Treatment Resistant SchizophreniaNCT07817069
Effects of Nitraria Retusa Infusion on Clozapine-induced Metabolic Side Effects
A study testing The Nitraria retusa arm in people with Treatment Resistant Schizophrenia and Obesity & Overweight, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
Trial summary
The primary objective of the study is to assess the efficacy and tolerability of a 90-day daily supplementation with a Nitraria retusa dried crushed leaves infusion on the iatrogenic metabolic side effects induced in patients with treatment-resistant schizophrenia following clozapine treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Schizophrenia, Obesity & Overweight, Abdominal Obesity
- What is being tested?
- The Nitraria retusa arm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTunisia
- Study dates
- 3 Jan 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of treatment-resistant schizophrenia;
- current treatment with clozapine monotherapy or clozapine combined with other psychotropics that have a minimal documented impact on body weight; - demonstration of a response to clozapine, defined as a reduction of at least 20% in the total score on the Positive and Negative Syndrome Scale (PANSS) or the Brief Psychiatric Rating Scale (BPRS) after 8-12 weeks of treatment at effective therapeutic doses;
- presence of obesity (BMI > 30 kg/m²) or central obesity (waist circumference > 94 cm in men and > 80 cm in women), which developed following clozapine introduction.
- free informed written consent
Who cannot join
- concurrent use of clozapine with other psychotropic agents that have a documented moderate-to-high influence on body weight
- current treatment with metformin
- pregnancy or breastfeeding
- non acceptance to take part to the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
Farhat Hached University Hospital
Sousse, 4000
Bochra Nourhène Saguem, M.D.; Associate Professor, +21655617728, saguem.bochra@gmail.com
Jaâfar Nakhli, Professor
About this study
Official title: Efficacy of Nitraria Retusa Infusion in Significantly Reducing Clozapine-induced Metabolic Side Effects in Patients With Treatment-resistant Schizophrenia: A Pre-Experimental Pilot Study
The primary objective of the study is to assess the efficacy and tolerability of a 90-day daily supplementation with a Nitraria retusa dried crushed leaves infusion on the iatrogenic metabolic side effects induced in patients with treatment-resistant schizophrenia following clozapine treatment.
After providing written informed consent, eligible patients with treatment-resistant schizophrenia will be invited to receive a daily Nitraria retusa extract infusion at approximately 9 PM for 90 consecutive days, as an adjunct to their usual medications. Patients will be instructed to maintain their usual diet, routine, and lifestyle throughout the study.
Clinical and biological evaluations will be conducted prospectively at baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3). Two additional assessments will be planned at day 30 and day 60 to comply with the monthly complete blood count (CBC) surveillance recommended for patients receiving clozapine. Assessments include anthropometric measures, body composition, vital signs, CBC, metabolic panels, and renal and hepatic function. All biological samples were collected after a 12-hour fast.
Read the detailed description
A pilot, pre-experimental study will be conducted.
- Study population Patients will be recruited from the outpatient Department of Psychiatry at Farhat Hached Hospital (Sousse, Tunisia). Inclusion criteria are: (1) a diagnosis of treatment-resistant schizophrenia; (2) current treatment with clozapine monotherapy or clozapine combined with other psychotropics that have a minimal documented impact on body weight; (3) demonstration of a response to clozapine, defined as a reduction of at least 20% in the total score on the Positive and Negative Syndrome Scale (PANSS) or the Brief Psychiatric Rating Scale (BPRS) after 8-12 weeks of treatment at effective therapeutic doses; and (4) presence of obesity (Body Mass Index (BMI) > 30 kg/m²) or central obesity (waist circumference > 94 cm in men and > 80 cm in women), which developed following clozapine introduction. Non-inclusion criteria are: (1) concurrent use of clozapine with other psychotropic agents that have a documented moderate-to-high influence on body weight; (2) current treatment with metformin; and (3) pregnancy or breastfeeding.
- Study procedure Eligible patients with treatment-resistant schizophrenia will be invited to take a daily Nitraria retusa extract infusion at approximately 9 PM for 90 consecutive days, as an adjunct to their usual medications. Patients will be instructed to maintain their usual diet, routine, and lifestyle throughout the study. Clinical and biological evaluations will be conducted prospectively at baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3).
