scholarly journals 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 ◽  
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.

scholarly journals Xiao Zheng San Jie Granules in the Treatment of Qi Deficiency and Blood Stasis Syndrome in Patients With Diabetic Kidney Disease Stage IV: Protocol for a Randomised, Double-blind, Placebo-controlled, Multi-centre Trial

2021 ◽  
Author(s):  
Sinan Ai ◽  
Yizhen Han ◽  
Yabin Gao ◽  
Yaoxian Wang ◽  
Jingwei Zhou ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Blood Stasis ◽  
Stage Iv ◽  
Blood Stasis Syndrome ◽  
Disease Stage ◽  
Double Blind ◽  
Diabetic Kidney ◽  
Double Blind Placebo

Abstract Introduction Diabetic kidney disease (DKD) is a major microvascular complication of diabetes mellitus (DM) and the primary cause of end-stage renal disease. Routine medication might result in adverse effects which limit their usage. Laboratory studies have shown that Xiao Zheng San Jie (XZSJ) granules is effective in reducing the levels of urinary protein and blood creatinine in rats with DKD. Hence, we aim to conduct a clinical trial to determine the efficacy and safety of XZSJ granules among patients with DKD Stage IV, who present with the syndromes of qi deficiency and blood stasis. The purpose of this paper is to report the methodology of this trial.Methods and analysisThis is a randomised, double-blind, placebo-controlled, multi-centre clinical trial. A total of 72 patients with DKD Stage IV who have the syndromes of qi deficiency and blood stasis will be randomly assigned to either intervention or placebo group. In addition to routine medication, the intervention group will be given XZSJ formula (in granules) and the control group will be given placebo for 12-weeks. Data collected at baseline as well as weeks 4, 8 and 12 will be recorded in case report forms and subsequently entered into EpiData 3.1 electronic database. Adverse events will also be documented. Primary outcomes – estimated glomerular filtration rate, urinary albumin-to-creatinine ratio, and serum creatinine – will be assessed after 12 weeks. Ethics and disseminationThis trial has been approved by the Research Ethics Committee of Dongzhimen Hospital (DZMEC-KY-2018-60). Informed consent will be obtained from all participants. Results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.DiscussionThis trial might provide information on an effective method for the treatment of DKD, especially for patients who present with the syndromes of qi deficiency and blood stasis. We hope that this trial will serve as a reference for the conception of high-quality Traditional Chinese Medicine trials in the future, which incorporate syndrome diagnosis into the study design.Trial registration Chinese Clinical Trial Registry, ChiCTR1900021391. Registered 18 February 2018, http://www.chictr.org.cn/showproj.aspx?proj=36106.

scholarly journals Efficacy and safety of Xinnaoning capsule in treating chronic stable angina (qi stagnation and blood stasis syndrome)

Medicine ◽  
2019 ◽  
Vol 98 (31) ◽  
pp. e16539 ◽  
Author(s):  
Jun-Nan Zhao ◽  
Ying Zhang ◽  
Xu Lan ◽  
Yao Chen ◽  
Jing Li ◽  
...  
Keyword(s):  
Stable Angina ◽  
Blood Stasis ◽  
Chronic Stable Angina ◽  
Blood Stasis Syndrome ◽  
Efficacy And Safety ◽  
Qi Stagnation

Enoximone in Chronic Stable Angina: A Double-Blind Placebo-Controlled Cross-Over Trial

1994 ◽  
Vol 23 (4) ◽  
pp. 532-538 ◽  
Author(s):  
Simon W. Dubrey ◽  
Ari Gnanasakthy ◽  
Wendy K. Stein ◽  
Jie G. Song ◽  
Timothy Hardman ◽  
...  
Keyword(s):  
Stable Angina ◽  
Chronic Stable Angina ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals rs5911 and rs3842788 Genetic Polymorphism, Blood Stasis Syndrome, and Plasma TXB2 and hs-CRP Levels Are Associated with Aspirin Resistance in Chinese Chronic Stable Angina Patients

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Mei Xue ◽  
Xuesong Yang ◽  
Lin Yang ◽  
Na Kou ◽  
Yu Miao ◽  
...  
Keyword(s):  
Genetic Markers ◽  
Stable Angina ◽  
Blood Stasis ◽  
Chronic Stable Angina ◽  
Aspirin Resistance ◽  
Light Transmittance ◽  
Blood Stasis Syndrome ◽  
Hs Crp ◽  
The Impact ◽  
Txb2 Level

The identification of single nucleotide polymorphisms (SNPs) related to aspirin resistance (AR) is of great significance for the explanation why some individuals demonstrate an incomplete response to aspirin and for optimizing the antiplatelet therapy strategy. The study was designed to investigate the possible associated genetic markers and clinical factors of AR for Chinese patients with chronic stable angina after PCI and to analyze the association between TXA2, PGI2, hs-CRP level, AR, and gene polymorphisms. Totally 207 chronic stable angina patients who received 100 mg maintenance dose daily of aspirin for more than 7 days were enrolled. The inhibition of platelets was assessed using light transmittance aggregometry. TXB2, 6-keto-PGF1α, and hs-CRP were measured by radioimmunoassay. Genotyping was performed using Taqman probe technique (rs5787 and rs5911) and gene sequencing technology (rs3842788). By using binary logistic regression analysis, the impact of clinical and genetic determinants on AR was evaluated. The prevalence of AR and aspirin semiresistance (ASR) was 3.86% and 20.76%, respectively, in Chinese chronic stable angina patients. rs5911 A/C and C/C versus A/A genotype (OR = 5.546, 95% CI = 1.812–11.404), rs3842788 A/G versus G/G genotype (OR = 8.358, 95% CI = 2.470–28.286), and blood stasis syndrome (BSS, OR = 10.220, 95% CI = 4.242–24.621) were associated with AR, but rs5787 variants were all homozygous of G/G genotype. Plasma TXB2 and hs-CRP increased significantly in AR and ASR group, while 6-keto-PGF1αshowed no difference, and TXB2 level was significantly higher in carriers of the rs3842788 A/G genotype. According to our results, rs5911 and rs3842788 are proved to be specific genetic markers of AR in Chinese chronic stable angina patients for the first time, and BSS was also proved to be a remarkable determinant for AR. The AR and ASR patients were with increased plasma TXB2 and hs-CRP levels, and the TXB2 level was influenced by the variation of rs3842788 genotype.

Enoximone in Chronic Stable Angina: A Double-Blind Placebo-Controlled Crossover Trial

1993 ◽  
Vol 84 (s28) ◽  
pp. 22P-22P
Author(s):  
S Dubrey ◽  
J Song ◽  
T Hardman ◽  
J Hynd ◽  
N Grainger ◽  
...  
Keyword(s):  
Stable Angina ◽  
Crossover Trial ◽  
Chronic Stable Angina ◽  
Double Blind ◽  
Double Blind Placebo
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