Aluminum Phosphide PoisoningPhase 3NCT07916922
Assessment of The Potential Therapeutic Effects of Trimetazidine on Aluminium Phosphide-Induced Cardiotoxicity as an Adjuvant Therapy: A Pilot Study
A Phase 3 study testing Trimetazidine and Standard Treatment in people with Aluminum Phosphide Poisoning, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Aluminum Phosphide Poisoning
- What is being tested?
- Trimetazidine and Standard Treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2026to Dec 2026
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with diagnosis of acute aluminum phosphide poisoning.
- Poison severity score 2 or 3 .
Who cannot join
- Patients less than 18 years and more than 60 years.
- Pregnant and lactating females.
- Presence of medical diseases (e.g. renal, hepatic, cardiovascular, neurological diseases and chronic pancreatitis.)
- Presence of co-ingestion of other drugs or agents.
- Pre consultation treatment.
- Patients with known hypersensitivity for any agents or drugs especially trimetazidine formulations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university
Cairo, Abbassia
Sarah A Eweda, Associate professor, +201151157622, onlysms@med.asu.edu.eg
About this study
Official title: Exploration of Potential Pathways to Mitigate the Toxicity of Some Pesticides
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.
Read the detailed description
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
- Conditions
- Aluminum Phosphide Poisoning
- Being tested
- Trimetazidine, Standard Treatment
- Keywords
- aluminum phosphide poisoning, Trimetazidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrimetazidineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment (Control Group) | Active comparator | 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. Receives: Drug: Standard Treatment |
| Trimetazidine Plus Standard Treatment | Experimental | 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. Receives: Drug: Trimetazidine; Drug: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Number of participants who die within 7 days after hospital admission.
Measured: Within 1 week
Secondary outcomes (4)
Systolic blood pressure
Maintain systolic blood pressure with adequate organ perfusion
Measured: within first 24 hours
hospital stay duration
duration of hospital stay measured in hours
Measured: 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
Measured: within first 48 hours after admission
ICU stay duration
Duration of ICU stay measured in hours
Measured: From ICU admission to ICU discharge up to 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start5 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aluminum Phosphide PoisoningStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Science,Technology & Innovation Funding Authority, Egypt, Mansoura University
- Responsible party
- Sponsor
- Investigators
- Mohammed Sh El-Awady, Professor, Study chair, Pharmacology and Toxicology, Faculty of Pharmacy, Mansoura UniversityMaha H Sharawy, Professor, Study director, Pharmacology and Toxicology, Faculty of Pharmacy, Mansoura UniversitySarah A Eweda, associate professor, Study director, Ain Shams UniversityMahmoud M Samaha, Lecturer, Study director, Pharmacology and Toxicology, Faculty of Pharmacy, Mansoura UniversityEntsar A Elnabet, PHD student, Principal investigator, Pharmacology and Toxicology, Faculty of Pharmacy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916922
- Sponsor's protocol ID
- MD77/2024
- Status last verified
- Sep 2026
- First submitted
- 15 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Hosseini SF, Forouzesh M, Maleknia M, Valiyari S, Maniati M, Samimi A. The Molecular Mechanism of Aluminum Phosphide poisoning in Cardiovascular Disease: Pathophysiology and Diagnostic Approach. Cardiovasc Toxicol. 2020 Oct;20(5):454-461. doi: 10.1007/s12012-020-09592-4.
PubMed 32712815El Shehaby DM, Sayed SA, Abd El-Kareem DM, Elsherif R, Almaz D. Trimetazedine with hyperinsulinimea-euoglycemia, N-acetyl cysteine, and vitamin C: A new approach concept for management of aluminum phosphide poisoning. J Biochem Mol Toxicol. 2022 Jan;36(1):e22931. doi: 10.1002/jbt.22931. Epub 2021 Oct 19.
PubMed 34665895
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Potential Pathways to Mitigate the Toxicity of Some Pesticides
- ClinicalTrials.gov ID
- NCT07916922
- Acronym / sponsor ID
- MD77/2024
- Conditions
- Aluminum Phosphide Poisoning
- Keywords
- aluminum phosphide poisoning, Trimetazidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Science,Technology & Innovation Funding Authority, Egypt, Mansoura University
- Study start
- 5 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Nov 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.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment (Control Group) | Active comparator | Drug: Standard TreatmentParticipants 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. |
| Trimetazidine Plus Standard Treatment | Experimental | Drug: Trimetazidine, Drug: Standard TreatmentParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with diagnosis of acute aluminum phosphide poisoning.
- Poison severity score 2 or 3 .
Key exclusion criteria (6 listed)
- Patients less than 18 years and more than 60 years.
- Pregnant and lactating females.
- Presence of medical diseases (e.g. renal, hepatic, cardiovascular, neurological diseases and chronic pancreatitis.)
- Presence of co-ingestion of other drugs or agents.
- Pre consultation treatment.
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 |
|---|---|---|
| TrimetazidineTrimetazidine (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 | Drug | Trimetazidine Plus Standard Treatment |
| Standard TreatmentResuscitation 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. | Drug | Standard Treatment (Control Group), Trimetazidine Plus Standard Treatment |
Primary outcome
Mortality
Time frame: Within 1 week
Number of participants who die within 7 days after hospital admission.
4 secondary outcomes
Systolic blood pressure
Time frame: within first 24 hours
hospital stay duration
Time frame: From hospital admission until hospital discharge or in-hospital death up to 7days
Requirement for mechanical ventilation
Time frame: within first 48 hours after admission
ICU stay duration
Time frame: From ICU admission to ICU discharge up to 7days
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 4 Nov 2026.
- Background: PubMed 32712815Hosseini SF, Forouzesh M, Maleknia M, Valiyari S, Maniati M, Samimi A. The Molecular Mechanism of Aluminum Phosphide poisoning in Cardiovascular Disease: Pathophysiology and Diagnostic Approach. Cardiovasc Toxicol. 2020 Oct;20(5):454-461. doi: 10.1007/s12012-020-09592-4.
- Background: PubMed 34665895El Shehaby DM, Sayed SA, Abd El-Kareem DM, Elsherif R, Almaz D. Trimetazedine with hyperinsulinimea-euoglycemia, N-acetyl cysteine, and vitamin C: A new approach concept for management of aluminum phosphide poisoning. J Biochem Mol Toxicol. 2022 Jan;36(1):e22931. doi: 10.1002/jbt.22931. Epub 2021 Oct 19.
- Individual participant dataSharing planned: 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.
Related trials for Aluminum Phosphide Poisoning
Recruiting
Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning
Toxicity, Drug
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.
Mohammed Sh El-Awady, Professor study chair
Pharmacology and Toxicology, Faculty of Pharmacy, Mansoura University
Maha H Sharawy, Professor study director
Pharmacology and Toxicology, Faculty of Pharmacy, Mansoura University
Sarah A Eweda, associate professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trimetazidine and Standard Treatment in people with Aluminum Phosphide Poisoning, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 6 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 4 Nov 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sarah A Eweda, Associate professor (01151157622, onlysms@med.asu.edu..eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Within 1 week). 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 NCT07916922, which also lists 2 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 4 Nov 2026.