scholarly journals Yiqi Fumai Injection for patients with Septic Shock: study protocol for a randomized controlled trial1

2020 ◽  
Author(s):  
jing zeng ◽  
Hai-rong Cai ◽  
Shu-ling Liu ◽  
Shuai Zhao ◽  
Zhi-shang Li ◽  
...  
Keyword(s):  
Septic Shock ◽  
Conventional Treatment ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Randomized Controlled

Abstract Background Septic shock is an important problem in critical care medicine and one of the leading causes of death in intensive care units (ICU). In China, Traditional Chinese medicine ( TCM) has been widely used as the adjuvant treatment to improve the symptoms and prognosis in patients with septic shock. Yiqi Fumai Injection (YFI) is one of the most important proprietary TCM for septic shock, previous studies have demonstrated its efficacy and safety. However, these conclusions were limited due to the small sample size and low quality of methodologies of these studies. Therefore, we designed this study to evaluate the efficacy and safety of using YFI as an adjunct treatment for septic shock.Methods This is a double-blind, randomized, parallel, placebo-controlled clinical trial. A total of 800 participants will be randomly assigned to receive either treatment or placebo in a 1:1 ratio. The treatment group will receive YFI combined with conventional treatment, and the control group will receive 0.9% sodium chloride injection combined with conventional treatment for 2 weeks. The primary outcome is the 28- days mortality. Secondary outcomes are blood lactate levels, hemodynamics , blood gas analysis, immune function indicators, inflammatory indicators, acute physiology improvement and chronic health assessment (APACHE) II scores, and sepsis-related organ failure score (SOFA). Adverse events will be observed and recorded at the same time for safety assessment.Discussion This randomized controlled trial will help evaluate the efficacy and safety of YFI for the treatment of septic shock. The results of this trial will provide recommendations for the management of septic shock.

scholarly journals Yiqi Fumai Injection for patients with Septic Shock: study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Bo-jun Chen ◽  
Zeng Jing ◽  
Cai Xingui ◽  
Cai Hairong ◽  
Luo Sicong ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Septic Shock ◽  
Randomized Controlled Trial ◽  
Conventional Treatment ◽  
Controlled Trial ◽  
Small Sample ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Abstract Background: Septic shock is an important problem in critical care medicine and one of the leading causes of death in intensive care units (ICU). In China, Traditional Chinese medicine (TCM) has been widely used as the adjuvant treatment to improve the symptoms and prognosis in patients with septic shock. Yiqi Fumai Injection (YFI) is one of the most important proprietary TCM for septic shock, previous studies have demonstrated its efficacy and safety. However, these conclusions were limited due to the small sample size and low quality of methodologies of these studies. Therefore, we designed this study to evaluate the efficacy and safety of using YFI as an adjunct treatment for septic shock.Methods/design: This is a double-blind, randomized, parallel, placebo-controlled clinical trial. A total of 800 participants will be randomly assigned to receive either treatment or placebo in a 1:1 ratio. The treatment group will receive YFI combined with conventional treatment, and the control group will receive 0.9% sodium chloride injection combined with conventional treatment for 2 weeks. The primary outcome is the 28-days mortality. Secondary outcomes are blood lactate levels, hemodynamics, blood gas analysis, immune function indicators, inflammatory indicators, acute physiology improvement and chronic health assessment (APACHE) II scores, and sepsis-related organ failure score (SOFA). Adverse events will be observed and recorded at the same time for safety assessment.Discussion: This randomized controlled trial will help evaluate the efficacy and safety of YFI for the treatment of septic shock. The results of this trial will provide recommendations for the management of septic shock.Trial registration {2a and 2b}：China Clinical Trial Registry, ChiCTR-1900026424.Registered on 15 June 2019.

scholarly journals Efficacy and safety of Guhong injection for treating the Coronary microvascular disease: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Jieqin Zhuang ◽  
Shuling Liu ◽  
Hairong Cai ◽  
Xingzhen Dai ◽  
Yanhong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cardiovascular Diseases ◽  
Controlled Trial ◽  
Microvascular Disease ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Randomized Controlled

