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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Chao-ran Bi ◽  
Wei Jing ◽  
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. Last refreshed on December 4, 2019.

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 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 Safety of Ejiao (Asini Corii Colla) in Women With Blood Deficient Symptoms: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Li Zhang ◽  
Zhongju Xu ◽  
Tao Jiang ◽  
Jialu Zhang ◽  
Pinxian Huang ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Blood Cell ◽  
Control Group ◽  
Placebo Control ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Placebo Control Group ◽  
Sf 36

Equus asinus L [Equidae; Asini Corii Colla] (donkey-hide gelatin, Ejiao), a well-known traditional Chinese medicine, has been widely used to nourish the blood, especially for women. The aim of this study was to assess the efficacy and safety of Ejiao in blood-deficient patients. A total of 210 participants were recruited and randomly allocated into the placebo control group and Ejiao-treated group (6 g/day). The primary outcomes on the efficacy of Ejiao included traditional Chinese medicine symptom scores, blood indicators, and SF-36. The secondary outcomes were changes in fireness and safety evaluation. Results showed that Ejiao treatment for 8 weeks had significantly improved dizziness symptoms. Among the tested 24 blood biochemical parameters, the hematocrit and red blood cell numbers decreased in the placebo control group, but decreased significantly less in the Ejiao treatment group. The white blood cell and neutrophil counts increased in the Ejiao group but were within the normal range. In addition, the quality of life improved as the scores in SF-36 domains were significantly higher in the Ejiao group. At the same time, there was no significant change in the fire–heat symptoms score or other safety parameters. Considering all these, our study showed that Ejiao has a promising effect in women suffering from blood deficiency without obvious adverse effects.

scholarly journals Clinical Observation on the Effect of Chinese Medicine Five-Color Therapy on the Treatment of Children with Chronic Urticaria

2020 ◽  
Vol 4 (3) ◽  
Author(s):  
Yu Zhu ◽  
Lu Shi
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Chronic Urticaria ◽  
Statistical Significance ◽  
Effective Rate ◽  
Control Group ◽  
Color Treatment ◽  
Income Data ◽  
Grouping Method ◽  
Experimental Group

Objective: To analyze the clinical treatment effect of traditional Chinese medicine five-color therapy on chronic urticaria in children. Methods: The income data target of this article is 80 children with chronic urticaria. The grouping method is a randomized method with 40 children in each group. The experimental group was treated with five-color treatment of traditional Chinese medicine, and the control group was treated with western medicine. The incidence, treatment and recurrence of adverse reactions in children with chronic urticaria were compared between the two groups. Results: Showed total effective rate of children with chronic urticaria in the experimental group was compared with the control group, P<0.05, the data showed statistical significance. Conclusion: Stated use of TCM five-color therapy in the treatment of children with chronic urticaria can significantly improve safety.

scholarly journals Therapeutic Effect of Oral Administration and External Therapy of Traditional Chinese Medicine on Cervical Tuberculous

2019 ◽  
Vol 3 (3) ◽  
Author(s):  
Guoqiang Yang ◽  
Jin Zhang
Keyword(s):  
Statistical Analysis ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Oral Administration ◽  
Total Effective Rate ◽  
Statistical Significance ◽  
Effective Rate ◽  
Control Group ◽  
Treatment Data ◽  
Experimental Group

Objective: To analyze the clinical effect and value of oral administration and external therapy of traditional Chinese medicine for treatment of cervical tuberculous lymphadenopathy. Methods: A total of 56 patients with cervical tuberculous lymphadenopathy admitted to our hospital from January 1 to January 2018 were recruited. By using double-blind method, the patients were divided into control group (n=28) and experimental group (n=28). Control group comprised of patients with conventional anti-tuberculosis treatment, while the experimental group comprised of patients treated with oral administration and external therapy of traditional Chinese medicine. Total effective rate, incidence of complication and level of T lymphocyte subsets were compared between the two groups of cervical tuberculous lymphadenopathy patients. Results: Post-treatment data of total effective rate, complication rate, CD3+, CD4+, CD8+, CD4+/CD8+ of the experimental group were compared with the control group. P<0.05; statistical analysis showed statistical significance. Post-treatment data of CD3+, CD4+, CD8+, CD4+/CD8+ of both control and experimental groups were compared with pre-treatment data. P<0.05; statistical analysis showed statistical significance. Conclusion: Oral administration and external therapy of traditional Chinese medicine possesses significant effect in treatment of cervical tuberculous lymphadenopathy.

