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RecruitingNCT04499885Updated Aug 5, 2020

Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning

An interventional study of Paraffin oil gastric lavage and Gastric lavage with saline and sodium bicarbonate 8.4% in Toxicity, Drug, sponsored by Sherief Abd-Elsalam. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2020-08-05.

Sponsored by Sherief Abd-Elsalam · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2020; still recruiting 6 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Drug-Related Side Effects and Adverse Reactions with a site in Egypt — 1 open to participants now, 1 under way, none of them phase 3. Drug-Related Side Effects and Adverse Reactions · Egypt.

Started
2020
with 1 other
No phase
Only one
of the 11
Registered
2nd of 11
by date

Among the 11 studies in Drug-Related Side Effects and Adverse Reactions with a site in Egypt, this one is one of 2 that started in 2020, is the only one with no phase, and was the 2nd registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

Observational6 · 0 open
Phase 32 · 0 open
Phase 42 · 0 open
No phasethis study1 · 1 open

By the year they started

First in 2018; this study’s year is marked. 2 started in 2020.

Size and results

Median enrollment 62 across the 5 interventional studies, 250 across the 6 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.

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02

Study summary

Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning.

Read the detailed description

The study aims to investigate the Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial

03

Conditions studied

  • Toxicity, Drug
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

    • Patients with symptomatic acute aluminum phosphide poisoning

Exclusion criteria

Exclusion Criteria:

    • Pregnant and lactating women

      • Asymptomatic patients with history of acute aluminum phosphide exposure.
      • Patients with ingestion or exposure to other substances in addition to aluminum phosphide.
      • Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure).
      • Patients with previous medical intervention (had gastric lavage in any medical center before admission).
      • Patients with disturbed consciousness level
      • Patients with post cardiac arrest cases
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (estimated)

Study arms

  • Active comparator
    Paraffin oil gastric lavafe

    Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution

    Device: Paraffin oil gastric lavage

  • Active comparator
    Saline gastric lavage

    Gastric lavage with saline and sodium bicarbonate

    Device: Gastric lavage with saline and sodium bicarbonate 8.4%

Interventions

  • DeviceParaffin oil gastric lavage

    Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution

    Also known as: Paraffin oil

  • DeviceGastric lavage with saline and sodium bicarbonate 8.4%

    Gastric lavage with saline and sodium bicarbonate 8.4%

    Also known as: Saline gastric lavage

06

What researchers measure

Primary outcomes

  1. Number of deaths

    The number of deaths

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2020 (actual). Primary completion is estimated for Dec 2030, 126 months after the start.

Of 71 non-industry interventional studies with no phase under Drug-Related Side Effects and Adverse Reactions, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 126 months is above that.

Counting every sponsor, half of 73 studies reached it within 26 months; a quarter within 12 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2020
First posted
Aug 5, 2020
StartActual
Jun 1, 2020
Primary completionEst.
Dec 1, 2030
CompletionEst.
Dec 10, 2030
Last update
Aug 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04499885
Lead sponsor
Sherief Abd-Elsalam
Responsible party
Sherief Abd-Elsalam (Ass. Prof. Tropical Medicine, Tanta University) — Sponsor-investigator
First posted
Aug 5, 2020
Start date
Jun 1, 2020
Primary completion
Dec 1, 2030 (estimated)
Completion
Dec 10, 2030 (estimated)
Last update
Aug 5, 2020

Study contacts

Sherief Abd-Elsalam, ass. prof.
Contact
sheriefabdelsalam@yahoo.com
00201147773440
Nadia Ezzat Helal, Ass. Prof.
principal investigator · Forensic medicine Department- Tanta University
Ayman Nagy, ass. Prof.
principal investigator · Forensic medicine Department- Tanta University
Ghada N. El-Sarnagawy, ass. Prof.
principal investigator · Forensic medicine Department- Tanta University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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