OverweightNCT05824039
Safety and Efficacy of Medicinal Plant Extract in Overweight and Obese Participants.
A study testing Tea infusion in people with Overweight and Obesity, run by Laouani Aicha at 1 site in Tunisia.
Trial summary
The purpose of this randomized , double -blind clinical trial is to evaluate the efficacy and safety of a daily administration of Nitraria retusa extract in overweight and obese participants, during 10 days. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Tea infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTunisia
- Study dates
- 20 Mar 2021to 8 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females
- age range of 18 and 75 years
- BMI >25 kg/ m^2
Who cannot join
- Hypertension
- Diabetes
- Asthma
- Smoking
- Professional athletic
- Pregnancy and breast feeding
Show all 11Show fewer
- Participant with medical or psychiatric disorder or chronic pathology,
- Participant with eating disorder, food allergies.
- Participant with a history of cardiovascular disease,
- Participant with medication known to affect lipid metabolism,
- Participant with major gastrointestinal problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of the Short Daily Administration of Nitraria Retusa Extract in Overweight and Obese Participants. .
The purpose of this randomized , double -blind clinical trial is to evaluate the efficacy and safety of a daily administration of Nitraria retusa extract in overweight and obese participants, during 10 days.
Read the detailed description
Medicinal plants are widely used for their accessibility, safety and effectiveness and may be an excellent alternative strategy for developing future drugs with minor adverse effects. Several studies concerning the potential of bioactive components in plants and food products and their link to many diseases including, diabetes, cardiovascular disease and obesity.
Nitraria retusa is a salt-tolerant plant that belongs to the Nitrariaceae family. It is particularly distributed in Asia, China, North Africa, Russia and Europe.It grows in the southern part of Tunisia and it is locally known as Ghardaq. The leaves serve as supplement for the tea and are used as poultice. Fresh leaves of Nitraria retusa have been used in traditional medicine in case of poisoning, upset stomach, ulcers, gastritis, enteritis, heartburn, colitis, and colonic abdominal pain.
Moreover, anticancer, antioxidant, antiviral and antimicrobial activities of N. retusa have been reported .Several reports evinced that the leaf of Nitraria retusa contains high amounts of tannins, alkaloids, steroids and flavonoids, which could be responsible for its beneficial effects . Previous studies have demonstrated the effect of Nitraria retusa extract in obese mice against high fat diet through lowering glucose and triglycerides and the enhancement of the lipid metabolism in liver.
The purpose of this study was to evaluate the efficacy and safety of short daily administration of Nitraria retusa extract in lipid profile in overweight and obese patients, during 10 days.
This study will be carried out in 2 departments: the laboratory of biophysics of the Faculty of Medicine of Sousse and Endocrinology and diabetology of CHU Farhat Hached Sousse ,Tunisia. At day 0 and day 10 all the population will benifit of biological assessment which include:
- Biochimical parameters
- Complete lipid profile (Total Cholesterol (T-C), High-density Lipoprotein (HDL) Low-density Lipoprotein (LDL) and Triglycerides( TG) .
- Blood sugar
- Liver Function Test : Alkaline phosphatase (ALP), gamma-glutamyltransferase (G-GT), albumin, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total ( TB) and direct bilirubin (DB).
- Renal Function Test : Serum Creatinine, urea
- Inflammatory assessment: Reactive protein C
- Hematological parameters : (Red blood cells (RBC), White blood cell (WBC), Platelet, Hemoglobin and Hematocrit).
All Population will be randomized :Participant will be assigned to one of two treatments (low dose flavonoids or high dose flavonoids ). The diatry supplement :Nitraria retusa infusion will be prescribed at a quantity of powder which contained 5 mg of flavonoids or which contained 20 mg of flavonoids , added to 100 ml of boiling water and will be taken once a day at a bed time for 10 consecutive days.
