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

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

10.21203/rs.3.rs-44542/v2 ◽

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

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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 ◽

10.1186/s13063-021-05418-y ◽

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

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

10.21203/rs.3.rs-44542/v1 ◽

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

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

10.21203/rs.2.13551/v2 ◽

2019 ◽

Author(s):

Jieqin Zhuang ◽

Shuling Liu ◽

Hairong Cai ◽

Xingzhen Dai ◽

Yanhong Chen ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Controlled Trial ◽

Cardiovascular Diseases ◽

Inflammatory Response ◽

Endothelial Function ◽

Controlled Trial ◽

Microvascular Disease ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

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. Keywords: Guhong injection, Coronary microvascular disease, randomized controlled trial, inflammatory response,endothelial function

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

10.21203/rs.3.rs-414387/v1 ◽

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.

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

10.21203/rs.2.21820/v1 ◽

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.

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

10.21203/rs.3.rs-800853/v1 ◽

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

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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 ◽

10.1186/s13063-021-05148-1 ◽

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

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Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

BMC Musculoskeletal Disorders ◽

10.1186/s12891-021-04168-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Shicheng Wang ◽

Wensheng Wang ◽

Long Shao ◽

Jing Ling

Keyword(s):

Clinical Trial ◽

Total Knee Arthroplasty ◽

Randomized Controlled Trial ◽

Pain Control ◽

Controlled Trial ◽

Control Group ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Total Knee ◽

Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

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Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽

10.1136/bmjopen-2020-041958 ◽

2020 ◽

Vol 10 (10) ◽

pp. e041958

Author(s):

Nirmani Yasara ◽

Nethmi Wickramarathne ◽

Chamila Mettananda ◽

Aresha Manamperi ◽

Anuja Premawardhena ◽

...

Keyword(s):

Clinical Trial ◽

Sri Lanka ◽

Intervention Group ◽

Primary Outcome Measure ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Scientific Publications ◽

Double Blind ◽

Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

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