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Clinical Trials/CTRI/2025/10/096580
CTRI/2025/10/096580Not yet recruitingPhase 2/3

Efficacy of Mahapaishachika Ghrita in management of Attention deficit hyperactivity disorder[ADHD]w.s.r.To Unmad -An open labelled single arm clinical study.

Dr Vaibhavi Ashok Dange1 site in 1 country30 target enrollmentStarted: January 1, 2026Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Reduction in the clinical features of Attention Deficit Hyperactivity Disorder(ADHD) in children assessed by using DSM5 criteria

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
4.00 Year(s) to 16.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patient of ADHD irrespective of sex, religion, socio economic condition etc.
  • 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
  • Children aged between 4-16 years.
  • Known case of ADHD.
  • Fulfilling at least 5 out of 9 Lakshana from Unmada Pratyatm lakshan.

Exclusion Criteria

  • Known cases of Cerebral palsy, Mental retardation, epilepsy and autism.
  • Known cases of Hearing deficit, congenital anomalies like cleft palate, CHD etc.
  • Severe comorbid psychiatric illness.
  • Known cases of systemic disorders and metabolic disorders.

Outcomes

Primary Outcomes

Reduction in the clinical features of Attention Deficit Hyperactivity Disorder(ADHD) in children assessed by using DSM5 criteria

Time Frame: follow up -on 0th ,15th ,30nth day of treatment and on 45th day without intervention for 15 days in between .

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Dr Vaibhavi Ashok Dange
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Vaibhavi Ashok Dange

DR G D POL Foundation YMT Ayurvedic medical college and hospital,kharghar

Study Sites (1)

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