Investigation of the effect of trehalose on CRP, disability and complication of stroke in ischemic stroke patients: a randomized controlled trial

Investigation of the effect of trehalose on CRP, disability and complication of stroke in ischemic stroke patients

Parallel randomized controlled trial phase 2 with control group

َIschemic stroke patients admitted in neurology ward or stroke care unit(SCU) of Ghaem Hospital, will be enrolled to this study. After informed consent, they will be randomly divided into 2groups of intervention and control. The intervention group will received two 30g sachets of trehalose in the first 24 hours, then 30g daily till 5 days. The mentioned outcomes will be assessed at 5 days(or at the time of discharge). Complications of stroke will be evaluated monthly until 3 months.

Inclusion criteria: Patients with ischemic stroke, Age more than 18 years old, Satisfaction for participation in research project (by the patient or his guardian), NISS score between 5-25 or less than 5 with aphasia, ataxia, or anopia. Exclusion criteria: Willingness to withdraw from the study, Pregnancy or breastfeeding

Intervention group: Two doses of 30 gr sachet of trehalose in the first 24 hours, then once daily till 5 days (or until discharge in case of discharge earlier than 5 days). Trehalose is made by Shaanxi Fruiterco Biotechnology Co.,Ltd. Control group: Two sachets of erythritol in the first 24 hours, then once daily till 5 days (or until discharge in case of discharge earlier than 5 days).

Primary outcomes: CBC, C-reactive protein (CRP), National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS) at baseline and at 5 days (or at discharge in case of discharge earlier than 5 days). MRS will be assessed again at 1 and 3 months. Secondary outcomes: Complications of stroke such as recurrent stroke, transient ischemic attack (TIA), myocardial infarction (MI), bleeding, and mortality.

First, the patients stratified to two groups of receiving/not receiving treatments of acute phase (such as thrombectomy or rTPA). Then, the block randomization will be performed in each stratum using the block sizes of 4 and 6 with randomization websites such as sealedenvelope.com. After randomization, the type of treatment is written with odds and even numbers (or A/B codes) in separate papers and placed in an opaque envelope; or the paper will be wrapped so that no one can see inside the paper (allocation concealment). After obtaining informed consent from the participants, one paper will be taken in order and according to the written code, the participant will be placed in one of the intervention or placebo groups.

As mentioned before, after randomization, the patients will be placed in two groups of A/B (or odds/even codes) and received the products similar in shape, color and size (blinding of participants). The physician who will give the products to participants, will received the boxes of the products with randomized codes (so the physician is blind too). The information of the patients and theirs treatment groups will be written with randomized codes (A/B) (the blinding of the assessor). Data will be entered to the SPSS software with codes (the blinding of the analyzer).