Application and Prospect of Platelet Multi-Omics Technology in Study of Blood Stasis Syndrome

Abstract Background Hemiplegia is a common sequela after stroke, and acupuncture is one of the most common physical therapies used to treat hemiplegia during the recovery stage after ischaemic stroke. ‘Hand and foot acupuncture with twelve needles’ is an acupuncture treatment performed after stroke. The principal objective of this study is to assess the efficacy and safety of ‘hand and foot acupuncture with twelve needles’ for hemiplegia in the convalescent stage of ischaemic stroke. Methods This is the protocol for a randomised, controlled clinical trial with two groups: a ‘hand and foot acupuncture with twelve needles’ group and a routine acupuncture group. A total of 208 participants will be randomly assigned to two different groups in a 1:1 ratio and will undergo conventional rehabilitation. Limb function will be evaluated by the simplified Fugl-Meyer assessment scale, Barthel Index, modified Ashworth scale and National Institute of Health stroke scale. The participants will be evaluated at baseline (on the day of enrolment) and followed up at 2 weeks, 1 month, 2 months and 3 months after enrolment. Discussion The results of this study will provide evidence on the effectiveness of ‘hand and foot acupuncture with twelve needles’ in the treatment of limb dysfunction that can be used for future evaluations. Trial registration Chictr.org.cnChiCTR1900021774. Registered on 8 March 2019

Download Full-text

Efficacy and safety of Suxiao Jiuxin Pill in the treatment of stable angina (Qi stagnation and blood stasis syndrome): study protocol of a randomized, double-blind, placebo-controlled, multi-center clinical trial

Trials ◽

10.1186/s13063-021-05448-6 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Xiaofen Ruan ◽

Yiping Li ◽

Yuanlong Sun ◽

Meijun Jia ◽

Xiaowen Xu ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Research ◽

Stable Angina ◽

Conventional Therapy ◽

Blood Stasis ◽

Chronic Stable Angina ◽

Blood Stasis Syndrome ◽

Double Blind ◽

Double Blind Placebo ◽

Qi Stagnation

Abstract Background Coronary heart disease (CHD) has become one of the biggest health problems in the world. Stable angina is a common clinical type of CHD with poor prognosis and high mortality. Although there are various interventions for stable angina, none of them can significantly reduce mortality. Both basic and clinical research have shown that Suxiao Jiuxin Pill (SJP) can relieve the symptoms of angina pectoris and improve the clinical efficacy, but there is a lack of high-quality clinical research to provide research-based evidence. We design a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of SJP for stable angina. Methods/design This is a prospective, randomized, double-blind, placebo-controlled, and multicenter trial. The trial will enroll 324 participants with chronic stable angina (Qi Stagnation and Blood Stasis syndrome). All participants will have received the conventional therapy of chronic stable angina. Participants will be randomized into two groups, conventional therapy plus SJP group and conventional therapy plus placebo group. Eligible participants will receive either SJP or placebo (five pills administered orally, three times daily) in addition to conventional treatment for 24 weeks. The primary outcomes are the symptom improvement rate of angina from baseline to 4 weeks after inclusion and major adverse cardiovascular events (MACE). The secondary outcomes are angina classification (CCS), improvement of traditional Chinese medicine (TCM) syndromes, Seattle Angina Scale score, the dosage of emergency drugs and the stopping rate, and electrocardiogram (EKG) efficacy. Adverse events will be monitored throughout the trial. Discussion Integrated traditional Chinese and Western Medicine is commonly used for angina in China. This study will evaluate the clinical effectiveness and safety of SJP for angina. The results of the trial will provide high-level clinical research-based evidence for the application of SJP instable angina. Trial registration This study protocol was registered on 14 March 2019. The registration number is ChiCTR1900021876 on the Chinese Clinical Trial Registry.

Download Full-text