scholarly journals Efficacy and safety of berberine for dyslipidemia: study protocol for a randomized double-blind placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ying Zhao ◽  
Yuan-Yuan Yang ◽  
Bao-Lin Yang ◽  
Ya-Wei Du ◽  
Da-Wei Ren ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Density Lipoprotein ◽  
Lipid Lowering ◽  
Controlled Clinical Trial ◽  
Atherosclerotic Cardiovascular Disease ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
High Quality ◽  
Double Blind

Abstract Background Dyslipidemia is a major risk factor for atherosclerotic cardiovascular disease and a leading cause of death worldwide. The clinical utility of commonly used lipid-lowering drugs such as statins and fibrates is sometimes limited by the occurrence of various adverse reactions. Recently, berberine (BBR) has received increasing attention as a safer and more cost-effective option to manage dyslipidemia. Thus, a high-quality randomized controlled trial to evaluate the efficacy and safety of BBR in the treatment of dyslipidemia is deemed necessary. Methods/design This is a randomized, double-blind, and placebo-controlled clinical trial. A total of 118 patients with dyslipidemia will be enrolled in this study and randomized into two groups at a ratio of 1:1. BBR or placebo will be taken orally for 12 weeks. The primary outcome is the percentage of low-density lipoprotein cholesterol reduction at week 12. Other outcome measures include changes in other lipid profiles, high sensitivity C-reactive protein, blood pressure, body weight, Bristol Stool Chart, traditional Chinese medicine symptom form, adipokine profiles, and metagenomics of intestinal microbiota. Safety assessment includes general physical examination, blood and urine routine test, liver and kidney function test, and adverse events. Discussion This trial may provide high-quality evidence on the efficacy and safety of BBR for dyslipidemia. Importantly, the findings of this trial will help to identify patient and disease characteristics that may predict favorable outcomes of treatment with BBR and optimize its indication for clinical use. Trial registration Chinese Clinical Trial Registry ChiCTR1900021361. Registered on 17 February 2019.

scholarly journals Efficacy and Safety of Qushi Huayu Granule For Hyperlipidemia: Study Protocol For a Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Author(s):  
Yuanlong Sun ◽  
Na Hu ◽  
Gaofeng Chen ◽  
Yanjie Wang ◽  
Yiyang Hu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Density Lipoprotein ◽  
Efficacy And Safety ◽  
Efficacy Evaluation ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Alcoholic Fatty Liver ◽  
Double Blind Placebo ◽  
Common Chronic Disease

Abstract Background: Hyperlipidemia has become a common chronic disease worldwide in recent years. Studies shown that hyperlipidemia patients, especially those with a high level of serum low-density lipoprotein cholesterol (LDL-C), have a significantly higher prevalence of atherosclerosis, leading to coronary heart disease. Previous basic experiments and clinical studies have shown that Qushi Huayu granule (QSHY) can reduce blood lipids in patients with non-alcoholic fatty liver disease (NAFLD) accompanied by hyperlipidemia, but lack of clinical efficacy evaluation for patients with hyperlipidemia. This study aims to investigate the efficacy and safety of Qushi Huayu granule for Hyperlipidemia. Methods: This is a randomized, double-blind, placebo-controlled trial. 210 hyperlipidemia participants will be enrolled and randomized into QSHY or placebo granule groups in equal proportions, and receive treatment for 24 weeks. The primary outcome is the percentage change of LDL-C from baseline to week 12. Secondary outcomes are other serum lipid biochemical markers levels, life quality measuring health surveys, and Traditional Chinese Medicine (TCM) Pattern Scale. All related tests will be measured at baseline, week 12 and 24 after enrolment. Adverse events and safety of intervention will be monitored and evaluated.Discussion: We design a clinical trial of hyperlipidemia management with QSHY, a TCM formula. The results of this trial will present the efficacy and safety of QSHY in patients with hyperlipidemia, and provide clinical evidence for the treatment of hyperlipidemia.Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR2000034125. Registered on June 25, 2019.

scholarly journals Therapeutic Evaluation of Artesunate in IgA Nephropathy (TEATING) Study: A study protocol of a multicenter, double-blind, randomized, placebo-controlled trial

2021 ◽  
Author(s):  
Qi Chen ◽  
Zi Wang ◽  
Jicheng Lv ◽  
Lijun Liu ◽  
Hang Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Iga Nephropathy ◽  
Clinical Evidence ◽  
Kidney Diseases ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Patients At Risk ◽  
Stage Renal Disease

Abstract Background IgA nephropathy is the most common glomerular disease and a common cause of progression to end-stage renal disease in patients with kidney diseases. Proteinuria levels are critical to the prognosis of patients with IgA nephropathy, but many patients are still unable to effectively control proteinuria levels after receiving adequate RAAS blockers. Antimalarial drugs have shown good efficacy in the treatment of kidney disease in previous studies; however, there have been no strict designed randomized controlled trials to confirm the clinical efficacy of artesunate in IgA nephropathy patients. Therefore, we designed this clinical trial to compare the effect of artesunate versus placebo in patients with IgA nephropathy. Methods This study was a randomized, double-blind, three-group-parallel, placebo-controlled clinical trial. One hundred and twenty eligible IgA nephropathy patients at risk of progression were randomly divided into artesunate 100mg group, artesunate 50 mg group, and placebo group. Changes in proteinuria and renal function were measured after 6 months of intervention. The levels of Gd-IgA1, Anti-Gd-IgA1 in the patient's blood will also be tested to further understand possible immune mechanisms. Discussion Clinical evidence for artesunate treatment of IgA nephropathy is currently lacking, and we expect that the results of this trial will provide high-quality clinical evidence for artesunate as a treatment option for IgA nephropathy in the future. Trial registration: Chinese Clinical Trial Registry: ChiCTR2000038104, registration date: 10 September 2020. http://www.chictr.org.cn/edit.aspx?pid=61338&htm=4.

scholarly journals High dose vitamin C in sepsis (HDVCIS): study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Bing Zhao ◽  
Mengjiao Li ◽  
Jian Li ◽  
Leshan Liu ◽  
Yihui Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin C ◽  
Animal Studies ◽  
Controlled Trial ◽  
Small Scale ◽  
Controlled Clinical Trial ◽  
High Dose ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
High Dose Vitamin

Abstract Sepsis is an inflammatory syndrome with life-threatening organ dysfunction resulting from a dysregulated host response to infection. Although the treatment for sepsis has improved a lot in the last 30 years, sepsis related mortality remains high. In the recent 10 years, high dose intravenous injection of vitamin C, the first line antioxidant of human, has received more and more attention in the field of critical care, its beneficial effect has been demonstrated by several small scale clinical trial and animal studies, but the effect of high dose vitamin C on sepsis in a larger trial seems warranted in further study. Here we will conduct a prospective, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial named as HDVCIS. The trial protocol has been approved by Clinical Trail Ethics Committee of Ruijin Hospital of Shanghai JiaoTong University School of Medicine. This trial has been registered in Chinese Clinical Trial Registry (ChiCTR1800017633) in August 7, 2018. Patients will be recruited from 4 medical centers in China. Its object is to testify the efficacy and safety of high dose vitamin C in the treatment of sepsis.

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 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 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 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

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

BMJ Open ◽  
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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