Efficacy and Safety of Jiannao Tongluo Granules in the Treatment of Convalescent Cerebral Infarction: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial

Abstract

Objective

This study aimed to investigate the efficacy and safety of Jiannao Tongluo (JNTL) granules in patients with convalescent cerebral infarction and to explore the underlying mechanisms.

Methods

A randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted from November 2024 to November 2025. A total of 110 eligible patients were randomly assigned at a 1:1 ratio to receive either JNTL granules or placebo control for 12 weeks on the basis of standard secondary prevention and comprehensive rehabilitation. The primary outcome was the variation in the Montreal Cognitive Assessment (MoCA) score. The secondary outcomes included the Vascular Dementia Assessment Scale-Cognitive Subscale (VaDAS-cog), Mini-Mental State Examination (MMSE), Fugl-Meyer Assessment (FMA), modified Barthel index (MBI), and TCM symptom score (SYM), which were measured at baseline and at weeks 4, 12, and 24. Serum inflammatory factors (hs-CRP, IL-6, IL-1β, TNF-α, and SAA) and neurotrophic factors (BDNF and VEGF) were measured at baseline and week 12. The activation of the cerebral cortex was evaluated by functional near-infrared spectroscopy (fNIRS) at baseline and week 12. Safety was monitored throughout the trial.

Results

A total of 97 patients (48 in the JNTL granule group and 49 in the control group) completed the trial, for a dropout rate of 11.8%. Baseline characteristics were well balanced between the groups (all P > 0.05). At 12 and 24 weeks, the JNTL granule group showed more substantial increases in the MoCA, MMSE, FMA, and MBI scores and lower VaDAS-cog and SYM scores than the control group (all P < 0.05). At week 12, compared with the control treatment, JNTL granules treatment significantly reduced serum levels of hs-CRP, IL-6, IL-1β, TNF-α, and SAA, and increased serum BDNF and VEGF levels (all P < 0.05). fNIRS revealed that the JNTL granules significantly enhanced task-evoked HbO activation in the temporal cortex (TC), Broca’s area, and premotor and supplementary motor cortex (PreM/SMC) (all P < 0.05). There were no reports of serious adverse events.

Conclusion

JNTL granules effectively improve cognitive function, motor function, and activities of daily living (ADL) in patients with convalescent cerebral infarction of wind-phlegm obstructing collateral syndrome, with durable efficacy and favorable safety. The mechanisms may involve the suppression of excessive inflammatory responses, the promotion of neuroprotection and angiogenesis, and the enhancement of activation in key cognitive-motor-related cortical regions.

Keywords

Jiannao Tongluo granules / Traditional Chinese medicine / Wind-phlegm obstructing collateral syndrome / Convalescent cerebral infarction / Cognitive impairment / Motor function / Functional near-infrared spectroscopy / Randomized controlled trial

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Funding

State Administration of Traditional Chinese Medicine of the People's Republic of China(GZY-KJS-2025-001)

Department of Science and Technology of Hubei Province(2023BEB005)

the Shizhen Talent Program of Hubei Province for Scientific Research(Hubei Health Document [2024] No. 256)

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