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临床试验/NCT07563114
NCT07563114进行中(未招募)不适用

The Use of Rosmarinus Officinalis L. Essential Oil (Camphor and Cineol Chemotypes) in Cognition: a Randomized, Double-blind, Placebo-controlled Study

Federal University of Paraíba1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
63
试验地点
1
主要终点
STROOP TEST

研究概览

简要总结

Aromatherapy is one of the complementary therapies that is carried out through essential oils. The essential oil of Rosmarinus Officinalis L. (rosemary) has been gaining attention in aromatherapy research, as studies have shown that the use of this oil is one of the promising non-pharmacological therapies for cognition. In this way, inhalation of rosemary essential oil is one of the forms of cognitive intervention across different age groups. The study will aim to analyze the effect of rosemary essential oil, with the following chemotypes: camphor and cineole, on the cognitive performance of adults. Significant differences are expected between the control (placebo) and experimental groups, given that studies in humans have already shown significant effects of rosemary essential oil on cognition. Considering the inclusion and exclusion criteria of the study, participants will be allocated to either the control or experimental group. Consequently, the application of the tests will be carried out neuropsychological tests for the pre-test evaluation, followed by aromatherapy (acute phase) and the reapplication of the tests (post-test phase 1). For 14 days, the participants will chronically use rosemary essential oil and at the end they will participate in the reapplication of the neuropsychological tests (post-test phase 2). For inferential analyses, the ANOVA test or its non-parametric equivalent will be used. In addition, linear regressions may be performed to verify how much the essential oil can predict the outcome of the study's dependent variables. Effect Size will also be calculated. Keywords: Chronic intervention; neuropsychology; aromatherapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • 1a Healthy adults
  • 1b should be able to inhale the essential oil

排除标准

  • 2a Neurodegenerative diseases
  • 2b Traumatic brain injury
  • 2c Brain tumors
  • 2d Multiple sclerosis
  • 2e Epileptic seizures
  • 2f Anxiety Disorder
  • 2g Depressive Disorders,
  • 2h Uncontrolled arterial hypertension,
  • 2i nutritional deficiency or thyroid disease.

研究组 & 干预措施

essential oil of Rosmarinus officinalis 1

Experimental

Inhalation of 2 drops of rosemary camphor essential oil for 5 minutes, once a day for 1 week consecutive on a cotton pad followed

干预措施: rosemary1 (Other)

Placebo

No Intervention

Inhalation of 2 drops of sunflower essential oil for 5 minutes, once a day for 1 week consecutive on a cotton pad followed

essential oil of Rosmarinus officinalis 2

Active Comparator

Inhalation of 2 drops of rosemary cineol essential oil for 5 minutes, for once a day for 1 week consecutive on a cotton pad followed

干预措施: rosemary1 (Other)

结局指标

主要结局

STROOP TEST

时间窗: Cognitive tests were administered at the following stages: "Before the intervention (baseline), immediately after the intervention, and 1 week after the intervention."

Unit of measurement: time (seconds)

Subteste Digits of the Test WAIS-III - (Wechsler Adult Scale)

时间窗: Cognitive tests were administered at the following stages: "Before the intervention (baseline), immediately after the intervention, and 1 week after the intervention."

1a. Maximum raw score: 30 1b. Minimum raw score: 2

Subtest Number and Letter Sequence of the WAIS-III Test - (Wechsler Adult Scale)

时间窗: Cognitive test were administered at the following times: "Before the intervention (baseline), immediately after the intervention, and 1 week after the intervention."

1.0 Measurement Units: raw score 1a. Maximum raw score: 21 1b. Minimum raw score: 0

Tower of London

时间窗: Cognitive test were administered at the following times: "Before the intervention (baseline), immediately after the intervention, and 1 week after the intervention."

1.0 Measurement Units: raw score 1a. Maximum raw score: 46 1b. Minimum raw score: 0

Token Test

时间窗: Cognitive test were administered at the following times: "Before the intervention (baseline), immediately after the intervention, and 1 week after the intervention."

1.0 Measurement Units: raw score 1a. Maximum raw score: 36 1b. Minimum raw score: 0

Corsi Blocks

时间窗: Cognitive test were administered at the following times: "Before the intervention (baseline), immediately after the intervention, and 1 week after the intervention."

1.0 Measurement Units: raw score 1a. Maximum raw score: 30 1b. Minimum raw score: 0

Hopkins Verbal Learning

时间窗: Cognitive test were administered at the following times: "Before the intervention (baseline), immediately after the intervention, and 1 week after the intervention."

1.0 Measurement Units: raw score 1a. Maximum raw score: 0 1b. Minimum raw score: 36

次要结局

未报告次要终点

研究者

发起方
Federal University of Paraíba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Heloisa de Freitas Pacífico

Principal Investigator, PhD student in cognitive neuroscience and behavior

Federal University of Paraíba

研究点 (1)

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