Comparing Ayurveda and Standard Treatment for Managing ADHD in Children: A Clinical Trial

Not yet recruiting

• Conditions: Attention-deficit hyperactivity disorder, unspecified type. Ayurveda Condition: unmad,

• Registration Number: CTRI/2025/04/085991
• Lead Sponsor: Dr Sonu Prakash

Brief Summary

**Title**: *Comparative Study on the Effect of Ayurveda Treatment Protocol and Methylphenidate in the Management of ADHD in Children*

**Background**: Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder in children, characterized by inattention, hyperactivity, and impulsivity. While methylphenidate is the standard pharmacological treatment, it is associated with significant side effects. Due to these concerns, many parents seek alternative therapies, including Ayurveda. Ayurvedic texts compare ADHD to *Unmada*, and suggest various therapies for its management.

**Aim**: To evaluate and compare the effectiveness of an Ayurveda treatment protocol and methylphenidate in managing ADHD in children.

**Objectives**:

- **Primary**: Compare outcomes using the SNAP IV Rating Scale.

- **Secondary**: Assess reaction time (Vernier Chronoscope), functional impairment (Weiss Scale), comorbidities (Kiddie-SADS), quality of life (PedsQL), and severity/improvement (CGI scales).

**Methodology**:

- **Design**: Randomized Controlled Clinical Trial

- **Participants**: 80 children aged 6–12 years with ADHD (diagnosed per DSM-5), randomized into two groups

- **Setting**: KLE Shri BMK Ayurveda Hospital, Belagavi

- **Duration**: 28 months

- **Groups**:

- **Group A**: Ayurveda protocol including Abhyanga, Swedana, Basti, Shirodhara, Nasya, and oral Jatamansi

- **Group B**: Oral methylphenidate (1 mg/kg/day)

- **Duration of Intervention**: 60 days

- **Outcome Measures**: Clinical scales, reaction time, comorbidities, and quality of life

**Inclusion Criteria**: Children aged 6–12 with DSM-5 ADHD diagnosis.

**Exclusion Criteria**: Children with infections, comorbid neurological or congenital conditions, or those on current ADHD medication.

**Significance**: This study aims to provide evidence for the efficacy and safety of Ayurveda as an alternative to conventional pharmacotherapy in managing ADHD

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-29
• Study Start: 2025-05-18

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1. Children of either sex between the age group of 6-12 years.
• 2. Children fulfilling the DSM-V diagnostic criteria for diagnosis of ADHD.

Exclusion Criteria

• 1. Children with an acute or chronic, local or systemic infection will be excluded.
• 2. Children who are currently using other medications will be excluded owing to the possibility of drug interaction.
• 3. Known case of cerebral palsy, mental retardation and epilepsy, hearing defect etc.
• 4. Children with obvious congenital anomalies like cleft palate, CHD etc.
• 5. Children who have received any form intervention for ADHD in last 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
management of ADHD in children assessed through SNAP IV Rating Scale.	baseline, 7th day, 30th day, 60th day
To compare the effect of Ayurveda Treatment protocol and Methylphenidate in	baseline, 7th day, 30th day, 60th day

Secondary Outcome Measures

Name	Time	Method
1. To evaluate the effect of Ayurveda Treatment protocol in management of ADHD in children	by assessing the reaction time through Vernier Chronoscope

Trial Locations

Locations (1)

Kahers Shri B.M.K Ayurveda Mahavidyalya; 🇮🇳 Belgaum, KARNATAKA, India

Kahers Shri B.M.K Ayurveda Mahavidyalya

🇮🇳Belgaum, KARNATAKA, India

Dr Sonu Prakash

Principal investigator

9560225819

sp2277423@gmail.com