Statistical analysis Data entry and analysis will be performed using SPSS 22.0 for Windows(IBM Corp., NY, USA ). Results will be considered significant at p < 0.05 Normal distributions of the data will be assessed by Shapiro-Wilk test. Within-group differences in the biological parameters before and after the intervention will be compared using paired t-test when data are normally distributed and Wilcoxon Signed Rank Test when data are not normaly distrubuted. Between-group differences (low dose vs high dose) in the parameters will be assessed by independent samples t-test (parametric and equal variances), Welch's t-test (unequal variances) and Mann-Whitney U test (nonparametric)
- Conditions
- Overweight, Obesity
- Being tested
- Tea infusion
- Keywords
- Medicinal plants, Anti-lipidimic agents, Infusion
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tea infusionDietary supplement
Tea infusion: The aerial parts of the medicinal plant were dried, then, they were powdered in a rotating knife grinder. The herbs were taken as tea infusion by the oral route. The powder was added to 100 ml of boiling water and the tea infusion was taken once time a day at the bed time and it was repeated for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1: low dose group | Experimental | Tea infusion which contain 5 mg of flavonoids, (low dose of flavonoids treatment quantification) oral administration , once daily. Receives: Dietary Supplement: Tea infusion |
| Experimental 2 : high dose group | Experimental | Tea infusion which contain 20 mg of flavonoids, ( high dose of flavonoids Treatment quantification) oral administration , once daily . Receives: Dietary Supplement: Tea infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum Triglycerides (TG) levels
To evaluate the efficacy of 20 mg of flavonoids in reducing serum TG compared with low dose group ( 5 mg of flavonoids) after 10 days administration .
Measured: 10 days
Change in serum High Density Lipoprotein Cholesterol (HDL-C) levels
To evaluate the efficacy of 20 mg of flavonoids in increasing HDL-C levels compared with low dose group ( 5 mg of flavonoids) after 10 days administration
Measured: 10 days
Change in Total Cholesterol ( TC) levels
To evaluate the efficacy of 20 mg of flavonoids in reducing TC levels compared with low dose group ( 5 mg of flavonoids) after 10 days administration.
Measured: 10 days
Change in Low Density Lipoprotein Cholesterol (LDL-C) levels
To evaluate the efficacy of 20 mg of flavonoids in reducing LDL-C levels compared with low dose group ( 5 mg of flavonoids) after 10 days administration
Measured: 10 days
Secondary outcomes (17)
no change from baseline in Alkaline phosphatase levels
Measured: 10 days
no change from baseline in Aspartate aminotransferase levels.
Measured: 10 days
no change from baseline in Alanine aminotransferase levels.
Measured: 10 days
no change from baseline in gamma-glutamyltransferase levels.
Measured: 10 days
no change from baseline in Albumin levels .
Measured: 10 days
no change from baseline in total bilirubin levels
Measured: 10 days
no change from baseline in direct bilirubin levels
Measured: 10 days
no change from baseline in urea levels
Measured: 10 days
no change from baseline in creatinine levels
Measured: 10 days
no change from baseline in fasting blood glucose levels
Measured: 10 days
no change from baseline in Red blood cells levels
Measured: 10 days
no change from baseline in White blood cells levels
Measured: 10 days
no change from baseline in Hemoglobin levels
Measured: 10 days
no change from baseline in Hematocrit levels
Measured: 10 days
no change from baseline in Platelets levels
Measured: 10 days
no change from baseline in Hemodynamic indicators: heart rate and blood pressure : systolic blood pressure and diastolic blood pressure
Measured: 10 days
Adverse events
Adverse events reported
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start20 Mar 2021
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laouani Aicha
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty of Medicine, Sousse, Centre Hôpital Universitaire Farhat Hached, Université de Sousse, University of Tsukuba
- Responsible party
- Sponsor-investigator, Laouani Aicha, Faculty of Medicine, Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824039
- Sponsor's protocol ID
- CEFMS 34/2019
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boubaker J, Bhouri W, Ben Sghaier M, Ghedira K, Dijoux Franca MG, Chekir-Ghedira L. Ethyl acetate extract and its major constituent, isorhamnetin 3-O-rutinoside, from Nitraria retusa leaves, promote apoptosis of human myelogenous erythroleukaemia cells. Cell Prolif. 2011 Oct;44(5):453-61. doi: 10.1111/j.1365-2184.2011.00772.x.
PubMed 21951288Boubaker J, Bhouri W, Sghaier MB, Bouhlel I, Skandrani I, Ghedira K, Chekir-Ghedira L. Leaf extracts from Nitraria retusa promote cell population growth of human cancer cells by inducing apoptosis. Cancer Cell Int. 2011 Oct 31;11(1):37. doi: 10.1186/1475-2867-11-37.
