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CTRI Number  CTRI/2025/10/096580 [Registered on: 29/10/2025] Trial Registered Prospectively
Last Modified On: 28/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Role of mahapaishachika ghrita in neurobehavioral disorder. 
Scientific Title of Study   Efficacy of Mahapaishachika Ghrita in management of Attention deficit hyperactivity disorder[ADHD]w.s.r.To Unmad -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 Vaibhavi Ashok Dange 
Designation  1st year PG Scholar Kaumarbhritya  
Affiliation  DR G D POL Foundation YMT Ayurvedic medical college and hospital,kharghar 
Address  OPD No 18 , Ground floor and Room 207 , second floor ,Department of Kaumarbhritya ,DR G D POL Foundation YMT Ayurvedic medical college and hospital,kharghar,navi mumbai.

Raigarh
MAHARASHTRA
410210
India 
Phone  9579555631  
Fax    
Email  dangevaibhavi7711@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Raghavendra Pandilwar 
Designation  associate professor Kaumarbhritya department  
Affiliation  DR G D POL Foundation YMT Ayurvedic medical college and hospital,kharghar 
Address  OPD No 18 , Ground floor and Room 207 , second floor ,Department of Kaumarbhritya ,DR G D POL Foundation YMT Ayurvedic medical college and hospital,kharghar,navi mumbai.

Raigarh
MAHARASHTRA
410210
India 
Phone  9699365567  
Fax    
Email  raghavendra.pandilwar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vaibhavi Ashok Dange 
Designation  1st year PG Scholar Kaumarbhritya 
Affiliation  DR G D POL Foundation YMT Ayurvedic medical college and hospital,kharghar 
Address  OPD No 18 , Ground floor and Room 207 , second floor ,Department of Kaumarbhritya ,DR G D POL Foundation YMT Ayurvedic medical college and hospital,kharghar,navi mumbai.

Raigarh
MAHARASHTRA
410210
India 
Phone  9579555631  
Fax    
Email  dangevaibhavi7711@gmail.com  
 
Source of Monetary or Material Support  
DR G D POL Foundation YMT Ayurvedic medical college and hospital,kharghar,navi mumbai,Maharashtra 410210 ,India  
 
Primary Sponsor  
Name  Dr Vaibhavi Ashok Dange 
Address  DR G D POL Foundation YMT Ayurvedic medical college and hospital,kharghar,navi mumbai ,Maharashtra 410210 , India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Raghavendra Pandilwar  DR G D POL Foundation YMT Ayurvedic medical college and hospital,kharghar,navi mumbai. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaibhavi Ashok Dange  DR G D POL Foundation YMT Ayurvedic medical college and hospital  OPD No 18 , Ground floor and Room 207 , second floor ,Department of Kaumarbhritya ,kharghar,navi mumbai 410210 .
Raigarh
MAHARASHTRA 
9579555631

dangevaibhavi7711@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:F909||Attention-deficit hyperactivity disorder, unspecified type. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Mahapaishachika Ghrita , Reference: Charak Chikitsa Unmad adhyaya 9/45, Route: Oral, Dosage Form: Ghrita, Dose: 0(ml), Frequency: bd, Bhaishajya Kal: Grasantara bhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: Dose will be calculated using clarks rule as per weight of child .
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1. Patient of ADHD irrespective of sex, religion, socio economic condition etc.
2. Children diagnosed with ADHD as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5 criteria) symptoms 6/9-predominantly inattentive type/predominantly hyperactive and impulsive type/Combined
3. Children aged between 4-16 years.
4. Known case of ADHD.
5. Fulfilling at least 5 out of 9 Lakshana from Unmada Pratyatm lakshan.
 
 
ExclusionCriteria 
Details  1. Known cases of Cerebral palsy, Mental retardation, epilepsy and autism.
2. Known cases of Hearing deficit, congenital anomalies like cleft palate, CHD etc.
3. Severe comorbid psychiatric illness.
4. Known cases of systemic disorders and metabolic disorders.
 
 
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 Attention Deficit Hyperactivity Disorder(ADHD) in children assessed by using DSM5 criteria  follow up -on 0th ,15th ,30nth day of treatment and on 45th day without intervention for 15 days in between . 
 
Secondary Outcome  
Outcome  TimePoints 
1) to study effect of mahapaishachika ghrita, on reducing Attention Deficit Hyperactivity Disorder (ADHD) symptoms.
2) To compare pre & 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.
 
follow up -on 0th ,15th ,30nth day of treatment & on 45th day without intervention for 15 days in between . 
 
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 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 - NO
Brief Summary  
Attention Deficit Hyperactivity Disorder ADHD is behavior disorder which is correlated in Ayurveda with manas roga (psychosomatic disorder. Attention Deficit Hyperactivity Disorder ADHD is one of them which is characterized by a persistent pattern of inattention and/or hyperactivity and impulsivity with male predominance. Attention-deficit hyperactivity disorder ADHD is a brain disorder marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. Inattention means a child wanders off task, lacks persistence, has difficulty sustaining focus and is disorganized. Hyperactivity means a child seems to move about constantly, including in situations in which it is not appropriate; or excessively fidgets, taps or talks. Impulsivity means a child makes hasty actions that occur in the moment without first thinking about them and that may have high potential for harm; or a desire for immediate rewards or inability to delay gratification. An impulsive child may be socially intrusive and excessively interrupt others or make important decisions without considering the long-term consequences.The precise etiological reason for ADHD is uncertain. Strong genetic component, poor synchronization of functioning neurons, and antenatal history of the mother may all contribute to birth complications such prolonged labour, toxemia, and difficult delivery. Drug abuse and addiction of mother are also being recognized as risk factors. Brain traumas, low birth weight, birth asphyxia, trauma, brain abnormalities, lack of family discipline, etc. are known to have some part in its development .Ghrita transports the medicinal qualities of herbs to every tissue in the body since the cell membrane also contains lipid, the lipophilic effect of ghrita makes it easier to move to a target organs and deliver inside the cell. Ghrita is able to penetrate the blood-brain barrier. It improves Dhee, Smriti, and Medha while elucidating the qualities of Ghrita .This Ghrita preparation is particularly said to assist rejuvenate Medha (thinking ability), Buddhi (intellect), and Smriti (memory power). It also aids in the development of children’s bodies. The majority of the constituents in Mahapaishachika Ghrita are naturally occurring Tridosa shamaka, and it comprises a range of medications. About seven Medhya medications that act on the brain through its Prabhava are included in the complete composition.
 
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