Melissa Officinalis L. Supplementation for Emotional Health and Sleep Disturbance

NCT05602688 | Completed DMC

• 1 other identifier: RC-2022/EA-01/194
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Stress; Insomnia

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• Changes in mental wellbeing

  3 weeks

• Changes in Positive and Negative Emotional Feelings

  3 weeks

• Changes in the Quality of Life (QoL)

  3 weeks

Study Arms (2)

Supplement Group

EXPERIMENTAL

This arm will receive oral 200 mg Lemon Balm supplement tablet two times a day for three-weeks.

Dietary Supplement: Lemon Balm Supplement

Control group

ACTIVE COMPARATOR

This arm will receive an oral matched placebo tablet two times a day for three-weeks.

Dietary Supplement: Matched Placebo

Interventions

Lemon Balm Supplement DIETARY_SUPPLEMENT

Oral 200 mg Lemon Balm supplement tablet Twice a day for three-weeks

Supplement Group

Matched Placebo DIETARY_SUPPLEMENT

Matched placebo tablet Twice a day for three-weeks

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ayub Teaching Hospital: lead

Study Sites (1)

Ayub Teaching Hospital

Abbottābād, Pakistan

Location

Related Publications (16)

• 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.

  PMID: 25680840 BACKGROUND

• 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.

  PMID: 32620104 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.

  PMID: 12143909 BACKGROUND

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

  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.

  PMID: 29908682 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.

  PMID: 29369810 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.

  PMID: 16444660 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.

  PMID: 15272110 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.

  PMID: 12062586 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.

  PMID: 12888775 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.

  PMID: 30591886 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.

  PMID: 29741926 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.

  PMID: 33465795 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

  BACKGROUND

• 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.

  PMID: 22207903 RESULT

• 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.

  PMID: 37927585 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 2, 2022
• Study Start: January 3, 2023
• Primary Completion: April 10, 2023
• Study Completion: April 30, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)