Melissa Officinalis L. Supplementation for Emotional Health and Sleep Disturbance

Ayub Teaching Hospital

Status: Completed

Conditions: Insomnia; Depression; Anxiety; Stress

Treatments: Dietary Supplement: Matched Placebo; Dietary Supplement: Lemon Balm Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05602688

RC-2022/EA-01/194

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

102 participants in 2 patient groups

Supplement Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lemon Balm Supplement

Control group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Matched Placebo