Abstract Background: Coronary microvascular disease (CMVD) refers to cardiovascular diseases with normal coronary angiography but evidence of myocardial ischemia or microcirculation lesions, often presenting as angina pectoris attack. Coronary artery of microtubules dysfunction is one of the pathogenesis of coronary heart disease,but the occurrence and development and the current of CMVD intervention therapy remains to be further researched.Chinese traditional medicine (TCM)has advantages in the treatment of cardiovascular diseases, therefore, this article describes an ongoing randomized controlled clinical trial, based on the theory of TCM, for the purpose of evaluating the efficacy and safety of Guhong injection ,a Chinese patent medicine,compared with placebo in patients suffering from CMVD. Methods/design: This is a multicenter, randomized, parallel arm, open-label, double-blind, placebo-controlled clinical trial. A total of 260 eligible patients will be allocated and randomly assigned, in a ratio of 1:1, to either the experimental group or the control group. The treatment course is 10 consecutive days, with a 8-week follow-up. The primary outcome is the frequency of angina attacks, Secondary outcomes include myocardial metabolites, ecg changes, quantitative score of TCM syndromes, inflammatory response and endothelial function indicators. Discussion: This trial is strictly designed in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide high quality evidence on the efficacy and safety of Guhong injection in the treatment of CMVD. Trial registration: Chinese Clinical Trials Registry, ChiCTR1900022902. Registered on 27 April 2019.

scholarly journals Baidu Jieduan granule, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial

2020 ◽  
Author(s):  
Wen Zhang ◽  
Qin Xie ◽  
Xiaoming Xu ◽  
Shuting Sun ◽  
Tian Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
Theory And Practice ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granule in treatment of moderate COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

scholarly journals Efficacy and Safety of Dahuang Zhechong Pill in Silicosis: A Randomized Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Wu-Yi-Nuo Tang ◽  
Jing-Tao Liang ◽  
Ju Wu ◽  
Li Liu ◽  
Ming-Zhang Lu ◽  
...  
Keyword(s):  
Treatment Group ◽  
Pulmonary Function ◽  
Conventional Treatment ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Conventional Treatment Group ◽  
Randomized Controlled ◽  
Safety Outcomes ◽  
Medicine Prescription

Background. There is no effective therapy for silicosis, and Dahuang Zhechong pill (DHZCP), an ancient Chinese medicine prescription, may have a therapeutic effect on silicosis. This study aims to verify the efficacy and safety of DHZCP in silicosis. Methods. This is a randomized controlled clinical trial done at Panzhihua Second People’s Hospital (Panzhihua City, Sichuan Province, China). Participants diagnosed with silicosis were recruited and randomized to the conventional treatment group (CG) or DHZCP combined with the conventional treatment group (DG). Forced vital capacity % predicted (FVC%), diffusing capacity of the lung for carbon monoxide % predicted (DLCO%), six-minute walk distance (6MWD), peripheral oxygen (SpO2), King’s Brief Interstitial Lung Disease Questionnaire (K-BILD), and safety outcomes were measured at baseline and 9 weeks. Results. Fifty-six participants (28 in each group) completed the study, and 53 of them (26 in DG and 27 in CG) completed pulmonary function. At 9 weeks, compared with no DHZCP, DHZCP treatment was associated with significant improvements in FVC% (mean ± SD, 95%CI) (8.2 ± 3.9, 0.3 to 16.0), DLCO% (8.6 ± 3.5, 1.5 to 15.7), SpO2 (3.8 ± 0.7, 2.3 to 5.2), and K-BILD total score (6.0 ± 2.3, 1.4 to 10.7). And, there were no statistical differences of safety outcomes between the two groups. Eight patients accepting DHZCP developed mild diarrhea during the first week, which subsequently resolved on its own. Conclusion. DHZCP could improve the pulmonary function, the quality of life, and the exercise capacity of silicosis patients.

scholarly journals Baidu Jieduan granules, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label, randomized controlled clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Wen Zhang ◽  
Qin Xie ◽  
Xiaoming Xu ◽  
Shuting Sun ◽  
Tian Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
Theory And Practice ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Background Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive effects on human health. Due to the absence of antiviral medicine for COVID-19 thus far, there is a desperate need to develop effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, with the aim of achieving clinical efficacy and decreasing the use of antibiotics and glucocorticoids. The aim of this study was to evaluate the efficacy and safety of Baidu Jieduan granules in treating COVID-19. Methods/design This multicentre, open-label, randomized controlled trial will be conducted in 300 patients with COVID-19. The patients will be randomly (1:1) divided into a treatment group and a control group. All patients will receive standard therapy at the same time. Patients in the experimental group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes will be assessed at baseline and at 3, 5, 7 and 14 days after treatment initiation. The primary outcome will be the rate of symptom (fever, fatigue and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial. Discussion The study will provide high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granules in the treatment of moderate COVID-19, and enrich the theory and practice of TCM in treating COVID-19. Trial registration Chinese Clinical Trial Registry ChiCTR2000029869. Registered on 15 February 2020

scholarly journals Baidu Jieduan Granule in the Treatment of Coronavirus Disease-2019 (COVID-19): Study Protocol for an Open-Label Randomized Controlled Clinical Trial

