Melissa Officinalis L. Supplementation for Emotional Health and Sleep Disturbance

Study Overview
=================
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.

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.

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

Conditions
-----------------
Depression, Anxiety, Stress, Insomnia

Intervention / Treatment
-----------------
* Dietary Supplement: Lemon Balm Supplement
* Dietary Supplement: Matched Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplement Group<br>This arm will receive oral 200 mg Lemon Balm supplement tablet two times a day for three-weeks. | Dietary Supplement: Lemon Balm Supplement<br>* Oral 200 mg Lemon Balm supplement tablet Twice a day for three-weeks<br>|
| Active Comparator: Control group<br>This arm will receive an oral matched placebo tablet two times a day for three-weeks. | Dietary Supplement: Matched Placebo<br>* Matched placebo tablet Twice a day for three-weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mental wellbeing | Improvement in the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score | 3 weeks | 
| Changes in Positive and Negative Emotional Feelings | Improvement in the Positive and Negative Affect Scale (PANAS) score | 3 weeks | 
| Changes in the Quality of Life (QoL) | Improvement in the WHO QOL-BREF scale scores | 3 weeks |