Back to resultsMelissa Officinalis L. Supplementation for Emotional Health and Sleep Disturbance
Primary Purpose
Depression, Anxiety, Stress
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Lemon Balm Supplement
Matched Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Depression
Eligibility Criteria
Inclusion Criteria: Healthy individuals, aged 18 - 65 years Individuals suffering from moderate degree of depression, anxiety, and stress with DASS scores ≥14, ≥10, and ≥19, respectively, or individual with sleep problems with Pittsburgh Sleep Quality Index (PSQI) score ≥5. Willing to participate in the study Exclusion Criteria: Current use of prescribed medication or supplements for neuropsychiatric and sleep disorders Known history of neuropsychiatric or sleep disorders Current use or history of illicit substances misuse History of any allergic reactions to ingredients of the Lemon Balm Extract Hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90, or other cardiovascular disease Hyperthyroidism or Diabetes mellitus or cancer Use of blood thinners like Coumadin (warfarin) or Plavix (clopidogrel), Glaucoma medications like Travatan (travoprost), Chemotherapy drugs like tamoxifen and Camptosar (irinotecan) Severe medical problem, which in the opinion of the investigator would pose a safety risk to the subject
Sites / Locations
- Ayub Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Supplement Group
Control group
Arm Description
This arm will receive oral 200 mg Lemon Balm supplement tablet two times a day for three-weeks.
This arm will receive an oral matched placebo tablet two times a day for three-weeks.
Outcomes
Primary Outcome Measures
Changes in the level of depression
Improvement in the Depression score in the Depression Anxiety and Stress Scale (DASS)
Changes in the level of anxiety
Improvement in the Anxiety score in the Depression Anxiety and Stress Scale (DASS)
Changes in the level of stress
Improvement in the Stress score in the Depression Anxiety and Stress Scale (DASS)
Changes in sleep quality
Improvement in the Pittsburgh Sleep Quality Index (PSQI) scale score
Secondary Outcome Measures
Changes in mental wellbeing
Improvement in the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score
Changes in Positive and Negative Emotional Feelings
Improvement in the Positive and Negative Affect Scale (PANAS) score
Changes in the Quality of Life (QoL)
Improvement in the WHO QOL-BREF scale scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05602688
Brief Title
Melissa Officinalis L. Supplementation for Emotional Health and Sleep Disturbance
Official Title
Study to Investigate Melissa Officinalis L. Supplementation for Emotional Health and Sleep Disturbance: A Perspective, Randomized, Double-blinded, Placebo-controlled, Parallel-group Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
April 10, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ayub Teaching Hospital
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
This study is aimed to investigate if Lemon Balm Extract supplementation is beneficial for the relief of stress, depression and anxiety in healthy adults.
Detailed Description
Lemon balm (Botanical name: Melissa officinalis L.) is a herbal plant belongs to the Lamiaceae (mint) family, and currently of wide scientific interest as possible adjuvant for calming effect. Lemon balm is one of the most popular and widely used medicinal herbs in central and southern Europe, the Mediterranean region, and west Asia. The European Scientific Cooperative on Phytotherapy (ESCOP) recommends the use of lemon balm to relieve of mild symptoms of anxiety, including mental stress, restlessness, and irritability. Historically, Lemon balm has been widely used in Asian traditional medicine as a sedative to treat many psychiatric disorders, such as stress, depression, anxiety, and insomnia. Lemon balm has shown anti-depressant, anxiolytic, and anti-insomnia effects both in human clinical trials and in animal model studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Stress, Insomnia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supplement Group
Arm Type
Experimental
Arm Description
This arm will receive oral 200 mg Lemon Balm supplement tablet two times a day for three-weeks.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
