Melatonin Immune Boost COVID 19 Study

Melatonin For COVID 19 pre exposure prophylaxis in High Risk population . (MELATONIN IMMUNE BOOST COVID 19 STUDY )

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/025613

Enrollment

200

Registered

2020-06-04

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

None listed

Interventions

Intervention1: Melatonin: Oral melatonin 3 mg at 6 pm daily once x 8 weeks Control Intervention1: Placebo: Placebo for 8 weeks

Eligibility

Inclusion criteria

Inclusion criteria: High groups for COVID 19 related disease Elderly : age > 60 years Diabetes Obesity Heart Failure Immuno supressed patients

Exclusion criteria

Exclusion criteria: Chronic Renal Failure Chronic Hepatic Failure Any hospitalisation for past 3 months Any recent vaccination Nutrition supplements Any addiction Chronic infections live Human immunodeficiency disorder , Hepatitis B,C., etc Any autoimmune disease Irregular sleep pattern Primary immunodeficiency states Vitamin deficiency states

Design outcomes

Primary

Measure	Time frame
SARS-CoV 2 infection rate : Number of confirmed (positive CRP) symptomatic infections in each treatment group Timepoint: 8 weeks	—

Secondary

Measure	Time frame
Frequency of respiratory tract infections during course of study using the â?¨Wisconsin Upper Respiratory Symptom Survey Timepoint: 8 weeks;Change from baseline immune cells and markers after 8 weeks of medications Timepoint: 8 weeks;Number of participants with treatment-related adverse eventsTimepoint: 8 weeks	—

Countries

India

Contacts

Public ContactRohit Walia

All India Institute of Medical Science Rishikesh

rwalia7731@yahoo.in8800492549

Outcome results