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Management of cancer related insomnia: A comparative study between melatonin and zolpidem

Comparison of effectivity and adverse effects of two different doses of melatonin with zolpidem on insomnia in cancer patients: A prospective, comparative, interventional study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063740
Enrollment
108
Registered
2024-03-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: D499- Neoplasm of unspecified behavior of unspecified site

Interventions

Intervention1: 1) MELATONIN 3mg 2) melatonin 5mg 3) ZOLPIDEM 5mg: to compare the adverse effects and effectivity of zolpidem and melatonin there will be 3 groups 1) melatonin 3mg 2) melatonin 5mg 3)

Sponsors

nil
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Change in Pittsburgh sleep quality index score Timepoint: baseline,2,4 and 6 weeks

Secondary

MeasureTime frame
Change in Hospital Anxiety Depression Score Timepoint: 2 weeks 4 weeks 6 weeks

Countries

India

Contacts

Public ContactDR YOGENDRA SINGHAL

SAWAI MAN SINGH MEDICAL COLLEGE AND ATTACHED HOSPITAL JAIPUR

singhalyogi@yahoo.co.in9414850381

Outcome results

None listed

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