This arm will receive an oral matched placebo tablet two times a day for three-weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lemon Balm Supplement
Intervention Description
Oral 200 mg Lemon Balm supplement tablet Twice a day for three-weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Matched Placebo
Intervention Description
Matched placebo tablet Twice a day for three-weeks
Primary Outcome Measure Information:
Title
Changes in the level of depression
Description
Improvement in the Depression score in the Depression Anxiety and Stress Scale (DASS)
Time Frame
3 weeks
Title
Changes in the level of anxiety
Description
Improvement in the Anxiety score in the Depression Anxiety and Stress Scale (DASS)
Time Frame
3 weeks
Title
Changes in the level of stress
Description
Improvement in the Stress score in the Depression Anxiety and Stress Scale (DASS)
Time Frame
3 weeks
Title
Changes in sleep quality
Description
Improvement in the Pittsburgh Sleep Quality Index (PSQI) scale score
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Changes in mental wellbeing
Description
Improvement in the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score
Time Frame
3 weeks
Title
Changes in Positive and Negative Emotional Feelings
Description
Improvement in the Positive and Negative Affect Scale (PANAS) score
Time Frame
3 weeks
Title
Changes in the Quality of Life (QoL)
Description
Improvement in the WHO QOL-BREF scale scores
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy individuals, aged 18 - 65 years
Individuals suffering from moderate degree of depression, anxiety, and stress with DASS scores ≥14, ≥10, and ≥19, respectively, or individual with sleep problems with Pittsburgh Sleep Quality Index (PSQI) score ≥5.
Willing to participate in the study
Exclusion Criteria:
Current use of prescribed medication or supplements for neuropsychiatric and sleep disorders
Known history of neuropsychiatric or sleep disorders
Current use or history of illicit substances misuse
History of any allergic reactions to ingredients of the Lemon Balm Extract
Hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90, or other cardiovascular disease
Hyperthyroidism or Diabetes mellitus or cancer
Use of blood thinners like Coumadin (warfarin) or Plavix (clopidogrel), Glaucoma medications like Travatan (travoprost), Chemotherapy drugs like tamoxifen and Camptosar (irinotecan)
Severe medical problem, which in the opinion of the investigator would pose a safety risk to the subject
Facility Information:
Facility Name
Ayub Teaching Hospital
City
Abbottābād
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25680840
Citation
Alijaniha F, Naseri M, Afsharypuor S, Fallahi F, Noorbala A, Mosaddegh M, Faghihzadeh S, Sadrai S. Heart palpitation relief with Melissa officinalis leaf extract: double blind, randomized, placebo controlled trial of efficacy and safety. J Ethnopharmacol. 2015 Apr 22;164:378-84. doi: 10.1016/j.jep.2015.02.007. Epub 2015 Feb 11.
Results Reference
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PubMed Identifier
32620104
Citation
Araj-Khodaei M, Noorbala AA, Yarani R, Emadi F, Emaratkar E, Faghihzadeh S, Parsian Z, Alijaniha F, Kamalinejad M, Naseri M. A double-blind, randomized pilot study for comparison of Melissa officinalis L. and Lavandula angustifolia Mill. with Fluoxetine for the treatment of depression. BMC Complement Med Ther. 2020 Jul 3;20(1):207. doi: 10.1186/s12906-020-03003-5.
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PubMed Identifier
12143909
Citation
Ballard CG, O'Brien JT, Reichelt K, Perry EK. Aromatherapy as a safe and effective treatment for the management of agitation in severe dementia: the results of a double-blind, placebo-controlled trial with Melissa. J Clin Psychiatry. 2002 Jul;63(7):553-8. doi: 10.4088/jcp.v63n0703.
Results Reference
background
Citation
Emamghoreishi, M. and M.S. Talebianpour, Antidepressant effect of Melissa officinalis in the forced swimming test. DARU, 2009. 17: p. 42-47
Results Reference
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PubMed Identifier
29908682
Citation
Haybar H, Javid AZ, Haghighizadeh MH, Valizadeh E, Mohaghegh SM, Mohammadzadeh A. The effects of Melissa officinalis supplementation on depression, anxiety, stress, and sleep disorder in patients with chronic stable angina. Clin Nutr ESPEN. 2018 Aug;26:47-52. doi: 10.1016/j.clnesp.2018.04.015. Epub 2018 May 19.
