To study the effect of New Ayurveda treatment and existing Ayurveda Treatment combined with behavioral therapy in the treatment of poor Attention and Hyperactivity in children aged 6 to 11 years.

Phase 3

Not yet recruiting

• Conditions: Attention-deficit hyperactivity disorder, combined type. Ayurveda Condition: UNMADAH,

• Registration Number: CTRI/2023/03/050257
• Lead Sponsor: Govt Ayurveda College Thiruvananthapuram

Brief Summary

Attention deficit hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood and can profoundly affect the academic achievement, well-being and social interactions of the children. The clinical study will be carried out in the outpatient wing of Department of  Kaumarabhrithya at Government Ayurveda College Hospital for women and children, Poojappura Thiruvananthapuram. Study population is Children with ADHD aged 6-11 years. Block Randomization will be used. Sample size calculated is 63 in each group.. The total duration of treatment period will be for 60 days and follow up period will be for 60 days. Trial group will be given a new treatment protocol including  internal medication and external procedures and control group will be given a standard protocol including internal medication and external procedures. The control group and study group will be given behavioral therapy during treatment period and follow up period. Severity of Attention Deficit, Hyperactivity, impulsivity will be measured after the  treatment period and after the  follow up period.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-26
• Study Start: 2023-06-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

1.The inclusion criteria for recruitment will be based on the DSM5 diagnostic criteria for ADHD.

Exclusion Criteria

• 1)Diagnosed cases of autism and mental retardation.
• 2)Severe ADHD receiving modern medicine pharmacotherapy.
• 3)Participants will be excluded if they have a history of or have a current heart disease, high blood pressure, diabetes mellitus, a health condition that would affect food metabolism including food allergies, kidney disease, liver disease, and gastrointestinal diseases.
• 4)Children who have contraindicated for snehana and have recurrent respiratory tract infections.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improve the attention span	1st day - Initial assessment | 60th day - After treatment period | 120th day - After follow up period.
Reduce the impulsivity.	1st day - Initial assessment | 60th day - After treatment period | 120th day - After follow up period.
Reduce the Hyperactivity	1st day - Initial assessment | 60th day - After treatment period | 120th day - After follow up period.
(Based on the parental observation assessment scale)	1st day - Initial assessment | 60th day - After treatment period | 120th day - After follow up period.

Secondary Outcome Measures

Name	Time	Method
1. The secondary outcome measurements are improvement in the attention span, reduce hyperactivity and impulsivity. It will be assessed by using a psychologist observation assessment scale, Attention-Deficit/Hyperactivity Disorder Test – Second edition.	2. severity of illness, Global improvement in treatment, and theraputic effect will be assessed by using Clinical Global Impression scale.

Trial Locations

Locations (1)

Govt Ayurveda College Hospital for Women and Children; 🇮🇳 Thiruvananthapuram, KERALA, India

Govt Ayurveda College Hospital for Women and Children

🇮🇳Thiruvananthapuram, KERALA, India

Dr Sohini S

Principal investigator

9447657471

drsohini30@gmail.com