2020 ◽  
Author(s):  
Wen Zhang ◽  
Qin Xie ◽  
Xiaoming Xu ◽  
Shuting Sun ◽  
Tian Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Theory And Practice ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Randomized Controlled ◽  
Epidemic Diseases

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan Granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan Granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan Granule in treatment of severe COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

scholarly journals Comparing Effectiveness of HRV-Biofeedback and Mindfulness for Workplace Stress Reduction: A Randomized Controlled Trial

2020 ◽  
Vol 45 (4) ◽  
pp. 307-322
Author(s):  
Amelie Edith Brinkmann ◽  
Sophia Antonia Press ◽  
Eduard Helmert ◽  
Martin Hautzinger ◽  
Inna Khazan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stress Reduction ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Workplace Stress ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Randomized Controlled

Abstract Psychophysiological disorders due to work-related stress continue to be highly costly for health systems and approaches for cost-effective and easily accessible interventions are much needed. Both heart rate variability-biofeedback (HRV-Bfb) and mindfulness-based interventions (MBI) have been empirically shown to reduce stress. This study compares these two interventions in the work context to a wait-list-control-group (WLC). In this three-armed randomized controlled trial (RCT), 69 healthy adults employed in the same organization were randomized to participate in HRV-Bfb, MBI or the WLC. Participants were assessed for psychophysiological parameters of stress (stress perception, coping, HRV parameters and cortisol) and stress related symptoms (depressive symptoms, psychological wellbeing, mindfulness and self-compassion). Participants trained using either HRV-Bfb or MBI for 6 weeks on a daily basis. Outcomes were assessed at baseline, after the intervention and at follow-up 12 weeks later. Results did not show any statistically significant differences between HRV-Bfb and MBI groups, and neither of the intervention groups (IGs) differed from the WLC. Findings suggest an overall reduction in stress for all groups, including the WLC, with mostly small to medium effect sizes. However, it is important to note that participants with higher baseline stress levels might benefit more from mindfulness and biofeedback-based stress reduction interventions. The results have to be interpreted with caution due to the relatively small sample size. MBI might have a slightly stronger effect on stress reduction in comparison to HRV-Bfb, as suggested by the effect sizes. This study highlights issues and challenges of the implementation of such interventions in corporate health management.

scholarly journals The Efficacy and Safety of Longmu Tang Granule for Treating Atopic Dermatitis: Study Protocol for a Single-Centered, Double-Blinded, Randomized Controlled Trial

2021 ◽  
Author(s):  
YAQIN LI ◽  
TAOTAO SHEN ◽  
QINGYING WANG ◽  
MENGXI MA ◽  
FENGYAN TIAN ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Atopic Dermatitis ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Randomized Controlled ◽  
Limited Effectiveness

Abstract Background: Atopic dermatitis (AD) is a chronic relapsing skin disease that has long-term adverse effects on the physical and mental health of children. Current treatments mainly include anti-inflammatory, antibacterial, and anti-allergic interventions, systemic therapy and recently emerging targeted agents. However, these treatments have limited effectiveness and bothersome side effects. The use of traditional Chinese medicine (TCM) is associated with safety and improvements in the clinical symptoms and quality of life of AD patients. However, the poor quality and heterogeneity of studies have not led to sufficient conclusions. Therefore, we will conduct a randomized, controlled, double-blind clinical trial to confirm the efficacy and safety of Longmu Tang granule for the treatment of AD.Methods: This is a single-center, double-blind, randomized, controlled clinical trial. A total of 60 participants will be randomly assigned (1:1) to receive Longmu Tang granule or placebo granule for 8 weeks. The primary outcome is the index of Scoring Atopic Dermatitis (SCORAD). The second outcomes include the children's Dermatology Life Quality Index (CDLQI) and the Number Cancel Test (NCT), and long-term efficacy. Mechanistic outcome is the serum level of inflammatory cytokines, including IgE, tumor necrosis factor (TNF) -α, interleukin-1 (IL-1) and interleukin-6 (IL-6).Discussion: The results of this trial will provide evidence on the efficacy and safety of Longmu Tang granule and prove anti-inflammation of Longmu Tang granule for patients with AD.Trial registration: Chinese Clinical Trial Registry Chictr.org ID: ChiCTR2100041591. Registered on 1 January 2021. https://www.chictr.org.cn/showproj.aspx?proj=62586

scholarly journals The Effect of Kinesiology Taping on the Hemiplegic Shoulder Pain: A Randomized Controlled Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Lin Yang ◽  
Jingyi Yang ◽  
Chengqi He
Keyword(s):  
Pain Intensity ◽  
Shoulder Pain ◽  
Muscle Activity ◽  
Conventional Treatment ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Range Of Movement ◽  
Double Blind

