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EFFECT OF TABLET MELATONIN FOR SLEEP PROBLEMS IN CHILDREN WITH CEREBRAL PALSY

ROLE OF ORAL MELATONIN SUPPLEMENTATION IN CHILDREN WITH CEREBRAL PALSY FOR SLEEP DISTURBANCES;A RANDOMISED CONTROLLED TRIAL - MESCP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027813
Enrollment
120
Registered
2020-09-15
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: G804- Ataxic cerebral palsy Health Condition 2: G803- Athetoid cerebral palsy Health Condition 3: G809- Cerebral palsy, unspecified Health Condition 4: G808- Other cerebral palsy Health Condition 5: G801- Spastic diplegic cerebral palsy Health Condition 6: G802- Spastic hemiplegic cerebral palsy Health Condition 7: G800- Spastic quadriplegic cerebral palsy

Interventions

Intervention1: ORAL MELATONIN: MELATONIN IS A SUBSTANCE NATURALLY PRODUCED IN HUMAN PINEAL GLAND THAT HELPS TO REGULATE OUR SLEEP AND WAKE CYCLE THROUGH ITS ACTION ON SUPRACHISMATIC NUCLEUS IN THE HYP

Sponsors

GIRE POOJA K
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ALL THE CHILDREN DAIGNOSED WITH CEREBRAL PALSY AGE 3YRS TO 12 YRS WITH SLEEP PROBLEMS DEFINED BY PRESENCE OF ONE OR MORE OF THE FOLLOWING ; 1.WHO DID NOT FALL ASLEEP AFTER 1HR OF LIGHTS OFF. 2.WAKES UP ONCE OR MORE DURING NIGHT . 3.GETS LESS THAN 6HRS OF SLEEP 4.CHILDREN WHO FAIL BEHAVIORAL MANAGMENT STRATERGIES FOR SLEEP DISTURBANCES.

Exclusion criteria

Exclusion criteria: 1.CHILDREN ALREADY TREATED WITH MELATONIN OR TAKING MELATONIN. 2.CHILDREN HAVING SYMPTOMS AND SIGNS OF OBSTRUCTIVE SLEEP APNEA. 3.KNOW ALLERGY TO MELATONIN. 4.CHILDREN WITH NOCTURNAL SEIZURES. 5.CHILDREN WHOSE PARENTS OR CARETAKERS ARE NOT WILLING TO PARICIPATE IN STUDY

Design outcomes

Primary

MeasureTime frame
TO IMPROVE TOTAL DURATION OF SLEEP BY 1 HOUR IN MELATONIN GROUP AS COMPARED TO PLACEBO GROUP.Timepoint: 3 MONTHS

Secondary

MeasureTime frame
TO DECREASE SLEEP LATENCY IN MELATONIN GROUP AS COMPARED TO PLACEBO GROUPTimepoint: 3 MONTHS;TO STUDY SIDEEFFECTS OF MELATONIN IF ANYTimepoint: 3MONTHS

Countries

India

Contacts

Public ContactGIRE POOJA K

GOVERNMENT MEDICAL COLLEGE AND HOSPITAL AURANGABAD

smita.mundada@gmail.com9224287215

Outcome results

None listed

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