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AzTrials

DepressionNCT05602688

Melissa Officinalis L. Supplementation for Emotional Health and Sleep Disturbance

A study testing Lemon Balm Supplement in people with Depression and Anxiety, run by Ayub Teaching Hospital at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Depression, Anxiety, Stress
What is being tested?
Lemon Balm Supplement
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
1 sitePakistan
Study dates
3 Jan 2023to 30 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Ayub Teaching Hospital

    Abbottābād

Other trials in Pakistan

About this study

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

This study is aimed to investigate if Lemon Balm Extract supplementation is beneficial for the relief of stress, depression and anxiety in healthy adults.

Read the 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.

Being tested
Lemon Balm Supplement, Matched Placebo
Medical subject headings
Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lemon Balm SupplementDietary supplement

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

  • Matched PlaceboDietary supplement

    Matched placebo tablet Twice a day for three-weeks

Study groups in NCT05602688
Study groupRoleWhat they receive
Supplement GroupExperimentalThis arm will receive oral 200 mg Lemon Balm supplement tablet two times a day for three-weeks.
Receives: Dietary Supplement: Lemon Balm Supplement
Control groupActive comparatorThis arm will receive an oral matched placebo tablet two times a day for three-weeks.
Receives: Dietary Supplement: Matched Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the level of depression

    Improvement in the Depression score in the Depression Anxiety and Stress Scale (DASS)

    Measured: 3 weeks

  2. Changes in the level of anxiety

    Improvement in the Anxiety score in the Depression Anxiety and Stress Scale (DASS)

    Measured: 3 weeks

  3. Changes in the level of stress

    Improvement in the Stress score in the Depression Anxiety and Stress Scale (DASS)

    Measured: 3 weeks

  4. Changes in sleep quality

    Improvement in the Pittsburgh Sleep Quality Index (PSQI) scale score

    Measured: 3 weeks

Secondary outcomes (3)

  1. Changes in mental wellbeing

    Improvement in the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score

    Measured: 3 weeks

  2. Changes in Positive and Negative Emotional Feelings

    Improvement in the Positive and Negative Affect Scale (PANAS) score

    Measured: 3 weeks

  3. Changes in the Quality of Life (QoL)

    Improvement in the WHO QOL-BREF scale scores

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2022
  2. Study start3 Jan 2023
  3. Primary completion10 Apr 2023
  4. Study completion30 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05602688
Sponsor's protocol ID
RC-2022/EA-01/194
Status last verified
May 2023
First submitted
27 Oct 2022
Last updated
31 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25680840

  • 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.

    PubMed 32620104

  • 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.

    PubMed 12143909

  • 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.

    PubMed 29908682

  • 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.

    PubMed 29369810

  • 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.

    PubMed 16444660

  • 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.

    PubMed 15272110

  • 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.

    PubMed 12062586

  • 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.

    PubMed 12888775

  • 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.

    PubMed 30591886

  • 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.

    PubMed 29741926

  • 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.

    PubMed 33465795

  • 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

  • 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.

    PubMed 22207903

Questions about this trial

What is this clinical trial studying?

A study testing Lemon Balm Supplement in people with Depression and Anxiety, run by Ayub Teaching Hospital at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the level of depression (time frame: 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05602688, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.

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