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Clinical Trials/CTRI/2024/11/076873
CTRI/2024/11/076873RecruitingNot Applicable

Evaluation Of Mahapaisachika Ghrita Pratimarsha Nasya And Tungadhrumadi Taila Siropichu In The Management Of Adhd In Children – A Randomised Controlled Clinical Trial

KLE Shri B M Kankanawadi Ayurveda Hospital1 site in 1 country30 target enrollmentStarted: January 1, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
There might be significant effect of Mahapaishachika ghrita pratimarsha nasya and

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

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

Inclusion Criteria

  • Children of either sex between the age group of 4-16 years Children fulfilling the DSM V diagnostic criteria for diagnosis of ADHD.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

There might be significant effect of Mahapaishachika ghrita pratimarsha nasya and

Time Frame: 0 day | 7 days | 15 days | 30 days

Tungadhrumadi taila siropichu in the management of ADHD in children

Time Frame: 0 day | 7 days | 15 days | 30 days

Measured by changes in the Vanderbilt ADHD assessment criteria

Time Frame: 0 day | 7 days | 15 days | 30 days

Secondary Outcomes

  • There might be significant effect of Mahapaishachika ghrita pratimarsha nasya and(Tungadhrumadi taila siropichu in the management of ADHD in children)

Investigators

Sponsor
KLE Shri B M Kankanawadi Ayurveda Hospital
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Brihathi Bala V J

KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya

Study Sites (1)

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