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Clinical Trials/CTRI/2025/01/078848
CTRI/2025/01/078848Not yet recruitingPhase 2

Evaluation of Shiroabhyanga with Panchgavya Ghrita Matra Basti in the Management of Attention Deficit Hyperactivity Disorder

Dr Puja CN Pathak1 site in 1 country100 target enrollmentStarted: January 21, 2025Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Panchgavya Ghrita Matrabasti alongwith Brahmi Taila Shiro Abhyanga is effective in the management of ADHD in children.

Study Overview

Brief Summary

The global prevalence of ADHD in children and adolescents is estimated to be around 8.0 %, with a higher occurrence in males. In India, the prevalence varies between 2% to 17%.3,4

The immediate and long-term consequences of untreated or under-treated ADHD can be quite severe for children, their families, and society .5 Covid -19 pandemic have shown significant adverse impacts on a child with neurodevelopmental conditions such as ADHD

In Modern Science, the treatment of ADHD involves Methylphenidate and Amphetamine, which are psychostimulant drugs. Adverse reactions of the drug includes decreased appetite, irritability, tics, sleep issues, with an increased risk of cardiovascular events. Prolonged use, causes slowing of physical growth which is transient with an unclear cause6

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.7

In Ayurveda there are many drugs like Kalyanaka Ghrita, Panchgavya Ghrita, Brahmi Churna, Vachadi churna etc. that are known to be used in Manovaha srotas vikaras as aushadhi and may be helpful in handling ADHD like conditions more effectively.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
6.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Participants in between age group of 6-12 years.
  • All participants will be included irrespective of Sex, religion, and socioeconomic status.
  • Children without any acute illness and brain trauma.
  • Children in whom parents are willing to sign the written consent form to participate.

Exclusion Criteria

  • Children with an acute or chronic, local or systemic infection will be excluded.
  • Known case of cerebral palsy, mental retardation and epilepsy, hearing defect etc.
  • Children who have received any form of modern intervention for ADHD in last 1 year.
  • Children in whom parents are hesitant to sign the written consent form to participate.

Outcomes

Primary Outcomes

Panchgavya Ghrita Matrabasti alongwith Brahmi Taila Shiro Abhyanga is effective in the management of ADHD in children.

Time Frame: 30 days of intervention and | frequency of assessment- 0th , 30th , 60th , 90th day.

Secondary Outcomes

  • Panchgavya Ghrita Matrabasti alongwith Brahmi Taila Shiro Abhyanga is effective when compared with oral administration of Panchgavya Ghrita with Brahmi Taila Shiro Abhyanga in the management of ADHD in children.(30 days of intervention and)

Investigators

Sponsor
Dr Puja CN Pathak
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Puja CN Pathak

Sri Sri College of Ayurvedic Science and Research Hospital, Cuttack, Odisha

Study Sites (1)

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