scholarly journals Traditional Chinese Medicine (Xiao Tan San Jie Granule) for Covid-19 Patients in Rehabilitation Stage: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Yingshuai Li ◽  
Junwen Han ◽  
ying Zhang ◽  
Ji Wang ◽  
Jiangming He ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Outcome Assessment ◽  
Virus Disease ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry ◽  
Tcm Theory

Abstract Background: The Corona Virus Disease 2019 (Covid-19) caused pandemic all over the world. As more and more patients gradually are recovering from Covid-19, they still have some symptoms like short of breath, cough, and phlegm. how to improve their quality of life and shorten the rehabilitation time is still no widely recognized clinical program. In this study, we designed Xiao Tan San Jie (XTSJ) Granule based on traditional Chinese medicine (TCM) theory and assess its efficiency and safety during rehabilitation stage of Covid-19 patients. Method/Design: This study is a 12-week, randomized, double-blinded, controlled, clinical trial that will include 132 Covid-19 patients. Eligible participants will be randomly assigned to XTSJ granule group or placebo group. Participants will receive 28 days treatment. The primary outcome assessment is scores of lung CT scan at week 2 and week 4. The secondary outcome assessment includes pulmonary function test, scores of Visual Analogue Scale (VAS) of Covid-19 symptoms, Scores of Qi Deficiency and Phlegm Stasis syndrome scale, Scores of St. George's Respiratory Questionnaire (SGRQ) at week 2 and week 4. Discussion: In TCM theory XTSJ granule has a regulate effect on respiratory function, lung infection, cough and phlegm which has the potential treatment effect on COVID19 patients. This study will provide initial evidence regarding the efficacy and safety of XTSJ granule for Covid-19 patients in rehabilitation stage. Trial registration: This study was prospectively registered on Chinese Clinical Trial Registry( number: ChiCTR2000031672). Registration date: April 6,2020.

scholarly journals The effect of Xuanbai Chengqi decoction on patients with pneumonia-derived sepsis: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Zhang Jun ◽  
Yi Yu ◽  
Bojun Zheng ◽  
Huang Jing
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
Antibiotic Use ◽  
Lavage Fluid ◽  
Plateau Pressure ◽  
Lung Compliance ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry

Abstract Background: Sepsis and septic shock are major healthcare problems. pneumonia-derived is one of the important aspects of sepsis. The theory of traditional Chinese medicine (TCM) dictates that diseases of the lung and those of the large intestine react with each other. Methods/Design: A single-blind, randomised controlled clinical trial will be conducted involving 90 patients with pneumonia-derived sepsis. Participants will be randomised at a 1:1 ratio to receive Xuanbai Chengqi decoction (XCD) (experimental arm) or the same amount of saline treatment (control arm). The intervention will comprise one session/day for 1 week. The primary outcomes will be 28-day mortality, and levels of pro-inflammatory cytokines in bronchoalveolar lavage fluid and serum and static lung compliance, dynamic lung compliance, plateau pressure, and peak airway pressure, 1, 3 and 7 days after treatment completion with respect to baseline levels. Secondary outcomes will be the symptom score of traditional Chinese medicine, duration of parenteral nutrition, prevalence of complications and the course of antibiotic use. Measurements will be taken at baseline, 1, 3 and 7 days during the intervention, after 28 days after completing the intervention. Adverse events between arms will be evaluated. Discussion: This is the first trial to evaluate the effects of XCD on management of pneumonia-derived sepsis. If the results are as expected, they will provide evidence of XCD in promoting the results in pneumonia-derived sepsis patients. Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900024072. Registered on 24 June 2019.

scholarly journals Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Secondary Outcome ◽  
Specific Information ◽  
Clinical Trial Registry ◽  
Data Set ◽  
Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

scholarly journals Efficacy and safety of Xiaoyao pills for mild to moderate depression: study protocol for a randomized controlled trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Zhe Xue ◽  
Zhen Huang ◽  
Shu-li Cheng ◽  
Xi-hong Wang ◽  
Xuan Zhou ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Adverse Reactions ◽  
Controlled Trial ◽  
Depression Scale ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Hamilton Depression Scale ◽  
Efficacy And Safety ◽  
Moderate Depression

