Management of cancer related insomnia: A comparative study between melatonin and zolpidem
Phase 4
- Conditions
- Health Condition 1: D499- Neoplasm of unspecified behavior of unspecified site
- Registration Number
- CTRI/2024/03/063740
- Lead Sponsor
- nil
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age between 20 and 65 years
Registered in Palliative Medicine Department
Suffering from a histologically diagnosed cancer
Patients with sleep disturbance with a score 5 or higher on Pittsburgh sleep quality index (PSQI)
Patient giving written informed consent for this study
Patient having adequate pain relief and no history of dyspnoea
Exclusion Criteria
Patients with previous psychiatric disorder
Patients on any sedatives/ hypnotics
Patients in anti-anxiety medications
Patient on anti-psychiatric treatment
Patient having language and communication difficulties
Patients using any kind of sleeping aids
Having used melatonin for last one month
Pregnant and lactating women
Patients having severe liver and renal dysfunction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Pittsburgh sleep quality index score <br/ ><br> <br/ ><br>Timepoint: baseline,2,4 and 6 weeks <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Change in Hospital Anxiety Depression Score <br/ ><br>Timepoint: 2 weeks <br/ ><br>4 weeks <br/ ><br>6 weeks