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 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 A Double Blind Clinical Trial on the Efficacy of Honey Drop in Vernal Keratoconjunctivitis

2014 ◽  
Vol 2014 ◽  
pp. 1-4 ◽  
Author(s):  
Ali Salehi ◽  
Solmaz Jabarzare ◽  
Mohammadreza Neurmohamadi ◽  
Soleiman Kheiri ◽  
Mahmoud Rafieian-Kopaei
Keyword(s):  
Clinical Trial ◽  
Vernal Keratoconjunctivitis ◽  
Control Group ◽  
Placebo Control ◽  
Eye Drops ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Placebo Control Group ◽  
Double Blind Clinical Trial

Purpose. This trial was designed to evaluate the efficacy and safety of topical honey eye drops in patients with diagnosed VKC.Methods. This clinical trial was conducted on 60 patients with diagnosed VKC. The patients were selected and randomly allocated between two groups of 30. Patients in two groups received honey eye drop (60% in artificial tear) or placebo, other than cromolyn and fluorometholone 1% eye drops, to be used topically in each eye, four times per day. The patients were examined with slit lamp and torch at baseline and the follow-up visits on the 1st, 3rd, and 6th months of the study for redness, limbal papillae, and intraocular pressure.Results. Out of 60 patients who completed the study, 19 patients (31.7%) were female. There was significant increase in eye pressure and reduction in redness as well as limbal papillae, following the consumption of the honey drop in honey group compared to placebo control group(P<0.05). At the end of trial, one patient in honey group and 7 ones in placebo group had limbal papillae(P<0.05).Conclusion. Topical honey eye drops, when used along with Cromolyn and Fluorometholone eye drops, might be beneficial for the treatment of VKC.

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.

Sulfinpyrazone And Prevention Of Postoperative Deep Venous Thrombosis(DVT)

1981 ◽  
Author(s):  
G Arapakis ◽  
A Trovas ◽  
G Orphanoudakis ◽  
P Vassilikos
Keyword(s):  
Arterial Thrombosis ◽  
Statistical Significance ◽  
Group Analysis ◽  
Control Group ◽  
Placebo Control ◽  
Double Blind Trial ◽  
Double Blind ◽  
Placebo Control Group ◽  
Postoperative Deep Venous Thrombosis ◽  
Surgical Operations

Though the antithrombotic properties of sulfinpyrazone (SP) in arterial thrombosis have been documented, its value in phlebothrombosis remains uncertain. In this randomized double-blind trial, the effect of SP (500mg I.M. twice daily for the first 10 postoperative days) on postoperative DVT was compared with a placebo control group. 96 (65 male and 31 female) patients 41 to 83 years of age undergoing major surgical operations were included in the trial. The composition of the two groups (treated and placebo) were homogenious regarding age, sex and type of operation (0,30<p<0,50). The incidence of DVT was estimated clinically and isotopically by the 125I-labelled figrinogen test.No clinical phlebothrombosis was observed in either group but DVT was detected isotopically in 4 (8,3%) out of 48 in the placebo and in 7 (14,5%) of the 48 in the SP group. Analysis by the x2 showed no statistical significance in the prevalence of postoperative DVT between the two groups (x2<x20,30/1). These results suggest that SP has no place in the prevention of postoperative DVT.

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 Efficacy and Safety of Modified Qing-Ying Decoction for Atopic Dermatitis in Children: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Mei Kwan LAI ◽  
Chi Him SUM ◽  
Connie YC KAM ◽  
Tianhe SONG ◽  
Pui Kuan CHEONG ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Atopic Eczema ◽  
Gut Microbiome ◽  
Secondary Outcome ◽  
Control Group ◽  
Placebo Control ◽  
Efficacy And Safety ◽  
Long Term Treatment

Abstract BackgroundAtopic Dermatitis (AD), also known as atopic eczema, is a chronic skin disease characterized by recurring episodes of itchiness with skin erythema and surface damages, such as dry skin, skin thickening and swelling. Long-term treatment with conventional medicine for subacute and moderate atopic eczema is not satisfactory. Evidence from randomized clinical trials suggests the effectiveness of Chinese medicine for the treatmement of AD. The purpose of this study is to explore the efficacy and safety of the modified Qing-Ying Decoction (mQYD) for the treatment of subacute and chronic AD in children through examining the clinical symptoms, quality of life, gut microbiome, and Chinese medicine (CM) body constitution.Methods/designThis is a parallel, randomized, placebo-controlled, double-blind clinical trial with a 12-week treatment and a 4-week follow-up period. A total of 64 participants will be randomly allocated to the treatment group receiving oral mQYD granules or the placebo control group receiving oral placebo granules. Eczema Area and Severity Index (EASI) score will be the primary outcome. Secondary outcome measures include change in symptoms using the Patient-Oriented Eczema Measure (POEM), the Children’s Dermatology Life Quality Index (CDLQI), and the use of concomitant medicines as well as the change in the gut microbiome and CM body constitution types after the 12-week treatment of the mQYD and 4-week follow-up compared to placebo control. Safety parameters include report of adverse events and pathology tests during the trial period.DiscussionThis is the first clinical trial of its kind to test the efficacy and gut microbiome of an innovative Chinese herbal formula modified from a famous ancient formula for the treatment of AD. The outcomes of this trial will provide clinical evidence on the effectiveness and safety of mQYD for the treatment of AD.Trial registrationClinicalTrials.gov, ID: NCT04419584. Registered on 28 July 2020.

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