Melsoma in Pediatric ADHD Patients

Safety and Efficacy of Melsoma Nano Spray for Treating Sleep Disturbances in Children with ADHD - MELSOMA IN ADHD

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/12/030019

Enrollment

Registered

2020-12-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: F900- Attention-deficit hyperactivity disorder, predominantly inattentive type

Interventions

Intervention1: Melsoma Nano Spray: Melsoma Nano Spray should be Sprayed (2-3 sprays under tongue daily at night) 30 - 60 minutes before going to bed. Control Intervention1: NOT APPLICABLE: NOT APPLICA

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children who meet DSM-5 criteria for ADHD. 2.ADHD patients with the complaints of sleep disorder. 3.Patients who are not on any sedating drugs and having complaints of sleep disturbances. 4.Willingness and able to give informed consent, and comply with requirements for participation in the study

Exclusion criteria

Exclusion criteria: 1.Children with other psychiatry and medical illness will not be included.

Design outcomes

Primary

Measure	Time frame
To determine the changes in the severity of insomnia by using Insomnia Severity Index (ISI) scale.Timepoint: 6 MONTHS	—

Secondary

Measure	Time frame
To document any adverse events associated with the use of Melsoma Nano SprayTimepoint: 6 MONTHS	—

Countries

India

Contacts

Public ContactDr Mona P Gajre

LTMMC AND LTMGH

monapote@yahoo.co.in9820407240

Outcome results

None listed

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