- Plant material and preparation of Nitraria retusa extract Nitraria retusa was collected from saline soils in Kairouan (central Tunisia). The leaves were rinsed with water, air-dried in the shade at room temperature for 15 days, and crushed into a fine powder using a Moulinex grinder (MOULINEX SA, France). Nitraria retusa was supplied to participants in sachets containing 2,000 mg of powder. Participants were instructed to prepare the daily infusion by steeping 2,000 mg of the powder in 100 mL of boiled water for 15 minutes. Qualitative and quantitative analyses of the extract were performed using a validated ultra-high-performance liquid chromatography with diode-array detection method (UHPLC-DAD; SHIMADZU 8045).
- Outcome variables Outcome measures were categorized as primary and secondary. Primary outcomes included:
- Body weight, measured using a calibrated scale integrated into the bioelectrical impedance analyzer, with participants wearing light clothing.
- Waist circumference, measured at the narrowest point between the lower rib margin and the iliac crest, as an indicator of abdominal adiposity. Secondary outcomes encompassed:
- Other anthropometric measurements including mid-upper arm circumference measured at the midpoint of the relaxed arm, and mid-thigh circumference measured at the midpoint of the thigh.
- Body composition, assessed via bioelectrical impedance analysis, including body fat, muscle mass, and body water percentages.
- Metabolic panels, including triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), fasting blood glucose, and glycated hemoglobin (HbA1c).
- Intervention tolerability, monitored via CBC, renal function markers, and hepatic enzymes.
- Ethical considerations Each participant provided written informed consent after receiving a detailed oral explanation of the study objectives and procedure, and after being given the written information sheet. Participants were also informed about their rights to withdraw at any time without any impact on the quality of their clinical care. All data were handled confidentially.
- Being tested
- The Nitraria retusa arm
- Keywords
- Nitraria retusa, Flavonoids, Clozapine, Treatment-resistant schizophrenia, Metabolic syndrome, Obesity, Antipsychotic-induced weight gain
- Medical subject headings
- Schizophrenia, Treatment-Resistant, Obesity, Overweight, Obesity, Abdominal, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Nitraria retusa armDietary supplement
A daily administration of Nitraria retusa extract infusion at approximately 9 PM for 90 consecutive days, as an adjunct to patients' usual medications, while maintaining usual diet, routine, and lifestyle throughout the study.
Nitraria retusa was collected from saline soils in Kairouan (central Tunisia). The leaves were rinsed with water, air-dried in the shade at room temperature for 15 days, and crushed into a fine powder using a Moulinex grinder (MOULINEX SA, France). Nitraria retusa was supplied to participants in sachets containing 2,000 mg of powder. Participants were instructed to prepare the daily infusion by steeping 2,000 mg of the powder in 100 mL of boiled water for 15 minutes. Qualitative and quantitative analyses of the extract were performed using a validated high-performance liquid chromatography method (UHPLC-DAD, SHIMADZU 8045).
| Study group | Role | What they receive |
|---|---|---|
| Treatment-resistant schizophrenia patients' with clozapine-induced obesity | Experimental | Inclusion criteria: (1) a diagnosis of treatment-resistant schizophrenia]; (2) current treatment with clozapine monotherapy or clozapine combined with other psychotropics that have a minimal documented impact on body weight; (3) demonstration of a response to clozapine, defined as a reduction of at least 20% in the total score on the Positive and Negative Syndrome Scale (PANSS) or the Brief Psychiatric Rating Scale (BPRS) after 8-12 weeks of treatment at effective therapeutic doses; and (4) presence of obesity (BMI > 30 kg/m²) or central obesity (waist circumference > 94 cm in men and > 80 cm in women), which developed following clozapine introduction.
Non-inclusion criteria: (1) concurrent use of clozapine with other psychotropic agents that have a documented moderate-to-high influence on body weight; (2) current treatment with metformin; and (3) pregnancy or breastfeeding. Receives: Dietary Supplement: The Nitraria retusa arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight, measured using a calibrated scale integrated into the bioelectrical impedance analyzer, with participants wearing light clothing.
Measured: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Waist circumference
Waist circumference, measured at the narrowest point between the lower rib margin and the iliac crest, as an indicator of abdominal adiposity.
Measured: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Secondary outcomes (8)
Other anthropometric measurements
Other anthropometric measurements including mid-upper arm circumference measured at the midpoint of the relaxed arm, and mid-thigh circumference measured at the midpoint of the thigh.
Measured: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Body composition
Body composition, assessed via bioelectrical impedance analysis, including body fat percentage, muscle mass percentage, and body water percentage.
