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. 2022 Aug;42(4):604-610.
doi: 10.19852/j.cnki.jtcm.20220617.003.

Efficacy and safety of a sequential treatment with clearing heat and eliminating phlegm and tonifying and activating blood circulation in treating acute ischemic stroke: study protocol for a randomized controlled trial

Zhou Ziyi  1   2 , Wan Can  3 , Zhao Yuanqi  3 , Liu Xiangzhe  4 , Gao Ying  5 , A N Hongwei  6 , L I Lejun  7 , Zhang Huili  8 , Y U Xiaofei  9 , Zhang Xinchun  3 , Wang Huijuan  10 , Shi Qing  11 , Wei Chunhua  12 , Chen Jie  13 , Huang Wenguo  14 , Chen Junbin  15 , Gao Ying  5   16 , H U Mingzhe  17 , Cai Yefeng  3
Affiliations

Efficacy and safety of a sequential treatment with clearing heat and eliminating phlegm and tonifying and activating blood circulation in treating acute ischemic stroke: study protocol for a randomized controlled trial

Zhou Ziyi et al. J Tradit Chin Med. 2022 Aug.

Abstract

Objective: To investigate the short-term efficacy and safety outcomes following a sequential treatment with clearing heat and eliminating phlegm (CHEP) formula and tonifying Qi and activating blood circulation (TQABC) formula in patients with acute ischemic stroke (AIS) within a 72 h time window.

Methods: In this randomized, multicenter, double-blinded, placebo-controlled trial, 500 participants will be randomly assigned in a ratio of 1∶1 to the CHEP+ TQABC group or control group. In addition to guideline-based standard medical care, participants in the treatment group will receive the CHEP formula for the first 5 consecutive days followed by the TQABC formula for another 10 consecutive days, while those in the control group will receive CHEP formula placebo and TQABC formula placebo consecutively. The primary outcome measure will be the comparison of the change in the National Institutes of Health Stroke Scale score from baseline to 15 days after randomization. The secondary outcome measures will include the scores on the modified Rankin Scale, Barthel Index, Patient-Reported Outcomes, TCM symptom pattern (Zheng-hou) evaluation Scale, and the incidence of in-hospital complications. Safety assessment will include the physical examination, laboratory detection, any adverse events or serious adverse events, and the proportion of any complications during hospitalization.

Discussion: The results of this study will provide objective and scientific data with which to assess the efficacy and safety of a sequential treatment based on "integrating disease and symptom pattern" for patients with AIS.

Keywords: clearing heat and eliminating phlegm; clinical protocols; randomized controlled trial; stroke; tonifying and activating blood circulation.

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Figures

Figure 1
Figure 1. Trial flow chart
CHEP: clearing heat and eliminating phlegm; TQABC: tonifying Qi and activating blood circulation.
See this image and copyright information in PMC

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