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Effects of Nitraria Retusa Infusion on Clozapine-induced Metabolic Side Effects
Sponsor: Faculty of Medicine, Sousse
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. 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.
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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-01-03
Completion Date
2028-12
Last Updated
2026-09-14
Healthy Volunteers
No
Interventions
The Nitraria retusa arm
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).
Locations (1)
Farhat Hached University Hospital
Sousse, Tunisia