PubMed 22040460Chaabane M, Koubaa M, Soudani N, Elwej A, Grati M, Jamoussi K, Boudawara T, Ellouze Chaabouni S, Zeghal N. Nitraria retusa fruit prevents penconazole-induced kidney injury in adult rats through modulation of oxidative stress and histopathological changes. Pharm Biol. 2017 Dec;55(1):1061-1073. doi: 10.1080/13880209.2016.1278455.
PubMed 28198206Hashempur MH, Mosavat SH, Heydari M, Shams M. Medicinal plants' use among patients with dyslipidemia: an Iranian cross-sectional survey. J Complement Integr Med. 2018 Nov 3;16(3):/j/jcim.2019.16.issue-3/jcim-2018-0101/jcim-2018-0101.xml. doi: 10.1515/jcim-2018-0101.
PubMed 30391934Zar Kalai F, Han J, Ksouri R, Abdelly C, Isoda H. Oral administration of Nitraria retusa ethanolic extract enhances hepatic lipid metabolism in db/db mice model 'BKS.Cg-Dock7(m)+/+ Lepr(db/)J' through the modulation of lipogenesis-lipolysis balance. Food Chem Toxicol. 2014 Oct;72:247-56. doi: 10.1016/j.fct.2014.07.029. Epub 2014 Jul 30.
PubMed 25086370Rjeibi I, Feriani A, Hentati F, Hfaiedh N, Michaud P, Pierre G. Structural characterization of water-soluble polysaccharides from Nitraria retusa fruits and their antioxidant and hypolipidemic activities. Int J Biol Macromol. 2019 May 15;129:422-432. doi: 10.1016/j.ijbiomac.2019.02.049. Epub 2019 Feb 8.
PubMed 30742925Zar Kalai F, Han J, Ksouri R, El Omri A, Abdelly C, Isoda H. Antiobesity Effects of an Edible Halophyte Nitraria retusa Forssk in 3T3-L1 Preadipocyte Differentiation and in C57B6J/L Mice Fed a High Fat Diet-Induced Obesity. Evid Based Complement Alternat Med. 2013;2013:368658. doi: 10.1155/2013/368658. Epub 2013 Dec 3.
PubMed 24367387
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Short Daily Administration of Nitraria Retusa Extract in Overweight and Obese Participants. .
- ClinicalTrials.gov ID
- NCT05824039
- Acronym / sponsor ID
- CEFMS 34/2019
- Conditions
- Overweight, Obesity
- Keywords
- Medicinal plants, Anti-lipidimic agents, Infusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Laouani AichaUniversity, hospital or other
- Collaborators
- Faculty of Medicine, Sousse, Centre Hôpital Universitaire Farhat Hached, Université de Sousse, University of Tsukuba
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized , double -blind clinical trial is to evaluate the efficacy and safety of a daily administration of Nitraria retusa extract in overweight and obese participants, during 10 days.
Detailed description
Medicinal plants are widely used for their accessibility, safety and effectiveness and may be an excellent alternative strategy for developing future drugs with minor adverse effects. Several studies concerning the potential of bioactive components in plants and food products and their link to many diseases including, diabetes, cardiovascular disease and obesity.
Nitraria retusa is a salt-tolerant plant that belongs to the Nitrariaceae family. It is particularly distributed in Asia, China, North Africa, Russia and Europe.It grows in the southern part of Tunisia and it is locally known as Ghardaq. The leaves serve as supplement for the tea and are used as poultice. Fresh leaves of Nitraria retusa have been used in traditional medicine in case of poisoning, upset stomach, ulcers, gastritis, enteritis, heartburn, colitis, and colonic abdominal pain.
Moreover, anticancer, antioxidant, antiviral and antimicrobial activities of N. retusa have been reported .Several reports evinced that the leaf of Nitraria retusa contains high amounts of tannins, alkaloids, steroids and flavonoids, which could be responsible for its beneficial effects . Previous studies have demonstrated the effect of Nitraria retusa extract in obese mice against high fat diet through lowering glucose and triglycerides and the enhancement of the lipid metabolism in liver.
