Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty

NCT07732725 · tracked via the Priya Life Science Egypt tracker

Sponsor

Benha University

Phase

Phase EARLY_PHASE1

Started

2026-08-04

Last updated

2026-07-29

Condition(s) studied

Sleep Disturbance

Investigational drug(s) / intervention(s)

Melatonin 5 MG →Melatonin 10 MG →Placebo

Melatonin 5 MG: Melatonin 5 mg and one placebo sugar tablet oral tablet, two hours preoperatively and for 14 nights postoperatively.

Melatonin 10 MG: Two melatonin 5 mg oral tablet, two hours preoperatively and for 14 nights postoperatively.

Placebo: Two placebo sugar tablets, two hours preoperatively and for 14 nights postoperatively.

Study summary

Considering the fact that melatonin was safely and effectively used in higher doses in multiple surgical conditions , the present study hypothesized that increasing melatonin dose in THA would have better benefits for patients.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Elective unilateral total hip arthroplasty. Exclusion Criteria: * Revision arthroplasty * documented sleep disorders requiring treatment, * use of other sleep medications preoperatively * known melatonin allergy or contraindication.

Primary outcome measure(s)

Sleep Quality — 14 days
Patient-Reported Outcomes Measurement Information System (PROMIS) for sleep quality

Trial sites (1)

Facility	City	Region	Status
Benha Univeristy	Banhā	Qalyobua

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07732725 on ClinicalTrials.gov ↗ ← All trials in Egypt