Efficacy of Ayurvedic treatment protocol in the management of Attention-Deficit Hyperactivity Disorder (ADHD) – An open labelled single arm clinical trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 1.NCHQ FOR ADHD (BT and AT)
Study Overview
Brief Summary
Efficacy of Ayurvedic treatment protocol in the management of Attention-Deficit Hyperactivity Disorder (ADHD) – An open labelled single arm clinical trial
•Introduction: - ADHD characterized by inattention, including increased distractibility & difficulty sustaining attention; poor impulse control and decreased self-inhibitory capacity; and motor over activity and motor restlessness. Above characteristics of ADHD point towards imbalance of Shareerika (specifically Vata) and Manasika (specifically Raja) Dosha. In modern practice ADHD treatment is based on psychiatric counselling and psycho stimulant medication which have safety concerns. Ayurveda has mentioned Medhya Rasayana drugs that enhance concentration, retention abilities of brain. Rasayana Medhya drugs may be effective in ADHD as the disorder affects the Manasik Bhavas in a child influencing both Shareerika and Manasika Dosha. Considering the same, we hypothesize that they may be effective in ADHD. As the therapy requires to calm the child and increase span of concentration.
•Rationale for selection of the topic: - According to World Health Organization, in 2020, the number of people living with mental disorders rose significantly because of the COVID-19 pandemic. Initial estimates show a 26% and 28% increase respectively for anxiety and major depressive disorders in just one year These Children constitute about 40% of our population and in Indian studies the reported rate of psychopathology among children is 5-15%. A time has thus arrived for theory and practice of child psychology, child psychiatry and paediatric behavioural medicine to be adapted to ground realities and priorities in India.
•Aim and Objectives: - To evaluate the efficacy of Ayurvedic treatment protocol in Attention-Deficit Hyperactivity Disorder (ADHD) in children
•Materials and Methods: - 20 desired Patients of ADHD will be volunteers which are between age group of 6 to 12 year and fulfils the Inclusion and Exclusion criteria. Volunteers will undergo the treatment protocol which consists of Deepana Pachana by Hingwashtaka churna, Shirodhara by Balakwatha, Shamana Aushadha And Pratimarsha Nasya with Panchagavyaghrita
•Results and Discussion: Data generated during the above study will be present in a Systemic manner as shall be analysed statistically. Where the important points of the Conceptual study, Analytical study, Pharmacological study will be discussed.
Side Effects: These drugs have no known unwanted effects. Adverse Drug Reactions if any are observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 6.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Children between the age group of 6 to 12 years irrespective of their sex, religion, caste, etc.
- •having fulfill DSM-V criteria.
Exclusion Criteria
- •1.Children below 6 years & above 12 years of age.
- •2.Mental disorders like conduct disorder, anxiety, depressive disorders, obsessive disorders & compulsive disorder.
- •3.Children with schizophrenia.
- •4.Children having a medical illness like hearing loss, hypothyroidism, genetic disorder & seizure disorder.
- •5.Children having congenital deformity or Muscular dystrophy.
Outcomes
Primary Outcomes
1.NCHQ FOR ADHD (BT and AT)
Time Frame: 33 days
2.IQ assessment by Draw a Person test (BT and AT)
Time Frame: 33 days
Secondary Outcomes
- 1.Improvement in school performance and health status of the children(33 days)