Melissa Officinalis L. Supplementation for Emotional Health and Sleep Disturbance

May 29, 2023 updated by: Ayub Teaching Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Abbottābād, Pakistan
        • Ayub Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the level of depression
Time Frame: 3 weeks
Improvement in the Depression score in the Depression Anxiety and Stress Scale (DASS)
3 weeks
Changes in the level of anxiety
Time Frame: 3 weeks
Improvement in the Anxiety score in the Depression Anxiety and Stress Scale (DASS)
3 weeks
Changes in the level of stress
Time Frame: 3 weeks
Improvement in the Stress score in the Depression Anxiety and Stress Scale (DASS)
3 weeks
Changes in sleep quality
Time Frame: 3 weeks
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
Time Frame: 3 weeks
Improvement in the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) score
3 weeks
Changes in Positive and Negative Emotional Feelings
Time Frame: 3 weeks
Improvement in the Positive and Negative Affect Scale (PANAS) score
3 weeks
Changes in the Quality of Life (QoL)
Time Frame: 3 weeks
Improvement in the WHO QOL-BREF scale scores
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ayub Teaching Hospital

Collaborators

Ayub Medical College, Abbottabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2023

Primary Completion (Actual)

April 10, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

October 27, 2022

First Submitted That Met QC Criteria

October 27, 2022

First Posted (Actual)

November 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-2022/EA-01/194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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