Abstract Background Depression is one of the most frequent and severe psychiatric conditions. Many chemical drugs to treat depression are associated with adverse reactions and have shortcomings. Traditional Chinese medicine is of great significance in the prevention and treatment of depression. Xiaoyao pills has achieved good results in clinical application, which has the advantages of quick effect and no obvious adverse reactions. The aim of our study is to evaluate the efficacy and safety of Xiaoyao pills on mild to moderate depression patients. Methods This study is a multi-centre, double-blinded, randomized and placebo-controlled clinical trial. A total of 108 participants are assigned to three groups: Xiaoyao pill group taking Xiaoyao pills twice daily for 4 weeks, placebo group taking placebos twice daily for 4 weeks and normal group without taking any drug. The primary and secondary outcome measures are the Hamilton Depression Scale (HAMD) and Traditional Chinese Medicine (TCM) Syndrome Scale. The assessment is at baseline (before treatment initiation), 1 week, 2 weeks 4 weeks after the first treatment. Exploratory outcome is also assessed to explore the mechanism of Xiaoyao pills at baseline and 4 weeks. Discussion The results from this study will provide clinical evidence on the efficacy and safety of Xiaoyao pills in patients with mild to moderate depression with syndrome of liver stagnation and spleen deficiency. Trial registration ClinicalTrials.gov ISRCTN12746343. Registered on September 25, 2020.

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 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 Efficacy and mechanism of traditional Chinese medicine in relieving antibiotic-resistant bacterial diarrhea in children：study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Chao-ran Bi ◽  
Jing Wei ◽  
Xiao-fei Xie ◽  
Yan-jing Liu
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Pathogenic Bacteria ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Antibiotic Resistant ◽  
Experimental Group ◽  
Basic Treatment ◽  
Bacterial Diarrhea

Abstract Background: Bacterial infection is an important cause of diarrhea in children, potentially leading to malnutrition, growth and development disorders, and even death. Antibiotic abuse and resistance are widespread problems worldwide, especially in China. We therefore designed a study to evaluate the clinical efficacy and mechanism of traditional Chinese medicine in alleviating the effects of antibiotic resistance in childhood bacterial diarrhea and enhancing the sensitivity of pathogenic bacteria to antibiotics.Methods: This randomized, double-blind, placebo-controlled clinical trial has completed ChiCTR registration. The trial will randomly divide 120 children who meet the inclusion criteria into three groups: experimental group 1 (basic treatment + Gegen Qinlian decoction granules + Erbai drink placebo); experimental group 2 (basic treatment + Erbai drink granules + Gegen Qinlian decoction placebo); and control group (basic treatment + Gegen Qinlian decoction placebo + Erbai drink placebo). The main efficacy indicators will be antibiotic use rate and clinical cure rate, and the secondary efficacy indicators will be time to antibiotic intervention, effective rate, and course of treatment determined after 5 days. The following physical and chemical indicators will be measured: routine blood parameters, procalcitonin, C-reactive protein, electrocardiogram, liver and kidney function, electrolytes, routine urinalysis, routine stool analysis, and stool culture (including drug sensitivity). Discussion: The results of this study may provide an objective clinical basis for the use of traditional Chinese medicine in managing antibiotic-resistant bacterial diarrhea in children, formulating relevant guidelines, and demonstrating the use of traditional Chinese medicine for reducing the use of antibiotics.Trial registration: Chinese Clinical Trial Registry, ChiCTR1900027915. Date of last refreshed on 12/4/2019, http://www.chictr.org.cn/index.aspx.

scholarly journals Safety and immunogenicity of inactivated SARS-CoV-2 vaccine in high-risk occupational population: a randomized, parallel, controlled clinical trial

