Effectiveness and Safety of Niclosamaide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management: Randomized controlled clinical trial

Background: COVID-19 pandemic has ignited the urge for repurposing old drugs as candidate antiviral medicines to treat novel challenges of viral infections. Niclosamide (NCS) is an anti-parasitic drug of known antiviral potential. Therefore, this study attempts to investigate the antiviral effect and safety of NCS on SARS-CoV-2 caused COVID-19 patients. Methods: Randomized controlled open label clinical trial encompassed 75 COVID-19 patients treated with standard of care plus NCS were included as experimental group and 75 COVID-19 patients treated with only standard of care therapy as control group. Each group was composed of 25 mild, 25 moderate and 25 severe patients. Survival rate, time to recovery, and side effects were the main endpoints for the assessment of the therapeutic effect and safety of NCS. Results: NCS did not enhance survival rate as three of severe COVID-19 patients in NCS and in control groups died (P>0.05). However, NCS, compared to control group, reduced the time to recovery in moderate and severe COVID-19 patients about 5 and 3 days, respectively but not in mild patients (P≤0.05). Most interestingly, NCS lowered time to recovery up to five days in patients with co-morbidities (P≤0.05) whereas only one day lowered in patients without co-morbidities (P>0.05). Conclusion: It is concluded that NCS accelerates time to recovery about 3 to 5 days in moderate to severe COVID-19 patients especially those with co-morbidities; hence, NCS is of clinical benefit for freeing hospital beds for more patients in pandemic crisis.

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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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An open-label, randomized, controlled clinical trial to explore the curative effects between the treatment of capecitabine and andrographolide and the single capecitabine in the patients with pathological and/or histologic diagnosed unresectable, advanced, recurrent, and metastatic colorectal cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.4_suppl.tps819 ◽

2017 ◽

Vol 35 (4_suppl) ◽

pp. TPS819-TPS819 ◽

Cited By ~ 1

Author(s):

Yongqian Shu ◽

Jing Sun ◽

Peifen Cai ◽

Weicheng Wang ◽

Xiao Han ◽

...

Keyword(s):

Colorectal Cancer ◽

Clinical Trial ◽

Target Therapy ◽

The Elderly ◽

Control Group ◽

Controlled Clinical Trial ◽

High Dose ◽

Randomized Controlled Clinical Trial ◽

Open Label ◽

Randomized Controlled

TPS819 Background: Colorectal cancer (CRC) is one of the most commonly diagnosed solid tumors worldwide. Current therapies for the treatment of CRC mainly comprise fluoropyromidine-based chemotherapies that are used individually or in combination with oxaliplatin or/with target therapy. Andrographolide, a natural diterpenoid from Andrographispaniculata, has been reported to exert antibacterial, antiviral, anti-inflammation and neuroprotectiveactivities. Our previous studies have proved that Andrographolide can inhibit tumor growth in mice at a relatively high dose(about 200 mg/kg).The aim of the study is to make a comparison of PFS, RR, and OS of the elderly CRC between the treatment of xeloda and andrographolide and the signal xeloda.We look forward to these findings highlight the potential possibility of using this natural, safe and relatively inexpensivecompound as potential adjunctive treatments in improving the overall treatment response of patients with CRC in future. Methods: This is an open-label, randomized, controlled clinical trial. Patients older than or equal to 65, by pathological and/or histologic diagnosed unresectable, advanced, recurrent andmetastatic CRC, will be enrolled. These patients’ tumors must be clearly measured by radiographic technology. All cases of chemotherapy patients randomly divided into two groups, experimental group (xeloda with andrographolide): xeloda: 1250mg/m2 , po bid, d1–14, q3w; andrographolide: 500mg, ivd qd, d1–14, q3w; control group (xeloda): 1250mg/m2, po bid, d1–14, q3w, 21d/cycle. After each 2 cycles, patients will be examined by imageological tests (CT and/or MRI) or tumour biomarkers (CEA and CA199) to estimate the curative effects. Until the tumor progression or after 6 cycles, patients will be removed from this study. PFS is set as the primary endpoint while secondary endpoints include overall survival (OS), overall response rate (ORR), and health-related quality of life (HRQoL). Recruitment has begun in Jan 2014 and about 52 patients has joined this study. Clinical trial information: NCT01993472.

