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Effects of Orally Administered Thymus Vulgaris Leaves on Memory, Anxiety, Depression, and Sleep Quality in University Students: A Randomized Controlled Trial

Primary Purpose

Memory Dysfunction, Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Thymus vulgaris
Sponsored by
The Hashemite University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Memory Dysfunction focused on measuring Thymus vulgaris leaves, Memory performance, Anxiety, Depression, Sleep

Eligibility Criteria

19 Years - 23 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Health participants Exclusion Criteria: individuals with medical diseases, psychiatric disorders, those using any medications (including complementary and alternative medicines), as well as pregnant and lactating individuals, were excluded from participating

Sites / Locations

  • Faculty of Pharmaceutical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Thymus vulgaris group

control group

Arm Description

500 mg of Thymus vulgaris (capsules) was given orally twice daily

500 mg starch (capsules) was given orally twice daily

Outcomes

Primary Outcome Measures

Memory performance
Prospective and Retrospective Memory Questionnaire (PRMQ) was employed

Secondary Outcome Measures

Anxiety and depression
Anxiety and depression levels were measured using the Hospital Anxiety and Depression Scale (HADS)
Sleep quality
Pittsburgh Sleep Quality Inventory (PSQI) questionnaire was performed

Full Information

First Posted
August 1, 2023
Last Updated
August 9, 2023
Sponsor
The Hashemite University
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1. Study Identification

