Phase-II clinical trial with atropine sulfate intranasal drops

An open labeled, comparative phase-II field study to assess the efficacy and safety of atropine sulfate intranasal drops in patients of organophosphorus poisoning or nerve gas exposure

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/07/003833

Enrollment

500

Registered

2013-07-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Confirmed / suspected cases of organophosphorus poisoning or nerve gas exposure

Interventions

Intervention1: Atropine Sulphate nasal drops: 0.3- 0.6 ml of 1% Atropine Sulphate nasal drops to be instilled deep in one or both nostrils of a supine patient. The duration of protocol therapy is once

Eligibility

Inclusion criteria

Inclusion criteria: • Suspected or confirmed victims of organo-phosphorus poisoning • Suspected or confirmed victims of nerve gas accident / attack / act of terrorism • Rescue workers exposed to suspected to have been exposed to nerve gas • Pregnancy no bar in very sick patients confirmed as having organophosphorus poisoning

Exclusion criteria

Exclusion criteria: • Where conventional medical treatment is available and the medical team decides in favor of conventional treatment only; • Patients having any contraindications like increased intraocular pressure (IOP), lung disease, unstable cardiac rhythm, tachycardia etc.; • Patients who have any medical condition which in the judgment of the investigator may render them in appropriate for participation in the trial

Design outcomes

Primary

Measure	Time frame
Reduction in mortality and severity of morbidity attributable to organophosphorus poisoning or nerve gas exposureTimepoint: Reduction in mortality and severity of morbidity attributable to organophosphorus poisoning or nerve gas exposure	—

Secondary

Measure	Time frame
Reduction in organophosphorus poisoning or nerve gas exposure induced toxicity symptoms with respect to parameters mentioned below:Timepoint: ï?? Level of atropinization ï?? Reversal of miosis ï?? Number of lives saved (independently or as part of larger therapy) ï?? Bioavailability curve in blood (if possible) ï?? Amelioration of local respiratory effects of nerve gas / organo-phosphorus	—

Countries

India

Contacts

Public ContactAseem Bhatnagar

Defence Research and Development Organisation

dr.aseembhatnagar@gmail.com23905172

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026