Phase 4
Completed N=68
Melatonin in Smoke-induced Vascular Injury
Smoking · Vascular System Injuries
Source: ClinicalTrials.gov NCT02591238 ↗
Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Fbg. — 2.76; 2.38; 2.89; 2.49 g/L
Summary
The main purpose of this study was to evaluate the effects of melatonin in the regulation of the vascular injury in smokers through population-based, randomized, double-blind, placebo-controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Fbg. |
2.76; 2.38; 2.89; 2.49 | — |
| PRIMARY Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Glu. |
4.4; 4.24; 5.02; 4.79 | — |
| PRIMARY Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of FFA. |
389; 382; 499; 425 | — |
| PRIMARY Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TC. |
4.51; 4.5; 4.74; 4.45 | — |
| PRIMARY Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TG. |
1.21; 1.23; 1.42; 1.41 | — |
| PRIMARY Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of LDL-C. |
1.85; 1.95; 2.2; 2.19 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy smokers：must above 10 cigarettes per day, at least 1 year
- Healthy non-smokers
Exclusion Criteria
- Cardiovascular disease
- Systolic blood pressure above 140 mm Hg
- Diastolic blood pressure above 90 mmHg
- Psychiatric disorders
- Cancer
- Pregnant
- Lactating
- Taking antipsychotic drugs orally during the 2 weeks of the trial
Data sourced from ClinicalTrials.gov (NCT02591238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.