Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 7, 2025
Date Accepted: Apr 13, 2025
Clinical Efficacy and Safety of the Herbal Prescription, HH333 in Preventing Recurrent Stroke in Patients with Ischemic Stroke induced by Small Vessel Disease: A Study Protocol from a Multicenter, Double-blind, Randomized, Prospective, Pilot Clinical Trial
ABSTRACT
Background:
Patients with ischemic stroke are at high risk of recurrence, making preventive care an important factor. Recent retrospective observational studies suggested that HH333, an herbal prescription, has an inhibitory effect on stroke recurrence in small-vessel diseases.
Objective:
Here, we propose a protocol for evaluating the efficacy and safety of HH333 in patients with ischemic stroke induced by small vessel disease.
Methods:
In this multicenter, double-blind, randomized, prospective, pilot clinical trial, 236 patients with ischemic stroke caused by small vessel disease were recruited and randomly assigned to either the HH333 or the placebo group. The HH333 group will take two capsules of HH333 once daily for 720 days, whereas the placebo group will take HH333 placebo capsules in the same manner. The efficacy will be assessed using the recurrence rate of ischemic stroke, which will be assessed on days 30, 90, 180, 270, 360, 450, 540, 630, 720, and 750 after starting the medication. Safety will be evaluated by performing blood and urine tests and electrocardiography on days 30, 90, 180, 270, 360, 450, 540, 630, and 720 after starting the medication.
Results:
The study was funded in April 1, 2022 by the Ministry of Health and Welfare, Republic of Korea and recruitment for the study started on May 22, 2024. As of November 13, 2024, a total of 12 participants have been randomized.
Conclusions:
The protocol will provide a detailed process for a clinical trial evaluating the efficacy of preventing recurrent ischemic stroke caused by small vessel disease and improving neurologic symptoms and the safety of HH333 in ischemic stroke. The results of this study provide a basis for alternative treatments to prevent and treat ischemic stroke. Clinical Trial: The study protocol was registered with the Clinical Research Information Service (CRIS, KCT0009431; May 14, 2024).
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