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CTRI Number  CTRI/2024/11/076873 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 13/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Trial to study the efficacy of Mahapaisachika Ghrita pratimarsha nasya and Tungadhrumadi Taila siropichu in children with ADHD 
Scientific Title of Study   Evaluation Of Mahapaisachika Ghrita Pratimarsha Nasya And Tungadhrumadi Taila Siropichu In The Management Of Adhd In Children – A Randomised 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 Brihathi Bala V J 
Designation  PG Scholar 
Affiliation  KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  Department of Kaumarabhritya KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  08300193030  
Fax    
Email  vjbrihathi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Azizahmed I Arbar 
Designation  Professor and HOD 
Affiliation  KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  Department of Kaumarabhritya KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9844532113  
Fax    
Email  azizarbar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Azizahmed I Arbar 
Designation  Professor and HOD 
Affiliation  KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya 
Address  Department of Kaumarabhritya KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9844532113  
Fax    
Email  azizarbar@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 
 
Primary Sponsor  
Name  KLE Shri B M Kankanawadi Ayurveda Hospital 
Address  KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka 
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 Azizahmed I Arbar  KLE Shri B M Kankanawadi Ayurveda Hospital  OPD no 10 Department of Kaumarabhritya KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya
Belgaum
KARNATAKA 		 9844532113

azizarbar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research on Human Subjects KAHERs Shri B M Kankanawadi Ayurveda Mahavudyalaya and KLE Ayurveda Hospital Shahapur Belagavi  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
1Comparator ArmDrugClassical(1) Medicine Name: Brahmi ghrita, Reference: Ashtanga Hridaya Uttarasthana 6/23, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: -
2Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: Ashtanga Hridaya sutrasthana, Procedure details: The prescribed drops of medication is instilled in one nostril while the other one is closed & the procedure is repeated for the other nostril. followed by Siropichu with Tungadhrumadi taila duration 7 days dose 15 ml reference sahasrayoga taila prakara 44)
(1) Medicine Name: Mahapaisachika Ghrita, Reference: Caraka samhita cikitsa sthana 9 , Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Duration: 30 Days
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Children of either sex between the age group of 4-16 years
Children fulfilling the DSM V diagnostic criteria for diagnosis of ADHD 
 
ExclusionCriteria 
Details  Children with any known acute or chronic, local or systemic infection
Children with any known nose related pathology contraindicated for nasya
Known case of cerebral palsy, mental retardation, epilepsy and hearing defect etc.
Children with congenital anomalies like cleft palate, CHD etc.
Children who have received any form of intervention for ADHD in the last 3
months. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
There might be significant effect of Mahapaishachika ghrita pratimarsha nasya and
Tungadhrumadi taila siropichu in the management of ADHD in children
Measured by changes in the Vanderbilt ADHD assessment criteria 		 0 day
7 days
15 days
30 days 
 
Secondary Outcome  
Outcome  TimePoints 
There might be significant effect of Mahapaishachika ghrita pratimarsha nasya and
Tungadhrumadi taila siropichu in the management of ADHD in children
Measured by changes in the PedsQL questionnaire 		 0 day
7 days
15 days
30 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)   01/01/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Attention Deficit Hyperactivity Disorder is one of the most common neurobiological disorders in children and adolescents. It has a negative impact on the children’s as well as the parents’ social lives and more often than not becomes a financial burden. The children in question end up with weak social relationships and low self-esteem and poor academic performance leading to an overall poor quality of life. The global prevalence of ADHD has risen to 7.6% of 96,907 children aged 3 to 12 years and 5.6% of teenagers aged 12 to 18 according to a study done in April 2023. The prevalence of ADHD in the city of Belagavi was studied to be 5.76% among children between 6 to 11 years of age. Isolated or combination of available pharmacotherapy is used with methylphenidate and dextroamphetamine, both of which are psychostimulants, as the mainstay treatment. One third of the patients who are being treated with psychostimulants report significant adverse results such as anorexia, abdominal pain, weight loss, depressed mood, sleep disturbances and lack of appetite. Concerns about long term effects and drug safety have led more than 50% of parents of ADHD children to seek Alternative/Complementary medicine. According to a meta-analysis, Ayurveda interventions have their benefits in reducing symptoms of ADHD. This Study is undertaken for the management of ADHD by the use of formulations expounded in Ayurveda treatises. ADHD is comparable to Unmada which is described as a disorder of the manovaha srotas. Ghrita is mentioned as a remedy for Unmada in Caraka Samhita Sutrasthana Annapanvidhi Adhyaya. It enhances cognitive abilities. Mahapaisachika ghrita, Tungadhrumadi taila and several other medicines are neuroprotective and cognitive enhancers which help in reducing the symptoms of ADHD.
 
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