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Effectiveness of magnesium sulphate as an adjuvant therapy compared to standard treatment in patients with acute oleander poisoning in selected hospitals, Sri Lanka

Effectiveness of magnesium sulphate as an adjuvant therapy compared to standard treatment in patients with acute oleander poisoning in selected hospitals, Sri Lanka.: A double-blind randomized controlled trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2025/019
Enrollment
Unknown
Registered
2025-04-30
Start date
2025-05-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute oleander poisoning

Interventions

Study Settings - Teaching Hospital Batticaloa and Teaching Hospital Kurunegala Randomization: Patients presenting with acute oleander poisoning within 6 hours of ingestion, who meet the inclusion/exc

Sponsors

Research Council - Univeristy of Sri Jayewardenepura
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. The patient should be admitted to the study hospital within 6 hours of oleander ingestion 2. Patients should have signs and symptoms suggestive of systemic oleander poisoning: Presence of any of the following signs within first 2 hours of admiss ion would be considered as evidence of systemic intoxication. - Bradycardia with a heart rate of less than 60 beats /minute - Presence of reverse tick sign of digoxin effect in ECG - Systolic blood pressure less than 80 Hg mm 3. Symptoms such as nausea, vomiting, abdominal pain, diarrheoa, xanthopsia

Exclusion criteria

Exclusion criteria: 1. Patients below 16 years of age 2. Pregnant women 3. Patients with a history of ischemic or valvular heart disease 4. Patient with a history of significant cardiac diseases 5. Patients with a history of co-poisoning with other pharmacological agents which affect heart rate, such as calcium-channel blockers, beta-blockers, amiodarone and other antiarrhythmic drugs 6. Patients who were on medication which affect heart rate and rhythm, such as calcium-channel blockers, beta-blockers, amiodarone and other antiarrhythmic drugs. 7. Patients who were already given oral magnesium sulphate following acute oleander poisoning

Design outcomes

Primary

MeasureTime frame
Case fatality rate - by observing number of deaths [At any given point of the hospital stay of the patient (at point of patient death)] Incidence of development of brady-arrhythmias (According to ECGs) [Within the first 24 hours of admission] Percentage of deaths [At any given point of the hospital stay of the patient (at point of patient death)] Percentage of deaths [At any given point of the hospital stay of the patient (at point of patient death)] Percentage of deaths [At any given point of the hospital stay of the patient (at point of patient death)]

Secondary

MeasureTime frame
Incidence of symptomatic brady-arrhythmias (1st degree/ second degree/ third degree Atrio-ventricular blocks) - using 4 hourly ECGs for first 24 hours [With in the first 24 hours of admission - at the point of developing the arrhythmia] Incidence of hyperkalemia and hypokalemia - by collecting blood on admission and every 6 hourly for first 24 hours [ With in the first 24 hours of admission - at the point of development of hyperkalemia and/or hypokalemia] Incidence of temporary cardiac pacing [ With in the first 24 hours of admission at the point when patient is subjected to temporary cardiac pacing] Duration of hospital stay [ At discharge] Incidence of tachy-arrhythmias - using 4 hourly ECGs for first 24 hours [ With in the first 24 hours of admission - at the point of development of the arrhythmia ] Reversal of brady-arrhythmias - using 4 hourly ECGs for first 24 hours [With in the first 24 hours of admission - at the point the arrhythmia is developed ]

Countries

Sri Lanka

Contacts

Public ContactDr. W.M.A.B.W. Eriyawa

Lecturer in Pharmacology

asankaeriyawa@wyb.ac.lk

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026