To compare effectiveness of 3mg versus 5mg Melatonin in patients of insomnia

To study comparative efficacy and safety of melatonin 3mg vs 5mg in patients of insomnia: A randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070440

Enrollment

Registered

2024-07-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Health Condition 1: G470- Insomnia

Interventions

Intervention1: MELATONIN 3mg: Group A 31 patients Tab Melatonin 3mg once daily (Bed time) will be given for two weeks and Group B of 31 patients Tab Melatonin 5mg once daily for two weeks Control In

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with Primary Insomnia Disorder as per DSM-5 diagnostic Criteria. 2. Patients of either Sex with age above 18 years. 3. Patients not on any other Insomnia Medications.

Exclusion criteria

Exclusion criteria: 1. Patients with Insomnia refractory or Secondary Insomnia. 2. Patients with Insomnia as side effect to other Medications. 3. Patients already on Insomnia Treatment. 4. Patients unwilling or unable to comply with the study Proceedings. 5. Pregnant and Lactating mothers

Design outcomes

Primary

Measure	Time frame
To determine the comparative efficacy and safety of 3mg Melatonin versus 5mg Melatonin in insomnia patients.Timepoint: Day 1, Day 14	—

Secondary

Measure	Time frame
To assess quality of life after use of Melatonin 3mg vs 5mg in insomnia patient.Timepoint: Day 1, Day 14	—

Countries

India

Contacts

Public ContactDr Shivani Sharma

Government Medical College and Rajindra Hospital Patiala

jsjasbir9@gmail.com9417212020

Outcome results

None listed

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