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Completed

NCT Number: NCT05602688

Melissa Officinalis L. Supplementation for Emotional Health and Sleep Disturbance

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ayub Teaching Hospital

Abbottābād, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lemon Balm Supplement

Dietary Supplement

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

Matched Placebo

Dietary Supplement

Matched placebo tablet Twice a day for three-weeks

Primary outcomes

  1. Changes in the level of depression

    Time frame: 3 weeks

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

  2. Changes in the level of anxiety

    Time frame: 3 weeks

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

  3. Changes in the level of stress

    Time frame: 3 weeks

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

  4. Changes in sleep quality

    Time frame: 3 weeks

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

Secondary outcomes

  1. Changes in mental wellbeing

    Time frame: 3 weeks

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

  2. Changes in Positive and Negative Emotional Feelings

    Time frame: 3 weeks

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

  3. Changes in the Quality of Life (QoL)

    Time frame: 3 weeks

    Improvement in the WHO QOL-BREF scale scores

Sponsors and collaborators

Lead sponsor

Ayub Teaching Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2022
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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