A Phase 3 interventional study of Trimetazidine and Standard Treatment in Aluminum Phosphide Poisoning, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment
This study is designed as a pilot randomized controlled trial to investigate the potential role of trimetazidine (TMZ) as an adjuvant therapy in patients with acute Aluminum phosphide poisoning.
This clinical trial represents the human/clinical component of a PhD thesis investigating potential pathways to mitigate pesticide toxicity. The overall PhD research program comprises both experimental animal and human clinical studies; the present protocol describes only the clinical component involving patients with acute aluminum phosphide (ALP) poisoning.
This study is designed as a pilot randomized controlled trial to investigate the potential role of trimetazidine (TMZ) as an adjuvant therapy in patients with acute ALP poisoning. The study will be conducted at the Poison Control Center of Ain Shams University Hospitals (PCC-ASUH). Eligible adult patients (18-60 years) diagnosed with acute ALP poisoning and fulfilling the predefined inclusion and exclusion criteria will be enrolled. Patients will be randomly allocated into two groups. The control group will receive the standard supportive management according to the PCC-ASUH protocol, while the intervention group will receive the same standard treatment plus trimetazidine. The primary outcome will be mortality within one week. Secondary outcomes will include improvement in hemodynamic parameters, duration of hospital and ICU stay, requirement for mechanical ventilation, and duration of mechanical ventilation.
The study will be conducted following approval by the relevant ethical committee and the Poison Control Center administration. Written informed consent will be obtained from patients or their legal guardians, and confidentiality of participants' data will be maintained
98 studies on the registry are indexed under Poisoning; 16 are open to participants now.
This study's planned enrollment of 20 is below the median of 46 across 52 interventional studies indexed under Poisoning.
Browse Poisoning studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with acute aluminum phosphide poisoning will receive standard supportive treatment according to the Poison Control Center of Ain Shams University Hospitals (PCC-ASUH) protocol, without the addition of trimetazidine.
Drug: Standard Treatment
Participants will receive the traditional supportive treatment plus trimetazidine 35 mg MR tablet was suspended in 60 ml paraffin oil and given orally twice daily for 48 hours.
Drug: Trimetazidine · Drug: Standard Treatment
Trimetazidine (TMZ), Vastarel ® MR 35mg tablets, Servier, France, was purchased from a local pharmacy in Egypt and dissolved in 60ml Liquid paraffin oil (pharmaceutical grade; El-Ahram Medical Company, Egypt), was also purchased from a local pharmacy and used in the intervention protocol
Resuscitation and Supportive Care :Routine resuscitation, close observation, and supportive care will be provided to all patients. Ventilatory support and correction of metabolic acidosis .shock is treated guided by fluid challenge 5-10ml/kg, if no response norepinephrine IV infusion and Hydrocortisone IV 100-200mg every 4-6h will be started) , 60 ml paraffin oil by ryle and Antioxidant: IV N-acetylcysteine infusion , IV Magnesium sulphate if needed.
Mortality
Number of participants who die within 7 days after hospital admission.
Time frame: Within 1 week
Systolic blood pressure
Maintain systolic blood pressure with adequate organ perfusion
Time frame: within first 24 hours
hospital stay duration
duration of hospital stay measured in hours
Time frame: From hospital admission until hospital discharge or in-hospital death up to 7days
Requirement for mechanical ventilation
Number of participants requiring mechanical ventilation during hospitalization
Time frame: within first 48 hours after admission
ICU stay duration
Duration of ICU stay measured in hours
Time frame: From ICU admission to ICU discharge up to 7days
Plan to share: No — Individual participant data will not be shared with other researchers. Study data will be analyzed and reported in aggregate form to protect participants' privacy and confidentiality.
Started May 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Trimetazidine