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This study is aimed to investigate if Lemon Balm Extract supplementation is beneficial for the relief of stress, depression and anxiety in healthy adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplement Group | Experimental | This arm will receive oral 200 mg Lemon Balm supplement tablet two times a day for three-weeks. |
|
| Control group | Active Comparator | This arm will receive an oral matched placebo tablet two times a day for three-weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lemon Balm Supplement | Dietary Supplement | Oral 200 mg Lemon Balm supplement tablet Twice a day for three-weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the level of depression | Improvement in the Depression score in the Depression Anxiety and Stress Scale (DASS) | 3 weeks |
| Changes in the level of anxiety | Improvement in the Anxiety score in the Depression Anxiety and Stress Scale (DASS) | 3 weeks |
| Changes in the level of stress | Improvement in the Stress score in the Depression Anxiety and Stress Scale (DASS) | 3 weeks |
| Changes in sleep quality | Improvement in the Pittsburgh Sleep Quality Index (PSQI) scale score | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in mental wellbeing | Improvement in the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score | 3 weeks |
| Changes in Positive and Negative Emotional Feelings | Improvement in the Positive and Negative Affect Scale (PANAS) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ayub Teaching Hospital | Abbottābād | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25680840 | Background | 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. | |
| 32620104 |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| Matched Placebo | Dietary Supplement | Matched placebo tablet Twice a day for three-weeks |
|
| 3 weeks |
| Changes in the Quality of Life (QoL) | Improvement in the WHO QOL-BREF scale scores | 3 weeks |
| 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. |
| 12143909 | Background | 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. |
| Background | Emamghoreishi, M. and M.S. Talebianpour, Antidepressant effect of Melissa officinalis in the forced swimming test. DARU, 2009. 17: p. 42-47 |
| 29908682 | Background | 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. |
| 29369810 | Background | 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. |
| 16444660 | Background | 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. |
| 15272110 | Background | 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. |
| 12062586 | Background | 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. |
| 12888775 | Background | 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. |
| 30591886 | Background | 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. |
| 29741926 | Background | 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. |
| 33465795 | Background | 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. |
| Background | 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 |
| 22207903 | Result | Cases J, Ibarra A, Feuillere N, Roller M, Sukkar SG. Pilot trial of Melissa officinalis L. leaf extract in the treatment of volunteers suffering from mild-to-moderate anxiety disorders and sleep disturbances. Med J Nutrition Metab. 2011 Dec;4(3):211-218. doi: 10.1007/s12349-010-0045-4. Epub 2010 Dec 17. |
| 37927585 | Derived | Bano A, Hepsomali P, Rabbani F, Farooq U, Kanwal A, Saleem A, Bugti AA, Khan AA, Khalid Z, Bugti M, Mureed S, Khan S, Ujjan ID, Sahin S, Kara M, Khan A. The possible "calming effect" of subchronic supplementation of a standardised phospholipid carrier-based Melissa officinalis L. extract in healthy adults with emotional distress and poor sleep conditions: results from a prospective, randomised, double-blinded, placebo-controlled clinical trial. Front Pharmacol. 2023 Oct 19;14:1250560. doi: 10.3389/fphar.2023.1250560. eCollection 2023. |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |