Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202205585377035 Date of Approval: 13/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A randomized controlled pilot of Laurus nobilis Tea on inflammatory biomarkers
Official scientific title The effect of daily Laurus nobilis tea on inflammatory biomarkers: A randomized controlled pilot study in Healthy North-African Volunteers
Brief summary describing the background and objectives of the trial BACKGROUND.Laurus nobilis (Ln) known as bay, sweet bay, bay laurel, Roman laurel or just laurel, among others, is a tree native to the Mediterranean countries. It is an aromatic shrub plant belonging to the Lamiaceae family commonly used to flavor many dishes, particularly among Mediterranean cuisines and in folk medicine since antiquity against rheumatism, cough, cardiac diseases, viral infections, diarrhea, etc., and as a general gastric secretion stimulant, carminative, diaphoretic and antiseptic. Laurus nobilis has been traditionally used for culinary and medical purposes. It is known in the field of herbal medicine and in vitro studies that Ln has beneficial effects such as antibacterial, antifungal, anti-diabetes, antihyperlipidemic, hepato-protective and anti-inflammatory properties. Most of our knowledge about the therapeutic benefits of Ln on human health, comes from the field of herbal medicine and in vitro studies attributing to this plant virtues antibacterial, antifungal, anti-diabetes, antihyperlipidimic and anti-inflammatory properties. Several studies demonstrated that the neutrophil/lymphocyte ratio (NLR) is a potential indicator for determining inflammation in cardiac disorders, cancer, Alzheimer’s disease , major depressive disorder in patients with schizophrenia in a psychotic episode and in patients with bipolar disorder maniac episode . It was also reported that an elevated NLR is an important predictor of chronic stress in multiple species, including humans. OBJECTIVES.The purpose of this randomized, double-blind controlled trial, which will be include two groups [Experimental group (EG), control group (CG)], will be to investigate the effects of Laurus nobilis tea (Lnt) consumption on NLR and various complete blood count elements. The null hypothesis will be that the two groups will have similar NLR values, 10 days after the intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Lnt
Disease(s) or condition(s) being studied Cardiology,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 04/05/2022
Actual trial start date 04/05/2022
Anticipated date of last follow up 31/05/2022
Actual Last follow-up date 31/05/2022
Anticipated target sample size (number of participants) 62
Actual target sample size (number of participants) 50
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Origanum syriacum L 5 grams 10 days The placebo material will be prepared from the hard stems of Origanum syriacum L. Stems will be cleaned and boiled for five hours, with water change every one hour. Prolonged boiling will be performed to make the stems with a very poor content of water-soluble components 25 Placebo
Experimental Group Laurus nobilis tea 5 grams 10 days Five grams of dried Laurus nobilis tea leaves in 100 ml of boiling water for 15 min, and to filter the mixture through a strainer. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
No smoking No vegetarian diet No pregnancy No consumption of medication or nutritional supplements No any anti-inflammatory treatment (non-steroid anti-inflammatory drug, corticosteroid or other anti-inflammatory drug) No chronic pathologies (eg; cardiovascular diseases, diabetes-mellitus, arterial-hypertension, asthma, psychiatric disorders, gastrointestinal problems) No food allergy The absence during the second visit (ie; Day11 of the study) The non-consumption of the Lnt or the placebo tea at least one time Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 28 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/05/2022 Medical Research and Ethical Committee at the Faculty of Medicine of Sousse
Ethics Committee Address
Street address City Postal code Country
Mohamed Karoui street Sousse 4000 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neutrophil/lymphocyte ratio (NLR) 10 days
Secondary Outcome White blood cell count (WBC), neutrophil count, lymphocyte count, platelet and monocyte count analysis 10 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hospital Farhat Hached Street Ibn Eljazzar Sousse 4000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Metabolic Biophysics Applied Pharmacology Laboratory Mohamed Karoui Street Sousse 4000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Metabolic Biophysics Applied Pharmacology Laboratory Mohamed Karoui Street Sousse 4000 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
Chbili Chahra Mohamed Karoui Street Sousse 4000 Tunisia
maoua Maher Mohamed Karoui Street Sousse 4000 Tunisia
Hammami Saoussen BP 56 Environment street Monastir 5019 Tunisia
Simone Angeloni via SantAgostino1 Camerino I-62032 Italy
Giovanni Caprioli via SantAgostino 1 Camerino I-62032 Italy
Filippo Maggi via SantAgostino 1 Camerino I-62032 Italy
Selmi Mejda Mohamed Karoui Sousse 4000 Tunisia
Bessma Bel Hadj Jrad Monastir street Monastir 5019 Tunisia
Mrizek Nejib Mohamed Karoui Sousse 4000 Tunisia
Nouira Manel Mohamed Karoui street Sousse 4000 Tunisia
Khairi Hedi Mohamed Karoui Street Sousse 4000 Tunisia
Ben Fredj Maha1 Mohamed Karoui Street Sousse 4000 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chahra Chbili chahrachbili@yahoo.fr +21693645001 Mohamed Karoui Street
City Postal code Country Position/Affiliation
Sousse 4000 Tunisia Metabolic Biophysics and Applied Pharmacology Laboratory Faculty of Medicine SousseTunisia
Role Name Email Phone Street address
Public Enquiries Chahra Chbili chahrachbili@yahoo.fr +21693645001 Mohamed Karoui Street
City Postal code Country Position/Affiliation
Sousse Tunisia Metabolic Biophysics and Applied Pharmacology Laboratory Faculty of Medicine Sousse Tunisia
Role Name Email Phone Street address
Scientific Enquiries Chahra Chbili chahrachbili@yahoo.fr +21693645001 Mohamed Karoui Street
City Postal code Country Position/Affiliation
Sousse Tunisia Metabolic Biophysics and Applied Pharmacology Laboratory Faculty of Medicine Sousse Tunisia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available and collected during the trial after deidenfication. All of the individual participant data collected during the trial, after deidentification. Study protocol, Informed Consent Form will be available. The data will be available immediately following final publication. Ending 2 years following article publication. The data will be available with researchers who provide a methodologically sound proposition to achieve aims into the proposed proposal. Proposals should be directed to chahrachbili@yahoo.fr Informed Consent Form,Study Protocol 12 months Lnt
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information