The purpose of this study was to evaluate the efficacy and safety of short daily administration of Nitraria retusa extract in lipid profile in overweight and obese patients, during 10 days.
This study will be carried out in 2 departments: the laboratory of biophysics of the Faculty of Medicine of Sousse and Endocrinology and diabetology of CHU Farhat Hached Sousse ,Tunisia. At day 0 and day 10 all the population will benifit of biological assessment which include:
- Biochimical parameters
- Complete lipid profile (Total Cholesterol (T-C), High-density Lipoprotein (HDL) Low-density Lipoprotein (LDL) and Triglycerides( TG) .
- Blood sugar
- Liver Function Test : Alkaline phosphatase (ALP), gamma-glutamyltransferase (G-GT), albumin, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total ( TB) and direct bilirubin (DB).
- Renal Function Test : Serum Creatinine, urea
- Inflammatory assessment: Reactive protein C
- Hematological parameters : (Red blood cells (RBC), White blood cell (WBC), Platelet, Hemoglobin and Hematocrit).
All Population will be randomized :Participant will be assigned to one of two treatments (low dose flavonoids or high dose flavonoids ). The diatry supplement :Nitraria retusa infusion will be prescribed at a quantity of powder which contained 5 mg of flavonoids or which contained 20 mg of flavonoids , added to 100 ml of boiling water and will be taken once a day at a bed time for 10 consecutive days.
Statistical analysis Data entry and analysis will be performed using SPSS 22.0 for Windows(IBM Corp., NY, USA ). Results will be considered significant at p < 0.05 Normal distributions of the data will be assessed by Shapiro-Wilk test. Within-group differences in the biological parameters before and after the intervention will be compared using paired t-test when data are normally distributed and Wilcoxon Signed Rank Test when data are not normaly distrubuted. Between-group differences (low dose vs high dose) in the parameters will be assessed by independent samples t-test (parametric and equal variances), Welch's t-test (unequal variances) and Mann-Whitney U test (nonparametric)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental 1: low dose group | Experimental | Dietary Supplement: Tea infusionTea infusion which contain 5 mg of flavonoids, (low dose of flavonoids treatment quantification) oral administration , once daily. |
| Experimental 2 : high dose group | Experimental | Dietary Supplement: Tea infusionTea infusion which contain 20 mg of flavonoids, ( high dose of flavonoids Treatment quantification) oral administration , once daily . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females
- age range of 18 and 75 years
- BMI >25 kg/ m^2
Key exclusion criteria (11 listed)
- Hypertension
- Diabetes
- Asthma
- Smoking
- Professional athletic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tea infusionTea infusion: The aerial parts of the medicinal plant were dried, then, they were powdered in a rotating knife grinder. The herbs were taken as tea infusion by the oral route. The powder was added to 100 ml of boiling water and the tea infusion was taken once time a day at the bed time and it was repeated for 10 days. | Dietary supplement | Experimental 1: low dose group, Experimental 2 : high dose group |
Primary outcome
Change in serum Triglycerides (TG) levels
Time frame: 10 days
To evaluate the efficacy of 20 mg of flavonoids in reducing serum TG compared with low dose group ( 5 mg of flavonoids) after 10 days administration .
Change in serum High Density Lipoprotein Cholesterol (HDL-C) levels
Time frame: 10 days
To evaluate the efficacy of 20 mg of flavonoids in increasing HDL-C levels compared with low dose group ( 5 mg of flavonoids) after 10 days administration
Change in Total Cholesterol ( TC) levels
Time frame: 10 days
To evaluate the efficacy of 20 mg of flavonoids in reducing TC levels compared with low dose group ( 5 mg of flavonoids) after 10 days administration.
Change in Low Density Lipoprotein Cholesterol (LDL-C) levels
Time frame: 10 days
To evaluate the efficacy of 20 mg of flavonoids in reducing LDL-C levels compared with low dose group ( 5 mg of flavonoids) after 10 days administration
17 secondary outcomes
no change from baseline in Alkaline phosphatase levels
Time frame: 10 days
no change from baseline in Aspartate aminotransferase levels.
Time frame: 10 days
no change from baseline in Alanine aminotransferase levels.
