Ischaemic stroke represents one of the main causes of disability. According to the broad investigations, it is widely assumed that the contribution of inflammatory mediators is strongly involved in its pathogenesis. Hence, it seems that
stroke treatment needs more efficient and inflammatory-targeted compounds to modulate inflammatory-related pathways. Such strategies paved the way to achieve better clinical outcomes along with conventional
therapies. Boswellic
acids (BAs), the main bioactive compounds of Boswellia sp. resin; are
triterpenoids with well-documented anti-inflammatory properties. Compared with
NSAIDs, BAs cross blood-brain barrier yet they do not cause serious gastrointestinal adverse effects. Considering BAs anti-inflammatory features, we conducted a randomized double-blind placebo-controlled pilot trial of these compounds as a supplementary
therapy. This trial randomized 80
ischaemic stroke patients (40-80-years old) with a 4-20 score according to the National Institutes of Health
Stroke Scale (NIHSS), within 72 h of neurological sign onset, in 1-month follow-up period. We assessed NIHSS as primary and plasma levels of TNF-α, IL-1α, IL-1β,
IL-2,
IL-4,
IL-6,
IL-8,
IL-10, IL-12p70, IFN-γ, IP-10, MCP-1,
8-isoprostane, and
PGE2 as secondary outcomes. According to NIHSS evaluation, patients who were allocated to BA group had a significant recovery in neurological function during the 1-month follow-up, compared with the placebo. The levels of plasma inflammatory markers were significantly decreased in BA group after 7 days of intervention in TNF-α, IL-1β,
IL-6,
IL-8, and
PGE2. As a preliminary controlled trial in
ischaemic stroke, BAs could improve clinical outcome in the early phases of
stroke along with promising changes in plasma inflammatory factors.Clinical trial registrationhttps://www.irct.ir Unique identifier: IRCT20170315033086N5. IRCT is a primary registry in the WHO registry network (https://www.who.int/ictrp/network/primary/en/).