A Controlled Clinical Trial of Local Anesthesia for Lumbar Punctures in Newborns

PEDIATRICS ◽  
1991 ◽  
Vol 88 (4) ◽  
pp. 663-669 ◽  
Author(s):  
Fran L. Porter ◽  
J. Philip Miller ◽  
F. Sessions Cole ◽  
Richard E. Marshall
Keyword(s):  
Carbon Dioxide ◽  
Clinical Trial ◽  
Heart Rate ◽  
Lumbar Puncture ◽  
Local Anesthesia ◽  
Subcutaneous Administration ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Transcutaneous Oxygen ◽  
Experimental Group

To evaluate the efficacy of subcutaneous administration of lidocaine for reducing physiologic instability in acutely ill newborns during clinically required procedures, 81 neonates who required lumbar punctures within the first month of life were stratified by birth weight and respiratory support and randomly assigned to an experimental or a control group. The experimental group received an injection of 0.1 mL/kg of 1% lidocaine prior to the lumbar puncture. The control group received a nonanesthetized lumbar puncture without placebo. Changes in heart rate, respiratory rate, transcutaneous oxygen and carbon dioxide tensions, and heart rate variability from baseline, preparatory (positioning/handling), lumbar puncture, and recovery periods were measured. The administration of lidocaine did not minimize physiologic instability in response to the lumbar puncture nor was it associated with any detectable adverse effects other than prolonging the duration of the lumbar puncture. Although significant physiologic changes were observed in response to preparatory procedures, few additional changes beyond those occurred in response to lumbar punctures in either the experimental or control group. It is concluded that local anesthesia failed to influence manifestations of physiologic instability during neonatal lumbar punctures and that preparatory procedures were more destabilizing than either the administration of lidocaine or the lumbar puncture itself. The results suggest that the management of newborns requires emphasis on minimizing the destabilizing effects of required and frequent handling procedures.

EFFECT OF CHINESE MEDICINE ON MUSCLE FATIGUE OF ATHLETES

2021 ◽  
Vol 27 (7) ◽  
pp. 706-709
Author(s):  
Ma Jin
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Muscle Fatigue ◽  
T Test ◽  
The Body ◽  
Good Effect ◽  
Control Group ◽  
Exercise Fatigue ◽  
Experimental Group ◽  
Paired T Test

ABSTRACT Introduction: Traditional Chinese medicine has a very good effect on the treatment of exercise fatigue. However, if it is not handled actively and effectively, it can cause serious adverse effects on the body and lead to many diseases. Objective: To study the effect of TCM diagnosis and treatment on athletes’ exercise-induced muscle fatigue. Methods: The results of the study were analyzed by comparing the experimental data in the experimental group and the control group. Results: A paired t test was conducted on the experimental results of the experimental intervention group and the data of the control group. It was found that regardless of individuals being male or female, the paired t test results of the experimental group and the data of the control group were all P < 0.05, showing significant differences in the paired data. Conclusions: In the experiment, all the treatment methods of traditional Chinese medicine had an obvious effect in the treatment of exercise fatigue, and reduced the recovery time of exercise fatigue at different degrees. Contrastive analysis shows that traditional Chinese medicine is effective in the treatment of exercise fatigue. Level of evidence II; Therapeutic studies - investigation of treatment results.

scholarly journals Efficacy and Safety of Socheongryong-Tang Among Atopic Dermatitis Patients With Respiratory Disorders: A Double-Blinded, Randomized, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 11 ◽  
Author(s):  
Ju Hyun Lee ◽  
Eun Heui Jo ◽  
Jee Youn Jung ◽  
Young-Eun Kim ◽  
Mi-Ju Son ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Atopic Dermatitis ◽  
Safety Evaluation ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Inflammatory Skin Disease ◽  
Double Blinded ◽  
Study Participants ◽  
Experimental Group

Atopic dermatitis is a chronic inflammatory skin disease that affects the growth and development of children. The prevalence of atopic dermatitis has been continually increasing, and this has also been accompanied by rising socioeconomic costs. Interest has been growing in alternative medicine as a means of alleviating the burden of atopic dermatitis. This was a single-center, double-blinded, randomized, placebo-controlled investigator-led clinical trial including 60 atopic dermatitis patients. The participants were classified into an experimental group (30 persons) and a control group (30 persons), who were administered, respectively, socheongryong-tang or a placebo for 4 weeks. After 4 weeks of treatment, the participants visited the trial center again and assess their efficacy and safety. The researchers performed statistical comparisons of the changes in the SCORAD Index, amount and frequency of ointment use, and height and weight to assess the efficacy. To assess the safety, diagnostic tests and vital sign checks were performed at each visit, and the presence or absence of adverse events was observed. As a result, the frequency and the amount of steroid ointment application in both groups increased, but the experimental group showed less tendency (p = 0.081). Results of analyzing the children in the experimental group in relation to growth showed a significantly greater height growth than the control group (p &lt; 0.05). In addition, all study participants did not show any remarkable abnormal signs in the safety evaluation. In conclusion, compared to the control group, the experimental group, who took socheongryong-tang showed a tendency to be less dependent on steroid ointment and statistically significant increase in height.

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