xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05987228</url>
    </required_header>
    <id_info>
      <org_study_id>22/6/2022/2023</org_study_id>
      <nct_id>NCT05987228</nct_id>
    </id_info>
    <brief_title>Effects of Orally Administered Thymus Vulgaris Leaves on Memory, Anxiety, Depression, and Sleep Quality in University Students: A Randomized Controlled Trial</brief_title>
    <official_title>Effects of Orally Administered Thymus Vulgaris Leaves on Memory, Anxiety, Depression, and Sleep Quality in University Students: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Hashemite University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Hashemite University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Thymus vulgaris could potentially serve as a safer alternative to stimulant drugs for&#xD;
        enhancing memory among university students. Furthermore, Thymus vulgaris may offer additional&#xD;
        benefits in terms of reducing anxiety, depression, and improving sleep quality. However, it&#xD;
        should be noted that the current research on the effects of orally administered Thymus&#xD;
        vulgaris on the brain and nervous system is limited, and further studies are required to&#xD;
        fully explore its potential advantages. Therefore, the purpose of this study is to&#xD;
        investigate the effects of oral Thymus vulgaris on memory performance, anxiety, depression,&#xD;
        and sleep quality in university students.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Thymus vulgaris belongs to the Lamiaceae family and is a flowering plant. It can be found&#xD;
        worldwide, although its origin is in southern Europe [1]. This plant is characterized by its&#xD;
        compact, bushy nature and evergreen shrub structure. Its leaves are small, gray-green, highly&#xD;
        aromatic, and it produces clusters of purple or pink flowers [2]. Thymus vulgaris is commonly&#xD;
        used as a spice to enhance the flavor of food. It is also utilized in the form of dietary&#xD;
        supplements; such as capsules or essential oils [3]. Throughout history, Thymus vulgaris has&#xD;
        been employed in folk medicine due to its remarkable antimicrobial and anti-inflammatory&#xD;
        properties [4]. In Jordanian traditional medicine, it is frequently utilized as an&#xD;
        antiseptic, bronchial, sedative, and spasmolytic agent, as well as to improve cognitive&#xD;
        function and memory [5-8]. Numerous studies have reported various health benefits associated&#xD;
        with Thymus vulgaris leaves, including antioxidant [9], diuretic [10], anti-inflammatory&#xD;
        [11], antiviral [12], anti-cancerous [13], cholesterol-lowering [14], glucose-lowering [15],&#xD;
        anticonvulsant [16], anti-anxiety [17] and sedative-hypnotic activities [18].&#xD;
  &#xD;
        The primary constituents of Thymus vulgaris, notably thymol, p-cymene, γ-terpinene, linalool,&#xD;
        and carvacrol, possess various neuropharmacological properties, including anti-anxiety,&#xD;
        sedative, anticonvulsant, memory-enhancing, and anti-Alzheimer's disease effects [19].&#xD;
        Asadbegi et al. conducted a study demonstrating that thymol exhibited neuroprotective&#xD;
        properties by reducing memory impairment caused by intrahippocampal injection of the amyloid&#xD;
        beta (Aβ) peptide in rats fed a high-fat diet [20]. Furthermore, Capibaride et al. confirmed&#xD;
        the significant antidepressant-like effect of thymol by observing its ability to reverse&#xD;
        behaviors associated with chronic corticosterone exposure and decrease in BDNF levels in&#xD;
        female mice [21]. Azizi et al. demonstrated that carvacrol and thymol exerted neuroprotective&#xD;
        effects against Aβ25-35-induced damage, potentially through the attenuation of oxidative&#xD;
        stress and the modulation of PKC activity, a protein associated with memory function [22].&#xD;
        Additionally, within the monoterpenes and sesquiterpenes, β-myrcene and caryophyllene have&#xD;
        been identified as major compounds. β-myrcene is known for its analgesic, anxiolytic, and&#xD;
        anti-inflammatory effects [23].&#xD;
  &#xD;
        Multiple studies have highlighted the positive impact of Thymus vulgaris on memory, anxiety,&#xD;
        and depression. Akan et al. conducted research on rats using the Morris water maze and found&#xD;
        that Thymus vulgaris L. exhibited beneficial effects against diabetes mellitus-induced&#xD;
        neuropathy and cognitive impairment [24]. They attributed these effects to specific&#xD;
        components like thymol, carvacrol, 8-terpinene, p-cymene, and α-pinene present in high&#xD;
        amounts in the essential oil composition. Similarly, Rabiei et al. suggested that Thymus&#xD;
        vulgaris extract demonstrated anti-amnesic properties in rats with Sco-induced memory&#xD;
        deficits, as assessed by the Morris water maze and passive avoidance tests [25]. The authors&#xD;
        proposed that this effect could be linked to the extract's antioxidant activity or its&#xD;
        influence on the cholinergic system, with carvacrol and thymol playing significant roles&#xD;
        based on their chemical composition. Additionally, an ethanol extract derived from Thymus&#xD;
        vulgaris leaves displayed an anxiolytic profile in rats during the EPM test, unaffected by&#xD;
        locomotor activity [17]. Finally, in the context of Alzheimer's disease, a neurodegenerative&#xD;
        disorder involving cholinergic neuron loss, administration of thyme oil to Caenorhabditis&#xD;
        elegans enhanced neurotransmission by regulating synaptic acetylcholine levels [26].&#xD;