Measured: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Concentration of Triglycerides
Fasting serum triglyceride (TG) concentration
Measured: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Concentration of High-Density Lipoprotein Cholesterol
Fasting serum High-Density Lipoprotein Cholesterol (HDL-C) concentration
Measured: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Concentration of Low-Density Lipoprotein Cholesterol
Fasting serum Low-Density Lipoprotein Cholesterol (LDL-C) concentration
Measured: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Fasting Blood Glucose Level
Fasting plasma glucose concentration
Measured: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Glycated Hemoglobin (HbA1c) Level
Percentage of glycated hemoglobin (HbA1c)
Measured: baseline (T0) and day 90 (T3)
Incidence of treatment-emergent abnormalities in Complete Blood Count, renal function, and hepatic Enzymes
Number of participants with clinically significant treatment-emergent abnormalities in complete blood count (CBC), renal function markers, or hepatic enzymes during the 90-day intervention period.
Measured: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start3 Jan 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant SchizophreniaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine, Sousse
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tsukuba
- Responsible party
- Principal investigator, Bochra Nourhène Saguem, Faculty of Medicine, Sousse
- Investigators
- Saad Saguem, Professor, Study director, Faculty of Medicine, Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817069
- Sponsor's protocol ID
- CEFMS 136/2022
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share anonymous results of the primary and secondary outcome variables of each study participant in form of Tables.
Publications
Yao J, Zhang Y, Zhao J, Wang XZ, Lin YP, Sun L, Lu QY, Fan GJ. Efficacy of flavonoids-containing supplements on insulin resistance and associated metabolic risk factors in overweight and obese subjects: a systematic review and meta-analysis of 25 randomized controlled trials. Front Endocrinol (Lausanne). 2022 Jul 22;13:917692. doi: 10.3389/fendo.2022.917692. eCollection 2022.
PubMed 35937836Laouani A, Nasrallah H, Sassi A, Ferdousi F, Kalai FZ, Hasni Y, Limem K, Isoda H, Saguem S. Exploring the Effects of Short-Term Daily Intake of Nitraria retusa Tea on Lipid Profile: A Pre-Post, Uncontrolled Pilot Study in Both Healthy and Overweight/Obese Adults. Nutrients. 2023 Aug 20;15(16):3649. doi: 10.3390/nu15163649.
PubMed 37630839Laouani A, Nasrallah H, Sassi A, Ferdousi F, Kalai FZ, Hasni Y, Isoda H, Saguem S. Antiobesity and Hypolipidemic Potential of Nitraria retusa Extract in Overweight/Obese Women: A Randomized, Double-Blind, Placebo-Controlled Pilot Study. Nutrients. 2024 Jan 21;16(2):317. doi: 10.3390/nu16020317.
PubMed 38276555Yuen JWY, Kim DD, Procyshyn RM, Panenka WJ, Honer WG, Barr AM. A Focused Review of the Metabolic Side-Effects of Clozapine. Front Endocrinol (Lausanne). 2021 Feb 25;12:609240. doi: 10.3389/fendo.2021.609240. eCollection 2021.
PubMed 33716966
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nitraria Retusa Infusion in Significantly Reducing Clozapine-induced Metabolic Side Effects in Patients With Treatment-resistant Schizophrenia: A Pre-Experimental Pilot Study
- ClinicalTrials.gov ID
- NCT07817069
- Acronym / sponsor ID
- CEFMS 136/2022
- Keywords
- Nitraria retusa, Flavonoids, Clozapine, Treatment-resistant schizophrenia, Metabolic syndrome, Obesity, Antipsychotic-induced weight gain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Faculty of Medicine, SousseUniversity, hospital or other
- Collaborators
- University of Tsukuba
- Study start
- 3 Jan 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Sep 2026 (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 primary objective of the study is to assess the efficacy and tolerability of a 90-day daily supplementation with a Nitraria retusa dried crushed leaves infusion on the iatrogenic metabolic side effects induced in patients with treatment-resistant schizophrenia following clozapine treatment.
After providing written informed consent, eligible patients with treatment-resistant schizophrenia will be invited to receive a daily Nitraria retusa extract infusion at approximately 9 PM for 90 consecutive days, as an adjunct to their usual medications. Patients will be instructed to maintain their usual diet, routine, and lifestyle throughout the study.
Clinical and biological evaluations will be conducted prospectively at baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3). Two additional assessments will be planned at day 30 and day 60 to comply with the monthly complete blood count (CBC) surveillance recommended for patients receiving clozapine. Assessments include anthropometric measures, body composition, vital signs, CBC, metabolic panels, and renal and hepatic function. All biological samples were collected after a 12-hour fast.