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Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial

Journal of Antimicrobial Chemotherapy ◽

10.1093/jac/dkaa334 ◽

2020 ◽

Vol 75 (11) ◽

pp. 3379-3385 ◽

Cited By ~ 12

Author(s):

Anahita Sadeghi ◽

Ali Ali Asgari ◽

Alireza Norouzi ◽

Zahedin Kheiri ◽

Amir Anushirvani ◽

...

Keyword(s):

Standard Care ◽

Controlled Trial ◽

Standard Of Care ◽

Control Group ◽

Controlled Clinical Trial ◽

University Hospitals ◽

Open Label ◽

Serious Adverse Events ◽

Clinical Recovery ◽

Randomized Controlled

Abstract Background Currently no effective antiviral therapy has been found to treat COVID-19. The aim of this trial was to assess if the addition of sofosbuvir and daclatasvir improved clinical outcomes in patients with moderate or severe COVID-19. Methods This was an open-label, multicentre, randomized controlled clinical trial in adults with moderate or severe COVID-19 admitted to four university hospitals in Iran. Patients were randomized into a treatment arm receiving sofosbuvir and daclatasvir plus standard care, or a control arm receiving standard care alone. The primary endpoint was clinical recovery within 14 days of treatment. The study is registered with IRCT.ir under registration number IRCT20200128046294N2. Results Between 26 March and 26 April 2020, 66 patients were recruited and allocated to either the treatment arm (n = 33) or the control arm (n = 33). Clinical recovery within 14 days was achieved by 29/33 (88%) in the treatment arm and 22/33 (67%) in the control arm (P = 0.076). The treatment arm had a significantly shorter median duration of hospitalization [6 days (IQR 4–8)] than the control group [8 days (IQR 5–13)]; P = 0.029. Cumulative incidence of hospital discharge was significantly higher in the treatment arm versus the control (Gray’s P = 0.041). Three patients died in the treatment arm and five in the control arm. No serious adverse events were reported. Conclusions The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone. Although fewer deaths were observed in the treatment arm, this was not statistically significant. Conducting larger scale trials seems prudent.

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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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Effect of Yoga on the Quality of Life of Nurses Working in Intensive Care Units. Randomized Controlled Clinical Trial

Investigación y Educación en Enfermería ◽

10.17533/udea.iee.v37n3e06 ◽

2019 ◽

Vol 37 (3) ◽

Author(s):

Khatereh Rostami ◽

Fariba Ghodsbin

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Intensive Care ◽

Intensive Care Units ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

Experimental Group

Objective. The work, herein, sought to determine the effect of yoga on the quality of life of nurses working in intensive care units (ICU). Methods. This was a randomized controlled clinical trial of a preventive intervention of three weekly sessions of yoga exercises, which included aspects of meditation, breathing control, and slow body movements. The study selected 70 nurses working in ICU and assigned them to two groups: experimental (n = 35) and control (n = 35). The World Health Organization Quality of Life brief questionnaire (WHOQoL-Bref) was used to evaluate on four moments (baseline, one, two, six months after the start of the study); this scale has 26 items with Likert-type response options ranging from 1 to 5; higher total score indicates better quality of life. Results. The baseline score of quality of life in the experimental group was 62.3, which increased to 70.7 on the first month and continued improving in the evaluations on the second month (72.8) and sixth month (74.1), with this change being statistically significant. Instead, the control group showed no differences in scores of the different moments of evaluation (baseline = 62, first month = 61.9, second month = 62.4, and sixth month = 60.4). In the four domains of the WHOQoL-Bref (physical, psychological, social relationships, and environment), it was also noted that the experimental group obtained better scores over time compared with the control group. Conclusion. The intervention of yoga exercises was effective in improving the quality of life of nurses working in ICU.Descriptors: yoga; exercise; meditation; nurses; quality of life; intensive care units; randomized controlled trial; surveys and questionnaires; encuestas y cuestionarios.How to cite this article: Rostami K, Ghodsbin F. Effect of Yoga on the Quality of Life of Nurses Working in Intensive Care Units. Randomized Controlled Clinical Trial. Invest. Educ. Enferm. 2019; 37(3):e06.

