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Phase-II clinical trial with submicron sized alpha-ketoglutarate dry powder inhalation

An open labeled, comparative, step-up phase-2 clinical study to assess deposition and efficacy of sodium alpha-ketoglutarate DPI (submicron-sized) in prevention of hydrogen cyanide, methyl isocyanate (MIC) toxicity and ammonia gas exposure

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/01/003320
Enrollment
520
Registered
2013-01-23
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- Suspected or confirmed victims of cyanide poisoning, or Rescue workers entering or exposed to or suspected to have been exposed to fire, smoke, fumes, environments containing HCN/ MIC/ ammonia gas

Interventions

Intervention1: DPI respules of sub-micron sized Alpha-ketoglutarate (AKG): DPI respules containing 35 mg AKG of submicron size. Three DPI repsules form a unit dose (105 mg), that is to be inhaled thro

Sponsors

Defence Research and Development Organisation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Rescue workers just before entry in areas of fire, smoke, fumes (particularly where plastic is burning), environments containing hydrogen cyanide/ MIC/ ammonia gas; b) Suspected or confirmed victims of the above with moderate-to-severe symptoms while they are leaving the contaminated zone

Exclusion criteria

Exclusion criteria: a) Where conventional medical treatment is available and the medical team decides in favor of conventional treatment alone or no treatment at all; b) Where the team leader / participants rescue workers are unwilling to take the prophylaxis before entering the danger zones, or refusal by exposed patients to undertake the therapy; c) Subjects / Patients having any contraindications like severe breathlessness, unstable cardiac rhythm, tachycardia etc.; d) Subjects / Patients who have compromised lung function due to any cause; e) Patients who have any medical condition which in the judgment of the investigator may render them inappropriate for participation in the trial

Design outcomes

Primary

MeasureTime frame
Reduction in mortality and severity of morbidity attributable to hydrogen cyanide /MIC /ammonia gasTimepoint: Reduction in mortality and severity of morbidity attributable to hydrogen cyanide /MIC /ammonia gas

Secondary

MeasureTime frame
Reduction in hydrogen cyanide /MIC /ammonia gas induced toxicity symptoms with respect to parameters mentioned below:Timepoint: a) Level of consciousness b) Level of vital signs c) Reversal of level of dypnoea d) Number of lives saved (independently or as part of larger therapy) e) Comparison of signs & symptoms (blood oxygen or cyanide levels wherever possible) with subjects receiving similar amount of the poisonous inhalation but not receiving the antidote or receiving some other emergency therapy. f) Amelioration of local respiratory effects of the cyanide poisoning / MIC / ammonia gas

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