Health Condition 1: null- Moderate and severe stable COPD.
Conditions
Interventions
Intervention1: The IP Melatonin 3 mg that means N-acetyl-5-methoxy tryptamine (5 mg) tablet will be used in this study.: 3 mg IP will be advised after the baseline visit.The drug would be used for 4 w
Sponsors
Artemis Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with or without smoking history along with the diagnosis of moderate to severe COPD along with the treatment of LABA/LAMA or LABA/ICS and LAMA 2.Patients who have not had an exacerbation of COPD for at least 6 wks 3. Willing to give consent
Exclusion criteria
Exclusion criteria: 1.Concurrent Obstructive Sleep Apnoea 2.Heart failure 3.Uncontrolled diabetes 4.Primary insomnia 5.Any other pulmonary disease 6.Patients who exacerbate during study participation 7.Patients on Long term Oxygen therapy 8.Patients who are on BIPAP/CPAP 9.Patients who are on Sleeping medications (hypnotics/opioids, pain killers-pregabalin etc)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Activity Data (number of steps in a day) before and after Melatonin 2) Changes in Hindi Mini Functional Outcome Sleep Questionnaire (FOSQ) Timepoint: 1 yr | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in modified Hindi Epworth Sleepiness score -1 (ESS-1)Timepoint: 1 yr | — |
Countries
India
Contacts
Public ContactDr Himanshu Garg
ARTEMIS HOSPITALS
Outcome results
None listed