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A Clinical Study to compare efficacy of add-on Ayurveda treatment versus Allopathy treatment in Attention deficit hyperactivity disorder.

Evaluating the efficacy of ayurvedic intervention as add on to conventional treatment and explore the interaction of epigenetics, neuro/gut biomarkers and neuroimaging in pediatric ADHD (Attention Deficit Hyperactivity Disorder)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035308
Enrollment
160
Registered
2021-07-30
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F90- Attention-deficit hyperactivity disorders

Interventions

Intervention1: Add-on Ayurveda intervention to Conventional treatment: 1) Tablet Ayushmana - 2 tablets twice a day. 2) Bramha Rasayana - 5 grams twice a day. 3) Jyotishmati Taila - 5 drops twice a day

Sponsors

Central Council for Research in Ayurvedic Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: � Children and adolescents of both sex in age group of 6-15 years � Fulfilling DSM -5 criteria for the diagnosis of ADHD � Patients receiving treatment as per Standard of care. � Patients or parent/caregiver without any psychotic disease or any mental situation which may cause the concern to properly complete the questionnaires. � Patients whose can understand and fill up required forms.

Exclusion criteria

Exclusion criteria: 1. Known or suspected severe mental retardation or significant learning disorder & Children with co-existing moderate ââ?¬â?? severe Neuro-psychological conditions or autism spectrum disorder. 2. Subjects who require drug therapy or hospitalization for treatment of a chronic psychiatric illness. 3. Patient with inability to swallow the medication whole, and those with any unstable medical illness. 4. Parents who do not give consent for the study.

Design outcomes

Primary

MeasureTime frame
1) Change in Conners Parent Rating Scale - Revised. 2) Change in Conners Teachers Rating Scale - Revised.Timepoint: 6 Months.

Secondary

MeasureTime frame
Change in Gut MicrobiotaTimepoint: 6 months;Change in methylation pattern in epigenomeTimepoint: 6 months;Change in modified AIIMS-INCLEN Diagnostic tool for ADHD.Timepoint: 6 months;Change in neuropsychological functions 1) assessed on children (arousal of attention; reaction time; sustained attention; delay aversion; planning; and executive functions such as, working memory, cognitive inhibition, set/task shifting) 2) changes in parent�s report on the executive functions of their childrenTimepoint: 6 months;Change in T scores of Child Behaviour Check List (CBCL)Timepoint: 6 months;Changes in biomarkers of neurological implications BDNF, beta endorphins and Telomere shorteningTimepoint: 6 months;Changes in inter-relationships among the gut and neurological biomarkersTimepoint: 6 months;Changes in modulation of the functional brain network connectivity (during resting-state and stop-signal response inhibition task)Timepoint: 6 months;Safety of Ayurveda interventions assessed clinically and in biochemical parametersTimepoint: 6 months

Countries

India

Contacts

Public ContactDr Kishore Kumar Ramakrishna

National Institute of Mental Health and Neurosciences

sagarjohn@gmail.com9686062710

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026