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.: PACTR202205801626909 Date of Approval: 12/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pilot Study of Origanum majoranaTea on Oxidant/Antioxidant Stress Biomarkers in Parkinson disorder North-African Volunteers
Official scientific title Randomized, Placebo-Controlled Pilot Study of Origanum majorana Tea on Oxidant/Antioxidant Stress Biomarkers in Parkinson Idiopathic disorder North-African Patients Volunteers
Brief summary describing the background and objectives of the trial BACKGROUND Parkinson’s disease (PD) is the second common chronic neurodegenerative disease after Alzheimer’s disease, characterized by the degeneration of dopaminergic nigro-striatal neurones to the corpus striatum, that induce non-motor and motor symptoms. Many researches incriminated Oxidative changes is one of the important factor contributors in the genesis of Parkinson’s disease. During the pathogenesis of PD, inflammation and oxidative stress play critical roles in the cascade of events leading to loss of dopaminergic neurons in PD. This phenomenon seems to be induced mainly by changes in iron content of the brain, mitochondrial dysfunction, monoamine oxidase (MAO) activation, or even by changes in the antioxidant defense system include superoxide dismutase (SOD), catalase, glutathione, and uric acid (UA). Despite the link between oxidative damage and the progression of PD, to date, the effects obtained with antioxidant therapies are modest. Antioxidant molecules have been considered attractive therapeutic drugs to cure PD. However, no direct antioxidant, such as vitamin C, vitamin E, and coenzyme Q10, has shown significant effects on modification in PD patients. Previous works, reported that several plant extracts are powerful in PD risk. The alternative treatment of PD is the therapy of herbal medicine (HM). The use of natural products due to their safety, efficiency, acceptability and comparably fewer side effects than chemical drugs. They contain active components that could be effective on treatment or delay neurodegeneration progression in PD. From these studies, our hypothesis is to test the effect of Origanum majorana (Om) on antioxidant fractions levels and the possibility to slower PD progression. In the other hand, in the present work we assessed the potential protective role of Origanum majorana through the stimulation of the antioxidant system in order to reduce and improve symptoms related to Parkinson's disease. Origanum majorana L an evergreen tree of Lamiaceae family known by the name’s sweet marjoram or marjoram. Origanum majorana has several therapeutic properties. It is known to have a beneficial effect as an infusion of the fresh herb in treating cramps, depression, dizziness, upset stomach, indigestion, gastrointestinal disorders, colic, migraine, nervous complaints, paroxysmal coughs and as a diuretic. To the best of our knowledge, there is no scientific data that highlights the therapeutic effects of Origanum majorana infusion on PD patients in particular its impact on the increased anti-oxidant activity in blood plasma. OBJECTIVES. The purpose of this randomized, double-blind controlled trial, which includes two groups [Experimental group (EG), control group (CG)], was to investigate the effect of Origanum majorana tea consumption on oxidant/antioxidant data in humans. The null hypothesis was that the two groups will have similar SOD values, 30 days after the intervention. The primary outcome of this exploratory investigation was to identify SOD biomarker that would be affected by Origanum majorana tea consumption. This is to reduce or delay the propagation of disease and the secondary were Catalase, CP: Carbonylated proteins and UA: Uric acid analysis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Omt
Disease(s) or condition(s) being studied Nervous System Diseases,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 09/05/2022
Actual trial start date 09/05/2022
Anticipated date of last follow up 01/07/2022
Actual Last follow-up date 01/06/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 55
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
Experimental Group Experimental Group 5 grams 30 days Five grams of dried Origanum majorana tea leaves in 100 ml of boiling water for 15 min. 30
Control Group Control group 5 grams 30 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 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
.Age of 40–80 years old .Diagnosis of PD MDS criteria 2015 .Hoehn and Yahr stage less than 4 .Treatment with dose and regimen unchanged for at least 12 weeks prior to screening .No nutritional supplements intake The absence during the second visit (ie; Day31 of the study) The non-consumption of the Omt or the placebo tea at least one time. Patients had a history of cardiovascular disease, diabetes, renal dysfunction, asthma, food allergies, liver or major gastrointestinal problems or hypertension. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 26 Year(s) 88 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 09/05/2022 Medical Research and Ethical Committee at the Faculty of Medicine of Sousse
Ethics Committee Address
Street address City Postal code Country
Street Mohamed KAROUI Sousse 4000 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome SOD 30 days
Secondary Outcome Catalase ,Carbonylated proteins and Uric acid 30 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hospital Sahloul Sahloul Belt Road Sousse 4011 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Metabolic Biophysics Applied Pharmacology research Laboratory Mohamed Karoui 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
Mrad Sawssen Mohamed Karoui street Sousse 4000 Tunisia
Hassine Anis Mohamed Karoui street Sousse 4000 Tunisia
Selmi Mejda Mohamed Karoui street Sousse 4000 Tunisia
Ben Abdallah Jihene Mohamed Karoui street Sousse 4000 Tunisia
Maatoug Jihen Mohamed Karoui street Sousse 4000 Tunisia
Naija Salma Mohamed Karoui street Sousse 4000 Tunisia
Nouira Manel Mohamed Karoui street Sousse 4000 Tunisia
Ben Amor Sana Mohamed Karoui street Sousse 4000 Tunisia
Khairi Hedi Mohamed Karoui street Sousse 4000 Tunisia
Ben Fredj Maha 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 Applied Pharmacology Laboratory
Role Name Email Phone Street address
Scientific Enquiries Sana Ben Amor kaffelsana@yahoo.fr +21673222108 Mohamed Karoui Street
City Postal code Country Position/Affiliation
Sousse Tunisia Neurology Department Sahloul Teaching Hospital
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 Applied Pharmacology Laboratory
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 Origanum majorana
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