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Yongliang Feng ◽  
Jing Chen ◽  
Tian Yao ◽  
Yue Chang ◽  
Xiaoqing Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Neutralizing Antibodies ◽  
Health Care Systems ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Neutralizing Antibody ◽  
Shanxi Province ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) have a substantial burden on health-care systems around the world. This is a randomized parallel controlled trial for assessment of the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, aiming to determine an appropriate vaccination interval of the vaccine for high-risk occupational population. Methods In an ongoing randomized, parallel, controlled phase IV trial between January and May 2021 in Taiyuan City, Shanxi Province, China, we randomly assigned the airport ground staff and public security officers aged 18 to 59 years to receive two doses of inactivated SARS-CoV-2 vaccine at 14 days, 21 days, or 28 days. The serum neutralizing antibody to live SARS-CoV-2 was performed at baseline and 28 days after immunization. Long-term data are being collected. The primary immunogenicity endpoints were neutralization antibody seroconversion and geometric mean titer (GMT) at 28 days after the second dose. Analysis of variance (ANOVA), chi-square, and logistic regression analysis were used for data analysis. Results A total of 809 participants underwent randomization and received two doses of injections: 270, 270, 269 in the 0–14, 0–21, and 0–28 vaccination group, respectively. By day 28 after the second injection, SARS-CoV-2 neutralizing antibody of GMT was 98.4 (95% CI: 88.4–108.4) in the 0–14 group, which was significantly lower compared with 134.4 (95% CI: 123.1–145.7) in the 0–21 group (P < 0.001 vs 0–14 group) and 145.5 (95% CI: 131.3–159.6) in the 0–28 group (P < 0.001 vs 0–14 group), resulting in the seroconversion rates to neutralizing antibodies (GMT ≥ 16) of 100.0% for all three groups, respectively. The intention-to-treat (ITT) analysis yielded similar results. All reported adverse reactions were mild. Conclusions Both a two-dose of inactivated SARS-CoV-2 vaccine at 0–21 days and 0–28 days regimens significantly improved SARS-CoV-2 neutralizing antibody level compared to the 0–14 days regimen in high-risk occupational population, with seroconversion rates of 100.0%. Trial registration Chinese Clinical Trial Registry, ChiCTR2100041705, ChiCTR2100041706. Registered 1 January 2021, www.chictr.org.cn. Graphical Abstract

scholarly journals Effects of Acupuncture on the Hypothalamus-Pituitary-Adrenal Axis in Chronic Insomnia Patients: A Study Protocol for a Randomized Controlled Trial

2019 ◽  
Author(s):  
Chengyong Liu ◽  
Shiyu Zheng ◽  
Wenzhong Wu ◽  
Xiaoqiu Wang ◽  
Shan Qin ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Severity Index ◽  
Chronic Insomnia ◽  
Secondary Outcome ◽  
Therapeutic Effects ◽  
Before And After ◽  
Fatigue Severity

Abstract Background : Acupuncture, as an important component of traditional Chinese medicine (TCM), has been widely applied in the treatment of chronic insomnia in China，while there is no clinical study related to its therapeutic mechanism. Methods/design : A single-center, single-blind, randomized, placebo-controlled trial will be conducted at Jiangsu Hospital of Traditional Chinese Medicine. A total of 60 patients will be registered.Eligible participantswill be randomly divided into acupuncture group and shamacupuncture group (n = 30 cases in each group). Patients in both groups will be treated once every other day, 3 times per week for 4 weeks.The primary outcome measures are Pittsburgh Sleep Quality Index (PSQI), concentrations of adrenocorticotropic hormone (ATCH), Corticotrophin-releasing hormone (CRH), and cortisol (CORT). Secondary outcome measures are Insomnia Severity Index (ISI) and Fatigue Severity Scale (FSS). Discussion : This study aims to evaluate the therapeutic effects of acupuncture on chronic insomnia by using PSQI, ISI, and FSS. The mechanism of acupuncture on CIPs will be preliminarily discussed by analyzing the changes in concentrations of CRH, ACTH, and CORT before and after treatment.

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