Results Reference
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PubMed Identifier
29369810
Citation
Heydari N, Dehghani M, Emamghoreishi M, Akbarzadeh M. Effect of Melissa officinalis capsule on the mental health of female adolescents with premenstrual syndrome: a clinical trial study. Int J Adolesc Med Health. 2018 Jan 25;31(3):/j/ijamh.2019.31.issue-3/ijamh-2017-0015/ijamh-2017-0015.xml. doi: 10.1515/ijamh-2017-0015.
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PubMed Identifier
16444660
Citation
Kennedy DO, Little W, Haskell CF, Scholey AB. Anxiolytic effects of a combination of Melissa officinalis and Valeriana officinalis during laboratory induced stress. Phytother Res. 2006 Feb;20(2):96-102. doi: 10.1002/ptr.1787.
Results Reference
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PubMed Identifier
15272110
Citation
Kennedy DO, Little W, Scholey AB. Attenuation of laboratory-induced stress in humans after acute administration of Melissa officinalis (Lemon Balm). Psychosom Med. 2004 Jul-Aug;66(4):607-13. doi: 10.1097/01.psy.0000132877.72833.71.
Results Reference
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PubMed Identifier
12062586
Citation
Kennedy DO, Scholey AB, Tildesley NT, Perry EK, Wesnes KA. Modulation of mood and cognitive performance following acute administration of Melissa officinalis (lemon balm). Pharmacol Biochem Behav. 2002 Jul;72(4):953-64. doi: 10.1016/s0091-3057(02)00777-3.
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PubMed Identifier
12888775
Citation
Kennedy DO, Wake G, Savelev S, Tildesley NT, Perry EK, Wesnes KA, Scholey AB. Modulation of mood and cognitive performance following acute administration of single doses of Melissa officinalis (Lemon balm) with human CNS nicotinic and muscarinic receptor-binding properties. Neuropsychopharmacology. 2003 Oct;28(10):1871-81. doi: 10.1038/sj.npp.1300230.
Results Reference
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PubMed Identifier
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Citation
Ranjbar M, Firoozabadi A, Salehi A, Ghorbanifar Z, Zarshenas MM, Sadeghniiat-Haghighi K, Rezaeizadeh H. Effects of Herbal combination (Melissa officinalis L. and Nepeta menthoides Boiss. & Buhse) on insomnia severity, anxiety and depression in insomniacs: Randomized placebo controlled trial. Integr Med Res. 2018 Dec;7(4):328-332. doi: 10.1016/j.imr.2018.08.001. Epub 2018 Aug 10.
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PubMed Identifier
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Citation
Ranjbar M, Salehi A, Rezaeizadeh H, Zarshenas MM, Sadeghniiat-Haghighi K, Mirabzadeh M, Firoozabadi A. Efficacy of a Combination of Melissa officinalis L. and Nepeta Menthoides Boiss. & Buhse on Insomnia: A Triple-Blind, Randomized Placebo-Controlled Clinical Trial. J Altern Complement Med. 2018 May 9. doi: 10.1089/acm.2017.0153. Online ahead of print.
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PubMed Identifier
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Citation
Shirazi M, Jalalian MN, Abed M, Ghaemi M. The Effectiveness of Melissa Officinalis L. versus Citalopram on Quality of Life of Menopausal Women with Sleep Disorder: A Randomized Double-Blind Clinical Trial. Rev Bras Ginecol Obstet. 2021 Feb;43(2):126-130. doi: 10.1055/s-0040-1721857. Epub 2021 Jan 19.
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Citation
Soltanpour, A., et al., Effects of Melissa officinalis on anxiety and sleep quality in patients undergoing coronary artery bypass surgery: A double-blind randomized placebo controlled trial. European Journal of Integrative Medicine, 2019. 28: p. 27-32
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Citation
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Results Reference
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Melissa Officinalis L. Supplementation for Emotional Health and Sleep Disturbance
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