Efficacy and safety of fire needle therapy for blood stasis syndrome of plaque psoriasis: protocol for a randomized, single-blind, multicenter clinical trial

Neurofibromatosis type 2 (NF2) causes bilateral vestibular schwannomas (VSs), leading to deafness. VS is treated by surgery or radiation, but neither treatments prevent hearing loss. Bevacizumab was found to be effective in suppressing the tumor’s growth and may help to improve hearing. We are conducting a randomized, double-blind, multicenter clinical trial to verify the efficacy and safety of bevacizumab in NF2-related VS. The primary objective is to evaluate the efficacy of bevacizumab in improving hearing in the affected ear. One of the secondary objectives is to evaluate bevacizumab’s efficacy in rechallenge treatment in relapsed cases. Sixty patients will randomly receive either bevacizumab or a placebo and will be clinically observed for 48 weeks in the initial intervention phase. In the first half (24 weeks), they will receive either 5 mg/kg of bevacizumab or a placebo drug. In the second half, all patients will receive 5 mg/kg of bevacizumab. If hearing function deteriorated in a patient who had shown improvement during the first phase, a rechallenge dose with bevacizumab would be offered.

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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.

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The Immediate And Long-Term Effects of Shexiang Tongxin Dropping Pill On Coronary Slow Flow: Study Protocol For A Randomized Double-Blind Placebo-Controlled Trial

10.21203/rs.3.rs-467743/v1 ◽

2021 ◽

Author(s):

Birong Liu ◽

Yong Liu ◽

Liyong Ma ◽

Jia Liu ◽

Jingen Li ◽

...

Keyword(s):

Clinical Trial ◽

Blood Flow ◽

Blood Stasis ◽

Blood Stasis Syndrome ◽

Controlled Study ◽

Slow Flow ◽

Long Term Effects ◽

Coagulation Function ◽

Coronary Slow Flow

Abstract Background: Coronary slow flow (CSF) is a phenomenon characterized by delayed contrast medium progression in angiography in the absence of obstructive coronary epicardial disease. However, there is currently no definite effective therapy. A small sample self-controlled study had suggested an immediate improvement in coronary slow blood flow by Shexiang Tongxin Dropping Pills (STDP). But high-quality evidences on drug dosage, medication cycle and long-term effects are still lacking while the mechanism of STDP remains unclear. Methods: This study is a randomized, double-blinded, and placebo-controlled clinical trial. A total of 64 CSF patients diagnosed by coronary angiography will be randomly allocated into the test group, using STDP, and the control group, using placebo. The main efficacy indicators for immediate effects include thrombolysis in myocardial infarction (TIMI) blood flow grading and corrected TIMI frame count. Long-term effects will be evaluated by the comparison of cardiac radionuclide score, and patient condition such as angina readmission rate and angina scale. The safety indicators include a routine complete blood count, liver and renal function test, cardiac markers (including TnI, CK-MB, Myo), NT-proBNP, coagulation function, 12-lead electrocardiogram, and echocardiography. All adverse events during the trial will be recorded. Moreover, endothelial factors (including ET-1, NO, eNOS, iNOS), inflammatory factors (including adropin, IL-6, IL-1, IL-18, TNF-α, Lp-PLA2, hs-CRP) will be observed. Blood stasis syndrome (including platelet activation factors such as CD62 and CD63, coagulation function and blood stasis syndrome score) will be evaluated.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000035167. Registered on August 2, 2020. http://www.chictr.org.cn/showproj.aspx?proj=57349

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