clinical trial on Attention Deficit Hyperactivity Disorder subject
- Conditions
- Health Condition 1: F901- Attention-deficit hyperactivity disorder, predominantly hyperactive type
- Registration Number
- CTRI/2023/05/052517
- Lead Sponsor
- Jagdale industries pvt. Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
i. Children aged 6 to 12 years with mild to moderate ADHD.
ii. Diagnosis of ADHD according to DSM-5 (Diagnostic and Statistical Manual of
Mental Disorders-5) criteria.
iii. Children with low IQ assessment score (IQ range below 70) as per ICD-10.
iv. Subjects willing to consume Mulmina Apple drink regularly.
v. Agree to follow protocol procedures and come for follow up visits.
1.Children having cerebral palsy physical disability and children requiring IEP with epilepsy will be excluded from the study
2.Patients with preexisting severe systemic disease necessitating long term medication.
3.Any major medical comorbid conditions
4.Evidence of significant uncontrolled co morbid disease which in the investigators opinion would jeopardize patient participation
5.Any onco other neurological congenital or acquired vascular or systemic disorder which could affect any of the efficacy assessments.
6.Participation in the current or previous treatment with any approved or investigational health supplements during the past 1 month
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To Evaluate the safety and efficacy of Mulmina Apple in c h i l d r e n with <br/ ><br>ADHD.Timepoint: Day 0,Day 30 Day 60 and Day 90
- Secondary Outcome Measures
Name Time Method 1.Assessment on ADHD rating scale <br/ ><br>2.Clinical Global Impression of Severity (CGI-S). <br/ ><br>3.Clinical Global Impression-Improvement (CGI-I). <br/ ><br>4.Conners Parent Rating Scale (CPRS) ScoresTimepoint: Day 0,Day 30 Day 60 and Day 90