  &#xD;
        The high prevalence of anxiety, depression, and sleep disorders among university students can&#xD;
        significantly affect their memory function [27]. Consequently, an increasing number of&#xD;
        university students have turned to using stimulant drugs to improve their memory performance&#xD;
        and attention, despite the fact that such usage is unauthorized and not intended for&#xD;
        therapeutic purposes [28]. However, the use of these drugs is associated with various side&#xD;
        effects[29,30]. This has led neuroscience researchers to show a growing interest in&#xD;
        identifying cognitive-enhancing drugs that can be safely used by healthy individuals without&#xD;
        any detrimental effects.&#xD;
  &#xD;
        Based on the provided information, it is hypothesized that Thymus vulgaris could potentially&#xD;
        serve as a safer alternative to stimulant drugs for enhancing memory among university&#xD;
        students. Furthermore, Thymus vulgaris may offer additional benefits in terms of reducing&#xD;
        anxiety, depression, and improving sleep quality. However, it should be noted that the&#xD;
        current research on the effects of orally administered Thymus vulgaris on the brain and&#xD;
        nervous system is limited, and further studies are required to fully explore its potential&#xD;
        advantages. Therefore, the purpose of this study is to investigate the effects of oral Thymus&#xD;
        vulgaris on memory performance, anxiety, depression, and sleep quality in university&#xD;
        students.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Actual">December 1, 2022</completion_date>
    <primary_completion_date type="Actual">December 1, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Memory performance</measure>
      <time_frame>30 days</time_frame>
      <description>Prospective and Retrospective Memory Questionnaire (PRMQ) was employed</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anxiety and depression</measure>
      <time_frame>30 days</time_frame>
      <description>Anxiety and depression levels were measured using the Hospital Anxiety and Depression Scale (HADS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep quality</measure>
      <time_frame>30 days</time_frame>
      <description>Pittsburgh Sleep Quality Inventory (PSQI) questionnaire was performed</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">86</enrollment>
    <condition>Memory Dysfunction</condition>
    <condition>Anxiety</condition>
    <condition>Depression</condition>
    <condition>Sleep</condition>
    <arm_group>
      <arm_group_label>Thymus vulgaris group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>500 mg of Thymus vulgaris (capsules) was given orally twice daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>500 mg starch (capsules) was given orally twice daily</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Thymus vulgaris</intervention_name>
      <description>500 mg of Thymus vulgaris (capsules) was given orally twice daily</description>
      <arm_group_label>Thymus vulgaris group</arm_group_label>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Health participants&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  individuals with medical diseases, psychiatric disorders, those using any medications&#xD;
               (including complementary and alternative medicines), as well as pregnant and lactating&#xD;
               individuals, were excluded from participating&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>23 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of Pharmaceutical Sciences</name>
        <address>
          <city>Zarqa</city>
          <zip>13133</zip>
          <country>Jordan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Jordan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Hashemite University</investigator_affiliation>
      <investigator_full_name>Abdelrahim Alqudah</investigator_full_name>
      <investigator_title>Assisstant professor</investigator_title>
    </responsible_party>
    <keyword>Thymus vulgaris leaves</keyword>
    <keyword>Memory performance</keyword>
    <keyword>Anxiety</keyword>
    <keyword>Depression</keyword>
    <keyword>Sleep</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05987228
  org study id: 22/6/2022/2023
  nct id: NCT05987228
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Memory performance
  time frame: 30 days
  description: Prospective and Retrospective Memory Questionnaire (PRMQ) was employed
  measure: Anxiety and depression
  time frame: 30 days
  description: Anxiety and depression levels were measured using the Hospital Anxiety and Depression Scale (HADS)
  measure: Sleep quality
  time frame: 30 days
  description: Pittsburgh Sleep Quality Inventory (PSQI) questionnaire was performed
  arm group label: Thymus vulgaris group
  arm group type: Experimental
  description: 500 mg of Thymus vulgaris (capsules) was given orally twice daily
  arm group label: control group
  arm group type: Placebo Comparator
  description: 500 mg starch (capsules) was given orally twice daily
  intervention type: Dietary Supplement
  intervention name: Thymus vulgaris
  description: 500 mg of Thymus vulgaris (capsules) was given orally twice daily
  arm group label: Thymus vulgaris group
  arm group label: control group
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 23 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Jordan
  responsible party type: Principal Investigator
  investigator affiliation: The Hashemite University
  investigator full name: Abdelrahim Alqudah
  investigator title: Assisstant professor
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Anxiety Disorders