Time frame: 10 days
no change from baseline in gamma-glutamyltransferase levels.
Time frame: 10 days
no change from baseline in Albumin levels .
Time frame: 10 days
no change from baseline in total bilirubin levels
Time frame: 10 days
no change from baseline in direct bilirubin levels
Time frame: 10 days
no change from baseline in urea levels
Time frame: 10 days
no change from baseline in creatinine levels
Time frame: 10 days
no change from baseline in fasting blood glucose levels
Time frame: 10 days
no change from baseline in Red blood cells levels
Time frame: 10 days
no change from baseline in White blood cells levels
Time frame: 10 days
no change from baseline in Hemoglobin levels
Time frame: 10 days
no change from baseline in Hematocrit levels
Time frame: 10 days
no change from baseline in Platelets levels
Time frame: 10 days
no change from baseline in Hemodynamic indicators: heart rate and blood pressure : systolic blood pressure and diastolic blood pressure
Time frame: 10 days
Adverse events
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 21951288Boubaker J, Bhouri W, Ben Sghaier M, Ghedira K, Dijoux Franca MG, Chekir-Ghedira L. Ethyl acetate extract and its major constituent, isorhamnetin 3-O-rutinoside, from Nitraria retusa leaves, promote apoptosis of human myelogenous erythroleukaemia cells. Cell Prolif. 2011 Oct;44(5):453-61. doi: 10.1111/j.1365-2184.2011.00772.x.
- Background: PubMed 22040460Boubaker J, Bhouri W, Sghaier MB, Bouhlel I, Skandrani I, Ghedira K, Chekir-Ghedira L. Leaf extracts from Nitraria retusa promote cell population growth of human cancer cells by inducing apoptosis. Cancer Cell Int. 2011 Oct 31;11(1):37. doi: 10.1186/1475-2867-11-37.
- Background: PubMed 28198206Chaabane M, Koubaa M, Soudani N, Elwej A, Grati M, Jamoussi K, Boudawara T, Ellouze Chaabouni S, Zeghal N. Nitraria retusa fruit prevents penconazole-induced kidney injury in adult rats through modulation of oxidative stress and histopathological changes. Pharm Biol. 2017 Dec;55(1):1061-1073. doi: 10.1080/13880209.2016.1278455.
- Background: PubMed 30391934Hashempur MH, Mosavat SH, Heydari M, Shams M. Medicinal plants' use among patients with dyslipidemia: an Iranian cross-sectional survey. J Complement Integr Med. 2018 Nov 3;16(3):/j/jcim.2019.16.issue-3/jcim-2018-0101/jcim-2018-0101.xml. doi: 10.1515/jcim-2018-0101.
- Background: PubMed 25086370Zar Kalai F, Han J, Ksouri R, Abdelly C, Isoda H. Oral administration of Nitraria retusa ethanolic extract enhances hepatic lipid metabolism in db/db mice model 'BKS.Cg-Dock7(m)+/+ Lepr(db/)J' through the modulation of lipogenesis-lipolysis balance. Food Chem Toxicol. 2014 Oct;72:247-56. doi: 10.1016/j.fct.2014.07.029. Epub 2014 Jul 30.
- Background: PubMed 30742925Rjeibi I, Feriani A, Hentati F, Hfaiedh N, Michaud P, Pierre G. Structural characterization of water-soluble polysaccharides from Nitraria retusa fruits and their antioxidant and hypolipidemic activities. Int J Biol Macromol. 2019 May 15;129:422-432. doi: 10.1016/j.ijbiomac.2019.02.049. Epub 2019 Feb 8.
- Background: PubMed 24367387Zar Kalai F, Han J, Ksouri R, El Omri A, Abdelly C, Isoda H. Antiobesity Effects of an Edible Halophyte Nitraria retusa Forssk in 3T3-L1 Preadipocyte Differentiation and in C57B6J/L Mice Fed a High Fat Diet-Induced Obesity. Evid Based Complement Alternat Med. 2013;2013:368658. doi: 10.1155/2013/368658. Epub 2013 Dec 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tea infusion in people with Overweight and Obesity, run by Laouani Aicha at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum Triglycerides (TG) levels (time frame: 10 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05824039, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.