| 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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 . |
|
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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. |