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A non-inferiority randomized controlled clinical trial comparing Unani formulations & PUVAsol in non-segmental vitiligo

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2021-0057 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Nazim Husain ◽

Qamar Uddin ◽

Munawwar Husain Kazmi ◽

Mohd Khalid

Keyword(s):

Clinical Trial ◽

Global Assessment ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Control Group ◽

Controlled Clinical Trial ◽

Open Label ◽

Randomized Controlled ◽

Safety Parameters ◽

Scoring Index

Abstract Objectives Greco-Arab medicine is an ancient system of medicine with greater treasure on therapeutics of vitiligo. The trial Unani formulations have not been scientifically explored for their safety and efficacy, but have been repeatedly prescribed by the great Unani physicians in the management of Baraṣ (vitiligo). Hence, these interventions were selected for the trial. Methods In this randomized, controlled, open-label clinical trial, 82 participants with non-segmental vitiligo aged 18–40 years were block randomized to either receive Unani interventions or control for 16 weeks. Out of 82 participants, 42 were randomized to the Unani group and 40 were randomized to the control group. The primary outcome measure was change in vitiligo area scoring index (VASI), which was assessed on weeks 4, 8, 12 and 16. The secondary outcome measures included the patient’s global assessment on VAS and investigator’s global assessment based on photographic evaluation at baseline and after the treatment. Safety parameters included hemogram, LFTs, RFTs, CXR, ECG, urine, and stool examinations, which were evaluated at baseline and after the treatment. Results The per-protocol analysis was done on 30 participants in each group and the response in Unani group was not inferior to those receiving control group. The mean ± SD of vitiligo area scoring index (VASI) decreased from 4.09 ± 2.87 and 5.50 ± 5.73 at baseline to 3.13 ± 2.20 and 4.29 ± 4.95 at the end of the trial in both the Unani and control groups respectively. Conclusions The study inferred that both the interventions are equally effective and well-tolerated in patients with non-segmental vitiligo.

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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/v1 ◽

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.

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Benefits of Dog-Assisted Therapy in Patients with Dementia Residing in Aged Care Centers in Spain

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18041471 ◽

2021 ◽

Vol 18 (4) ◽

pp. 1471

Author(s):

Eva Vegue Parra ◽

Jose Manuel Hernández Garre ◽

Paloma Echevarría Pérez

Keyword(s):

Scientific Evidence ◽

Alternative Therapy ◽

Group Versus ◽

Aged Care ◽

Control Group ◽

Controlled Clinical Trial ◽

Neuropsychiatric Inventory ◽

Randomized Controlled ◽

Institutionalized Patients ◽

Experimental Group

(1) Background: Currently, the scientific evidence on the benefits of assisted therapy with dogs in dementia is not clear. In this study, we want to evaluate such benefits through a randomized controlled clinical trial in multiple centers across the country. (2) Methods: The participants were people over 65 years old with dementia, residing in senior centers in Spain (n = 334). The experimental group underwent assisted therapy with dogs based on the Comprehensive Cognitive Activation Program in Dementia, for 8 months, with weekly sessions of 45 min. Data were collected at the commencement, middle, and end of the program, to evaluate the aspects using the Mini-Examination Cognitive, the modified Bartell Index, the Cornell Scale for Depression in Dementia and the Neuropsychiatric Inventory. (3) Results: The results show significant improvements in the experimental group versus the control group in the affective (T1 = p 0.000; T2 = p 0.000) and behavioral (T1 = p 0.005; T2 = p 0.000) aspects, with the affective aspect displaying greater progress in participants with additional depressive (p = 0.022) or anxiety (p = 0.000) disorders, shorter institutionalization periods (r = −0.222, p = 0.004), and those undergoing complementary psychotherapy (p = 0.033) or alternative therapy (p = 0.011). (4) Conclusions: Dog therapy is effective in improving the affective and behavioral aspects of institutionalized patients with dementia.

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