Unique Protocol Identification Number
NCT05987228
Brief Title
Effects of Orally Administered Thymus Vulgaris Leaves on Memory, Anxiety, Depression, and Sleep Quality in University Students: A Randomized Controlled Trial
Official Title
Effects of Orally Administered Thymus Vulgaris Leaves on Memory, Anxiety, Depression, and Sleep Quality in University Students: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hashemite University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Thymus vulgaris could potentially serve as a safer alternative to stimulant drugs for enhancing memory among university students. Furthermore, Thymus vulgaris may offer additional benefits in terms of reducing anxiety, depression, and improving sleep quality. However, it should be noted that the current research on the effects of orally administered Thymus vulgaris on the brain and nervous system is limited, and further studies are required to fully explore its potential advantages. Therefore, the purpose of this study is to investigate the effects of oral Thymus vulgaris on memory performance, anxiety, depression, and sleep quality in university students.
Detailed Description
Thymus vulgaris belongs to the Lamiaceae family and is a flowering plant. It can be found worldwide, although its origin is in southern Europe [1]. This plant is characterized by its compact, bushy nature and evergreen shrub structure. Its leaves are small, gray-green, highly aromatic, and it produces clusters of purple or pink flowers [2]. Thymus vulgaris is commonly used as a spice to enhance the flavor of food. It is also utilized in the form of dietary supplements; such as capsules or essential oils [3]. Throughout history, Thymus vulgaris has been employed in folk medicine due to its remarkable antimicrobial and anti-inflammatory properties [4]. In Jordanian traditional medicine, it is frequently utilized as an antiseptic, bronchial, sedative, and spasmolytic agent, as well as to improve cognitive function and memory [5-8]. Numerous studies have reported various health benefits associated with Thymus vulgaris leaves, including antioxidant [9], diuretic [10], anti-inflammatory [11], antiviral [12], anti-cancerous [13], cholesterol-lowering [14], glucose-lowering [15], anticonvulsant [16], anti-anxiety [17] and sedative-hypnotic activities [18]. The primary constituents of Thymus vulgaris, notably thymol, p-cymene, γ-terpinene, linalool, and carvacrol, possess various neuropharmacological properties, including anti-anxiety, sedative, anticonvulsant, memory-enhancing, and anti-Alzheimer's disease effects [19]. Asadbegi et al. conducted a study demonstrating that thymol exhibited neuroprotective properties by reducing memory impairment caused by intrahippocampal injection of the amyloid beta (Aβ) peptide in rats fed a high-fat diet [20]. Furthermore, Capibaride et al. confirmed the significant antidepressant-like effect of thymol by observing its ability to reverse behaviors associated with chronic corticosterone exposure and decrease in BDNF levels in female mice [21]. Azizi et al. demonstrated that carvacrol and thymol exerted neuroprotective effects against Aβ25-35-induced damage, potentially through the attenuation of oxidative stress and the modulation of PKC activity, a protein associated with memory function [22]. Additionally, within the monoterpenes and sesquiterpenes, β-myrcene and caryophyllene have been identified as major compounds. β-myrcene is known for its analgesic, anxiolytic, and anti-inflammatory effects [23]. Multiple studies have highlighted the positive impact of Thymus vulgaris on memory, anxiety, and depression. Akan et al. conducted research on rats using the Morris water maze and found that Thymus vulgaris L. exhibited beneficial effects against diabetes mellitus-induced neuropathy and cognitive impairment [24]. They attributed these effects to specific components like thymol, carvacrol, 8-terpinene, p-cymene, and α-pinene present in high amounts in the essential oil composition. Similarly, Rabiei et al. suggested that Thymus vulgaris extract demonstrated anti-amnesic properties in rats with Sco-induced memory deficits, as assessed by the Morris water maze and passive avoidance tests [25]. The authors proposed that this effect could be linked to the extract's antioxidant activity or its influence on the cholinergic system, with carvacrol and thymol playing significant roles based on their chemical composition. Additionally, an ethanol extract derived from Thymus vulgaris leaves displayed an anxiolytic profile in rats during the EPM test, unaffected by locomotor activity [17]. Finally, in the context of Alzheimer's disease, a neurodegenerative disorder involving cholinergic neuron loss, administration of thyme oil to Caenorhabditis elegans enhanced neurotransmission by regulating synaptic acetylcholine levels [26]. The high prevalence of anxiety, depression, and sleep disorders among university students can significantly affect their memory function [27]. Consequently, an increasing number of university students have turned to using stimulant drugs to improve their memory performance and attention, despite the fact that such usage is unauthorized and not intended for therapeutic purposes [28]. However, the use of these drugs is associated with various side effects[29,30]. This has led neuroscience researchers to show a growing interest in identifying cognitive-enhancing drugs that can be safely used by healthy individuals without any detrimental effects. Based on the provided information, it is hypothesized that Thymus vulgaris could potentially serve as a safer alternative to stimulant drugs for enhancing memory among university students. Furthermore, Thymus vulgaris may offer additional benefits in terms of reducing anxiety, depression, and improving sleep quality. However, it should be noted that the current research on the effects of orally administered Thymus vulgaris on the brain and nervous system is limited, and further studies are required to fully explore its potential advantages. Therefore, the purpose of this study is to investigate the effects of oral Thymus vulgaris on memory performance, anxiety, depression, and sleep quality in university students.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Dysfunction, Anxiety, Depression, Sleep
Keywords
Thymus vulgaris leaves, Memory performance, Anxiety, Depression, Sleep

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thymus vulgaris group
Arm Type
Experimental
Arm Description
500 mg of Thymus vulgaris (capsules) was given orally twice daily
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
500 mg starch (capsules) was given orally twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Thymus vulgaris
Intervention Description
500 mg of Thymus vulgaris (capsules) was given orally twice daily
Primary Outcome Measure Information:
Title
Memory performance
Description
Prospective and Retrospective Memory Questionnaire (PRMQ) was employed
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Anxiety and depression
Description
Anxiety and depression levels were measured using the Hospital Anxiety and Depression Scale (HADS)
Time Frame
30 days
Title
Sleep quality
Description
Pittsburgh Sleep Quality Inventory (PSQI) questionnaire was performed
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Health participants Exclusion Criteria: individuals with medical diseases, psychiatric disorders, those using any medications (including complementary and alternative medicines), as well as pregnant and lactating individuals, were excluded from participating
Facility Information:
Facility Name
Faculty of Pharmaceutical Sciences
City
Zarqa
ZIP/Postal Code
13133
Country
Jordan

12. IPD Sharing Statement

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Effects of Orally Administered Thymus Vulgaris Leaves on Memory, Anxiety, Depression, and Sleep Quality in University Students: A Randomized Controlled Trial

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