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A Study to know the effect of drug "Melatonin" on Sleep in patients with Idiopathic Parkinsonâ??s disease

Effect of Melatonin on Sleep in Idiopathic Parkinsonâ??s disease: A Randomized Double blind Placebo controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056190
Enrollment
86
Registered
2023-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: G20- Parkinsons disease

Interventions

Intervention1: Effect of Melatonin on Sleep in Idiopathic Parkinsonâ??s disease: A Randomized Double blind Placebo controlled trial: Study will be started after obtaining Institute ethics committee ap

Sponsors

Jawaharlal Institute Of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA 1. Patients who are diagnosed with Idiopathic Parkinsonâ??s Disease 2. Patients with IPD with age 30 years and above

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
1.To find out the difference in Sleep quality using PSQI between patients with IPD using Melatonin and placebo 2.To find out the difference in Daytime somnolence using Epworth sleepiness scale between patients with IPD using Melatonin and placebo Timepoint: start date-09-05-2022 expected end date-09-11-2023—

Secondary

MeasureTime frame
1. To find out the differences in Polysomnographic parameters like sleep latency, total sleep time, sleep efficiency and sleep fragmentation between patients with IPD using Melatonin and placebo. 2. To find out the difference in Quality of life using Parkinsonâ??s disease quality of life questionnaire (PDQ-39) between patients with IPD using Melatonin and placebo. 3. To find out the difference in Non motor symptoms using Non motor symptoms scale [NMSS] between patients with IPD using Melatonin and placebo. 4. To find out the difference in motor symptoms using Unified parkinsons disease rating scale- UPDRS III between patients with IPD using Melatonin and placebo Timepoint: start date-09-05-2022 expected end date-09-11-2023—

Countries

India

Contacts

Public ContactKADARLA SHIVASAIKRISHNA

Jawaharlal Institute Of Postgraduate Medical Education and Research,Puducherry

ramkumar.sugumaran@gmail.com9894891561

Outcome results

None listed

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