At a glance
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Pilot Study of the Neuroprotective Effects of Hydrogen and Minocycline in Acute Ischemic Stroke
In Brief
A Phase 3 clinical trial evaluating Hydrogen, Minocycline, and 2 other interventions for Stroke, Ischemic. Completed, enrolled 15 participants across 1 site.
Detailed Summary
This is a pilot randomized control trial (RCT) to explore the possible beneficial effect of a novel combination therapy consisting of molecular hydrogen H2 plus minocycline ("H2M"), on neurological recovery after acute ischemic stroke.
Study Details
Timeline
Interventions
Hydrogen will be infused into bags of normal saline solution and administered intravenously, or hydrogen generating tablets will be dissolved into water for the patient to drink, as the patient's condition permits. This will be administered TID for 3 days.
Minocycline 200 mg will be mixed with normal saline and given by i.v. administration, or provided as capsules for the patient to swallow, q 24 hours for 5 days. Once patients regain the ability to swallow capsules, minocycline will be given orally in capsule form (2 capsules of 100 mg each), administered once daily for the remainder of the 5 day period.
Normal saline solution will be administered intravenously, in place of hydrogen solution. Placebo tablets will be dissolved into water for the patient to drink, as the patient's condition permits. This will be administered TID for 3 days.
Normal saline solution or placebo capsule will be administered i.v. or p.o. respectively, in place of minocycline.