Detailed description
A pilot, pre-experimental study will be conducted.
- Study population Patients will be recruited from the outpatient Department of Psychiatry at Farhat Hached Hospital (Sousse, Tunisia). Inclusion criteria are: (1) a diagnosis of treatment-resistant schizophrenia; (2) current treatment with clozapine monotherapy or clozapine combined with other psychotropics that have a minimal documented impact on body weight; (3) demonstration of a response to clozapine, defined as a reduction of at least 20% in the total score on the Positive and Negative Syndrome Scale (PANSS) or the Brief Psychiatric Rating Scale (BPRS) after 8-12 weeks of treatment at effective therapeutic doses; and (4) presence of obesity (Body Mass Index (BMI) > 30 kg/m²) or central obesity (waist circumference > 94 cm in men and > 80 cm in women), which developed following clozapine introduction. Non-inclusion criteria are: (1) concurrent use of clozapine with other psychotropic agents that have a documented moderate-to-high influence on body weight; (2) current treatment with metformin; and (3) pregnancy or breastfeeding.
- Study procedure Eligible patients with treatment-resistant schizophrenia will be invited to take a daily Nitraria retusa extract infusion at approximately 9 PM for 90 consecutive days, as an adjunct to their usual medications. Patients will be instructed to maintain their usual diet, routine, and lifestyle throughout the study. Clinical and biological evaluations will be conducted prospectively at baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3).
- Plant material and preparation of Nitraria retusa extract Nitraria retusa was collected from saline soils in Kairouan (central Tunisia). The leaves were rinsed with water, air-dried in the shade at room temperature for 15 days, and crushed into a fine powder using a Moulinex grinder (MOULINEX SA, France). Nitraria retusa was supplied to participants in sachets containing 2,000 mg of powder. Participants were instructed to prepare the daily infusion by steeping 2,000 mg of the powder in 100 mL of boiled water for 15 minutes. Qualitative and quantitative analyses of the extract were performed using a validated ultra-high-performance liquid chromatography with diode-array detection method (UHPLC-DAD; SHIMADZU 8045).
- Outcome variables Outcome measures were categorized as primary and secondary. Primary outcomes included:
- Body weight, measured using a calibrated scale integrated into the bioelectrical impedance analyzer, with participants wearing light clothing.
- Waist circumference, measured at the narrowest point between the lower rib margin and the iliac crest, as an indicator of abdominal adiposity. Secondary outcomes encompassed:
- Other anthropometric measurements including mid-upper arm circumference measured at the midpoint of the relaxed arm, and mid-thigh circumference measured at the midpoint of the thigh.
- Body composition, assessed via bioelectrical impedance analysis, including body fat, muscle mass, and body water percentages.
- Metabolic panels, including triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), fasting blood glucose, and glycated hemoglobin (HbA1c).
- Intervention tolerability, monitored via CBC, renal function markers, and hepatic enzymes.
- Ethical considerations Each participant provided written informed consent after receiving a detailed oral explanation of the study objectives and procedure, and after being given the written information sheet. Participants were also informed about their rights to withdraw at any time without any impact on the quality of their clinical care. All data were handled confidentially.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment-resistant schizophrenia patients' with clozapine-induced obesity | Experimental | Dietary Supplement: The Nitraria retusa armInclusion criteria: (1) a diagnosis of treatment-resistant schizophrenia]; (2) current treatment with clozapine monotherapy or clozapine combined with other psychotropics that have a minimal documented impact on body weight; (3) demonstration of a response to clozapine, defined as a reduction of at least 20% in the total score on the Positive and Negative Syndrome Scale (PANSS) or the Brief Psychiatric Rating Scale (BPRS) after 8-12 weeks of treatment at effective therapeutic doses; and (4) presence of obesity (BMI > 30 kg/m²) or central obesity (waist circumference > 94 cm in men and > 80 cm in women), which developed following clozapine introduction. Non-inclusion criteria: (1) concurrent use of clozapine with other psychotropic agents that have a documented moderate-to-high influence on body weight; (2) current treatment with metformin; and (3) pregnancy or breastfeeding. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a diagnosis of treatment-resistant schizophrenia;
- current treatment with clozapine monotherapy or clozapine combined with other psychotropics that have a minimal documented impact on body weight; - demonstration of a response to clozapine, defined as a reduction of at least 20% in the total score on the Positive and Negative Syndrome Scale (PANSS) or the Brief Psychiatric Rating Scale (BPRS) after 8-12 weeks of treatment at effective therapeutic doses;
- presence of obesity (BMI > 30 kg/m²) or central obesity (waist circumference > 94 cm in men and > 80 cm in women), which developed following clozapine introduction.
