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clinical trial on Attention Deficit Hyperactivity Disorder subject

A prospective, multi-centre, randomized, parallel arm, open label, control group study to evaluate the efficacy of Mulmina Apple in children with mild to moderate Attention Deficit Hyperactivity Disorder (ADHD).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052517
Enrollment
100
Registered
2023-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: F901- Attention-deficit hyperactivity disorder, predominantly hyperactive type

Interventions

Intervention1: Receiving SoC Plus Mulmina Apple Ready to drink: Dosage Form:Oral Drink Dosage: 3 packs / day Duration: 3 Tetra Packs of 200 mL each per day for 90 days. Control Intervention1: Receivi

Sponsors

Jagdale industries pvt. Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To Evaluate the safety and efficacy of Mulmina Apple in c h i l d r e n with ADHD.Timepoint: Day 0,Day 30 Day 60 and Day 90—

Secondary

MeasureTime frame
1.Assessment on ADHD rating scale 2.Clinical Global Impression of Severity (CGI-S). 3.Clinical Global Impression-Improvement (CGI-I). 4.Conners Parent Rating Scale (CPRS) ScoresTimepoint: Day 0,Day 30 Day 60 and Day 90—

Countries

India

Contacts

Public ContactMr Raghavendra K V

Radiant research services pvt. Ltd.

surya.ashok@gmail.com9880999297

Outcome results

None listed

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