satisfying Indian Scale for Assessment of Autism (ISAA) criteria
 
 
ExclusionCriteria 
Details  Patients before 5 years and after 10 years of age, Taking ASD medicine from any other system, Presence of other organic or psychotic neurological disorders, Patients with Developmental disorders along with hearing and visual impairments, Known cases of congenital disorders, Genetic disorders like fragile X Syndrome, Turner’s Syndrome, etc.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Ashtamangal ghrita in management of autism
Subjectively all sign and symptoms are given with grading depending in their severity 		 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
o evaluate the efficacy of Ashtamangal ghrita in management of autism
Subjectively all sign & symptoms are given with gradings depending on their severity 		 Fifteen days  
 
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   N/A 
Date of First Enrollment (India)   06/10/2025 
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 Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Thesis and research articles

  6. For how long will this data be available start date provided 15-10-2026 and end date provided 15-10-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Autism is a neurological and developmental disorder that has negative impact on brain’s ability to function normally andcharacterized by qualitative impairment in verbal and non-verbal communication, in imaginative activity, and in reciprocal social interactions. Some of them, on the autism spectrum, may behave in non-typical ways, often in response to the different actions which they experience in their environment. Such behaviors are generally a way to communicate their feelings or to adapt to a situation, or may result from their heightened sensitivity to a sound or something they have seen or felt. According to Ayurveda, autism is a mental condition with a large somatic component. As a result we believe that treating psychological diseases without treating any underlying physical issues is impossible. Hence, Ayurveda treats both psychological and physical aspects of autism. The treatment include three objectives are to improve gut mucosal immunity, purify the body, and administration of Medhya medications. 

The for this trial is Ashtamangal ghrita and the study aims to evaluate the efficacy of Ashtamangal ghrita in management of autism in children. 

The duration of treatment is 105 days with assessment will be done at interval of15 days. Patients will be registered from OPD and IPD of PG department of kaumarbhritya, Rishikul Campus, UAU, Haridwar

 
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