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CTRI Number  CTRI/2023/08/055951 [Registered on: 01/08/2023] Trial Registered Prospectively
Last Modified On: 24/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurveda Management of ADHD in children 
Scientific Title of Study   A Controlled Clinical Study To Evaluate The Efficacy Of Deepa Ghrita Over Ashtamanagala Ghrita In The Management OF ADHD (Vataja Unmada) 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 Shravani K S 
Designation  PG SCHOLAR 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurveda Medical college 
Address  Shree Jagadguru Gavisiddeshwara Ayurveda medical college Gavimata campus Dept. Of Balaroga Room No 13
Gavimata campus
Koppal
KARNATAKA
583231
India 
Phone  8722815960  
Fax    
Email  shravaniyoga11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr SURYANARAYAN M 
Designation  Associate Professor, Dept, Of Kaumarabhritya 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurveda Medical College,Koppal 
Address  Shree Jagadguru Gavisiddeshwara Ayurveda medical college Gavimata campus Dept. Of Balaroga Room No-13

Koppal
KARNATAKA
583231
India 
Phone  7411642191  
Fax    
Email  surya83.m@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr SURYANARAYAN M 
Designation  Associate Professor, Dept, Of Kaumarabhritya 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurveda medical college, Koppal 
Address  Shree Jagadguru Gavisiddeshwara Ayurveda medical college Gavimata campus Dept. Of Balaroga Room No 13

Koppal
KARNATAKA
583231
India 
Phone  7411642191  
Fax    
Email  surya83.m@gmail.com  
 
Source of Monetary or Material Support  
Shree Jagadguru Gavisiddeshwara Ayurveda Medical College and Hospital 
 
Primary Sponsor  
Name  Dr Shravani K S 
Address  Shree Jagadguru Gavisiddeshwara Ayurveda medical college Gavimata campus Koppal karnataka 
Type of Sponsor  Other [self-sponsoring] 
 
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 Shravani K S  Shree Jagadguru Gavisiddeshwara Ayurveda Medical College and Hospital  Shree Jagadguru Gavisiddeshwara Ayurveda medical college Gavimata campus Room No 13 Balaroga OPD
Koppal
KARNATAKA 		 8722815960

shravaniyoga11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Shree Jagadguru Gavisiddeshwara Ayurveda Medical College & Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F909||Attention-deficit hyperactivity disorder, unspecified type. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Deepa Ghrita, Reference: Harita Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 16(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Sukoshnajala), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Ashtamangala Ghrita, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Ghrita, Dose: 16(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Sukoshnajala), Additional Information: -
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Children those who are wishing to participate with the consent of parents will be
included.
Children diagnosed with ADHD aged between 2-16years irrespective of gender,
religion, socioeconomical status will be included for the present study. 
 
ExclusionCriteria 
Details  ADHD in children associated with other behavioural disorders like autism spectrum
disorder, intellectual disability, learning disability, seizures and other systemic
disorders will be excluded.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
assessment of inattention, hyperactivity, impulsivity  assessment done before treatment (1st day), after treatment (30th day), after follow up (60th day) 
 
Secondary Outcome  
Outcome  TimePoints 
assessment of Hyperactivity  assessed on 1st day, 30th day, 60th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/08/2023 
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="0"
Months="3"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    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 - Proposals should be directed to [shravaniyoga11@gmail.com].

  6. For how long will this data be available start date provided 01-11-2023 and end date provided 01-11-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   ADHD often co-occurs with other emotional,behavioural,language and learning disorders. Treatment includes psychosocial treatment, behavioural management, medication includes psychostimulant drugs, antidepressant drugs which are not much effective and has various side effects such as headache,anorexia,abdominal pain,seizure,sedation and depression4 ,since lack of effective treatment for ADHDparents of the children become panic and worried about their child’s future.In Ayurvedic classicsvarious treatments mentioned in the management of unmada like snehana, swedana ,mrudushodhana, bastikarma, among them snehapana is the main stay of treatment in the management of vatajaunmada6 .Hence the drug been selected in the form of ghrita,for which deepa ghrita7 has been selected to prove its clinical efficacy in the management of ADHD.Where ghritas mentioned in Ayurveda not only having ketogenic effect but also having medhya ,sangnastapana, deepana and pachana properties, hence this concept is considered to prove its efficacy in the management of ADHD.So far few researches have been done on the effect of sneha in ADHD, but deepaghrita not been proven yet. Hence the present study has been taken to evaluate the efficacy of deepaghrita in the management of ADHD and which will be compared with ashtamangalaghrita9 , which was proved to be effective in the management of ADHD. 
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