- free informed written consent
Key exclusion criteria (4 listed)
- concurrent use of clozapine with other psychotropic agents that have a documented moderate-to-high influence on body weight
- current treatment with metformin
- pregnancy or breastfeeding
- non acceptance to take part to the study
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 |
|---|---|---|
| The Nitraria retusa armA daily administration of Nitraria retusa extract infusion at approximately 9 PM for 90 consecutive days, as an adjunct to patients' usual medications, while maintaining usual diet, routine, and lifestyle throughout the study. Nitraria retusa was collected from saline soils in Kairouan (central Tunisia). The leaves were rinsed with water, air-dried in the shade at room temperature for 15 days, and crushed into a fine powder using a Moulinex grinder (MOULINEX SA, France). Nitraria retusa was supplied to participants in sachets containing 2,000 mg of powder. Participants were instructed to prepare the daily infusion by steeping 2,000 mg of the powder in 100 mL of boiled water for 15 minutes. Qualitative and quantitative analyses of the extract were performed using a validated high-performance liquid chromatography method (UHPLC-DAD, SHIMADZU 8045). | Dietary supplement | Treatment-resistant schizophrenia patients' with clozapine-induced obesity |
Primary outcome
Body weight
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Body weight, measured using a calibrated scale integrated into the bioelectrical impedance analyzer, with participants wearing light clothing.
Waist circumference
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Waist circumference, measured at the narrowest point between the lower rib margin and the iliac crest, as an indicator of abdominal adiposity.
8 secondary outcomes
Other anthropometric measurements
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Body composition
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Concentration of Triglycerides
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Concentration of High-Density Lipoprotein Cholesterol
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Concentration of Low-Density Lipoprotein Cholesterol
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Fasting Blood Glucose Level
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Glycated Hemoglobin (HbA1c) Level
Time frame: baseline (T0) and day 90 (T3)
Incidence of treatment-emergent abnormalities in Complete Blood Count, renal function, and hepatic Enzymes
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 35937836Yao J, Zhang Y, Zhao J, Wang XZ, Lin YP, Sun L, Lu QY, Fan GJ. Efficacy of flavonoids-containing supplements on insulin resistance and associated metabolic risk factors in overweight and obese subjects: a systematic review and meta-analysis of 25 randomized controlled trials. Front Endocrinol (Lausanne). 2022 Jul 22;13:917692. doi: 10.3389/fendo.2022.917692. eCollection 2022.
- Background: PubMed 37630839Laouani A, Nasrallah H, Sassi A, Ferdousi F, Kalai FZ, Hasni Y, Limem K, Isoda H, Saguem S. Exploring the Effects of Short-Term Daily Intake of Nitraria retusa Tea on Lipid Profile: A Pre-Post, Uncontrolled Pilot Study in Both Healthy and Overweight/Obese Adults. Nutrients. 2023 Aug 20;15(16):3649. doi: 10.3390/nu15163649.
- Background: PubMed 38276555Laouani A, Nasrallah H, Sassi A, Ferdousi F, Kalai FZ, Hasni Y, Isoda H, Saguem S. Antiobesity and Hypolipidemic Potential of Nitraria retusa Extract in Overweight/Obese Women: A Randomized, Double-Blind, Placebo-Controlled Pilot Study. Nutrients. 2024 Jan 21;16(2):317. doi: 10.3390/nu16020317.
- Background: PubMed 33716966Yuen JWY, Kim DD, Procyshyn RM, Panenka WJ, Honer WG, Barr AM. A Focused Review of the Metabolic Side-Effects of Clozapine. Front Endocrinol (Lausanne). 2021 Feb 25;12:609240. doi: 10.3389/fendo.2021.609240. eCollection 2021.
- Individual participant dataSharing planned: Yes. The investigators plan to share anonymous results of the primary and secondary outcome variables of each study participant in form of Tables.
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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.
Saad Saguem, Professor study director
Faculty of Medicine, Sousse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Nitraria retusa arm in people with Treatment Resistant Schizophrenia and Obesity & Overweight, run by Faculty of Medicine, Sousse 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bochra Nourhène Saguem, M.D.; Associate Professor (+21655617728, saguem.bochra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)). The study lists 2 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 NCT07817069, which also lists 4 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 14 Sep 2026.