Melissa Officinalis L. Supplementation for Emotional Health and Sleep Disturbance

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05602688
• Other study ID #: RC-2022/EA-01/194
• Status: Completed
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: Ayub Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 30, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Dyssomnias
• Insomnia
• Parasomnias
• Stress

Intervention

Dietary Supplement:
• Lemon Balm Supplement
Oral 200 mg Lemon Balm supplement tablet Twice a day for three-weeks
• Matched Placebo
Matched placebo tablet Twice a day for three-weeks

Locations

Country	Name	City	State
Pakistan	Ayub Teaching Hospital	Abbottabad

Sponsors (1)

Lead Sponsor	Collaborator
Ayub Teaching Hospital

Country where clinical trial is conducted

Pakistan, 

References & Publications (15)

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. — View 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. — View 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. — View Citation

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. — View Citation

Emamghoreishi, M. and M.S. Talebianpour, Antidepressant effect of Melissa officinalis in the forced swimming test. DARU, 2009. 17: p. 42-47

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the level of depression	Improvement in the Depression score in the Depression Anxiety and Stress Scale (DASS)	3 weeks
Primary	Changes in the level of anxiety	Improvement in the Anxiety score in the Depression Anxiety and Stress Scale (DASS)	3 weeks
Primary	Changes in the level of stress	Improvement in the Stress score in the Depression Anxiety and Stress Scale (DASS)	3 weeks
Primary	Changes in sleep quality	Improvement in the Pittsburgh Sleep Quality Index (PSQI) scale score	3 weeks
Secondary	Changes in mental wellbeing	Improvement in the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score	3 weeks
Secondary	Changes in Positive and Negative Emotional Feelings	Improvement in the Positive and Negative Affect Scale (PANAS) score	3 weeks
Secondary	Changes in the Quality of Life (QoL)	Improvement in the WHO QOL-BREF scale scores	3 weeks