CTRI/2023/04/051678
Not yet recruiting
Phase 2
Evaluation of Safety and Efficacy of Injectable Glutathione as an adjuvant to Standard of Care in Scrub typhus induced Acute Respiratory Distress Syndrome (ARDS): A Phase II, Multi-centric, Open label, Randomized Controlled Trial. - GIST
Department of Health Research0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: J158- Pneumonia due to other specified bacteria
- Sponsor
- Department of Health Research
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients aged between 18\-60 years, of all gender with laboratory confirmed Scrub typhus which is evident by IgM Card test / Immunofluorescence Assay (IFA)
- •2\. Presence of mild to moderate Acute Respiratory Distress Syndrome (ARDS) as defined by the Berlin definition:
- •a) Bilateral infiltrates by chest radiograph
- •b) Oxygen saturation of less than 94% at rest on room air or the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2 ratio) of less than 300 and more than 100, and less than 48 hours from their hospital admission.
- •c) Absence of other clinical conditions that could present in a similar manner (cardiogenic pulmonary oedema, non\-infectious pneumonitis)
- •d) Absence of moribund state that would indicate imminent demise and poor chance of survival.
Exclusion Criteria
- •1\. Severe ARDS with PaO2/FiO2of \<100 mm Hg and need for mechanical ventilation at the time of enrolment,
- •2\. Chronic home oxygen therapy,
- •3\. Chronic Kidney Disease (e\-GFR of \<30ml/min), Chronic Liver Disease
- •4\. Use of any other antioxidant supplement outside the protocol
- •5\. Prior hypersensitivity to glutathione
- •6\. Pregnancy and lactation.
- •7\. Multi organ dysfunction syndrome on admission
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
The efficacy and safety of systemic injection of Ginkgo biloba extract, EGb761, in idiopathic sudden sensorineural hearing loss: a randomized placebo-controlled clinical trialDiseases of the ear and mastoid processKCT0001381Yuyu Phama60
Recruiting
Phase 1
Safety and effectiveness assessment of injectable suspension of Inshape x Radiance plus for the treatment of the back of hand wrinklesIRCT20150101020514N31ano Darou Pajouhan Pardis Company15
Recruiting
Phase 1
Investigating the effect of stromal/mesenchymal stem cell-derived exosomes in patients with perianal fistulaIRCT20240128060828N1Tehran University of Medical Sciences30
Recruiting
Phase 2
Safety and efficacy assessment of injectable gel with Perleux® brand, in order to rejuvenate facial skiIRCT20150101020514N17Zist orchid pharmed Company20
Recruiting
Phase 2
Safety and effectiveness of injectable gel with the Perjunse brandSkin aging.IRCT20150101020514N24Pars Fardad Nano Technology Company30