Objective. The purpose of the study was to explore the effect of kinesiology taping on hemiplegic shoulder pain (HSP) in terms of pain intensity, magnitude of subluxation, muscle activity, and active range of motion (AROM). Design. Double-blind, placebo-controlled clinical trial. Setting. the Rehabilitation Center of the West China Hospital. Participants. Nineteen individuals suffering from HSP were recruited in this study. Intervention. Patients were randomly assigned into the taping group or control group. The taping group received therapeutic kinesiology taping and conventional treatment, while the control group received placebo taping (applied without tension) and conventional treatment. Main Outcome Measures. The shoulder pain intensity (numerical pain rating scale), magnitude of subluxation, muscle activity (measured by surface electromyography (sEMG)), and shoulder active range of movement (AROM) were assessed at the baseline, on the first day (immediately after taping) and 4 weeks after treatment (without taping). Results. All patients completed the trials. There were no significant differences between groups at the baseline. The taping group showed immediate improvement on the first day after taping in terms of pain intensity, magnitude of subluxation, and muscle activity (p<0.05), whereas no significant changes seen in the control group (p>0.05). After 4 weeks of treatment, the taping group showed significant changes in pain intensity, magnitude of subluxation, muscle activity, and AROM (p<0.05). And significant differences in pain intensity and muscle activity could be seen between the two groups (p<0.05). Conclusion. The results indicate that the kinesiology taping is effective in reducing the shoulder pain and subluxation and increasing muscle activity and AROM for patients with HSP after stroke.

scholarly journals Evaluation on immediate analgesic efficacy and safety of Kai-Hou-Jian spray (children’s type) in treating sore throat caused by acute pharyngitis and tonsillitis in children: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yan-ning Ma ◽  
Cheng-liang Zhong ◽  
Si-yuan Hu ◽  
Qiu-han Cai ◽  
Sheng-xuan Guo
Keyword(s):  
Clinical Trial ◽  
Sore Throat ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Effective Rate ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acute Pharyngitis ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Background Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients’ quality of life. However, there is no proven effective or safe method to treat it. It is necessary to find an excellent strategy to reduce sore throat and reduce the burden of acute illness. We designed the randomized controlled trial with the characteristics of traditional Chinese medicine (TCM) to determine the clinical positioning of Kai-Hou-Jian spray (children’s type) (KHJS) through evidence-based research. This trial aims to evaluate the immediate analgesic efficacy of KHJS on sore throat caused by acute pharyngitis and tonsillitis (wind-heat syndrome/heat exuberance in lung and stomach syndrome) in children and to observe its safety. Methods/design This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. It will include 240 children with acute pharyngitis/tonsillitis from 7 study sites across China. All participants are randomly assigned to two parallel treatment groups, one with KHJS and the other with placebo sprays, for 5 consecutive days. The primary outcome is the time of analgesic onset. Secondary outcomes include duration of analgesic effect, area under time curve of 0–3 h Wong-Baker FACES Pain Rating Scale (WBS) score (AUC0-3 h), rate of analgesic onset, rate of disappearance of sore throat, changes of WBS score (in days), effective rate of pharyngeal signs, and effective rate of TCM syndrome. The incidence of adverse events during the trial is the primary safety outcome. In addition, vital signs and laboratory tests before and after medication are monitored. Discussion To our knowledge, this will be the first clinical trial to explore the immediate analgesic efficacy of a Chinese patent medicine spray for acute pharyngitis/tonsillitis induced sore throat in children in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it prove the efficacy and safety of KHJS in the treatment of sore throat caused by acute pharyngitis/tonsillitis in children, but it might also provide evidence for the treatment of acute sore throat with Chinese herbal medicine. Trial registration A multicenter, randomized, double-blind, very low-dose, parallel controlled trial for the immediate analgesic effect and safety of Kai-Hou- Jian spray (children's type) in the treatment of sore throat caused by acute pharyngitis and tonsillitis in children. Chinese Clinical Trial Registry ChiCTR2000031599. Registered on 5 April 2020

Sign in / Sign up

Export Citation Format

Share Document