scholarly journals Chinese medicine (Q-14) in the Treatment of Patients with Coronavirus Disease 2019 (COVID-19): A Single-center, Open label, Randomised Controlled Trial

2021 ◽  
Author(s):  
Jia Liu ◽  
Wei Yang ◽  
Yue Liu ◽  
Cheng Lv ◽  
Lianguo Ruan ◽  
...  
Keyword(s):  
Treatment Group ◽  
Standard Care ◽  
Controlled Trial ◽  
Control Group ◽  
Chest Discomfort ◽  
Open Label ◽  
Conversion Time ◽  
Q 14 ◽  
Randomised Controlled ◽  
And Control

ABSTRACTOBJECTIVETo evaluate the efficacy and safety of Chinese medicine (Q-14) plus standard care compared with standard care alone in adult with coronavirus disease 2019 (COVID-19).Study DESIGNSingle-center, open label, randomised controlled trial.SETTINGWuhan Jinyintan Hospital, Wuhan, China, February 27 to March 27, 2020.PARTICIPANTS204 patients with laboratory confirmed COVID-19 were randomised in to treatment group and control group, which was 102 patients each group.INTERVENTIONSIn treatment group, Q-14 was administrated at 10g (granules), twice daily for 14 days and plus standard care. In control group, patients were given standard care alone for 14 days.MAIN OUTCOME MEASUREThe primary outcome was conversion time of SARS-CoV-2 viral assay. Adverse events were analyzed in the safety population.RESULTSAmong 204 patients, 195 were analyzed according to the intention to treat principle. There were 149 patients (71 vs. 78 in treatment group and control group respectively) turning to negative via SARS-CoV-2 viral assay. No statistically significance showed in conversion time between treatment group and control group (FAS: Median (IQR): 10.00 (9.00-11.00) vs. 10.00 (9.00-11.00); Mean rank: 67.92 vs. 81.44; P=0.051.). Time to recovery of fever was shorter in treatment group as compared in control group. The disappearance rate of symptom in cough, fatigue, chest discomfort was significantly higher in treatment group. In chest computed tomography (Chest CT) examinations, overall evaluation of chest CT examination after treatment compared with baseline showed more patients improved in treatment group .There were no significant differences in the other outcomes.CONCLUSIONAdministration of Q-14 on standard care for COVID-19 was useful for improvement of symptoms (such as fever, cough, fatigue and chest discomfort), while did not result in a significantly higher probability of negative conversion of SARS-CoV-2 viral assay. No serious adverse events were reported.TRIAL REGISTRATIONChiCTR2000030288

scholarly journals Safety and Efficacy of Repurposed Siddha Medicines in Mild, Moderate, and Severe COVID-19 Patients Admitted To a Government Tertiary Hospital Near Chennai, Tamil Nadu– An Open-Labeled, Randomized, Controlled Trial.

2021 ◽  
Author(s):  
Christian G J ◽  
Meenakumari Ramasamy ◽  
Shanthimalar Ramalingam ◽  
Sankar Ganesan ◽  
Ravichandran Vadugam Muthusamy ◽  
...  
Keyword(s):  
Treatment Group ◽  
Standard Care ◽  
Tamil Nadu ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Tertiary Hospital ◽  
Control Group ◽  
Open Label ◽  
Randomized Controlled ◽  
Oxygenation Status

Abstract BackgroundCOVID-19 resulted in loss of human lives owing to respiratory failure caused by dysregulated immune system. Though many treatments are evaluated, the most appropriate is yet to be established. We hypothesized accelerated recovery and reduced mortality in mild, moderate and severe COVID-19 with Siddha regimen consisting of natural products.MethodsIn a randomized, controlled open-label trial conducted on 200 hospitalized COVID-19 patients, they were allocated equally to be treated with add-on Siddha regimen with Standard care or only standard care. The primary and secondary end points were accelerated recovery (≤ 7 days) and mortality comparison between the groups respectively. Patients were followed through 90 days.ResultsIn this study the accelerated recovery was 59.0% and 27.0% in treatment and control group (ITT analyses) (p < 0.001) respectively and Odds for it were four times higher in the treatment group (OR: 3.9; 95% CI: 1.9, 8.0). The estimated median time for recovery in the treatment group was 7 days (95% CI: 6.0, 8.0; p=0.003) and 10 days (95% CI: 8.7, 11.3) in control. Hazard ratio for death in control was 2.3 times that of treatment group. No adverse reactions or alarming laboratory values were observed in response to intervention. In severe treatment group (n=80), mortality was 15.0% and 39.5% in control (n=81). The COVID stage progression was 65% less in treatment group.ConclusionSiddha regimen demonstrated that they can synergistically improve oxygenation status, enhance the recovery rate and reduce the mortality better as compared to only Standard of Care.

scholarly journals Efficacy and Safety of Lianhuaqingwen Capsules for the Prevention of Coronavirus Disease 2019: A Prospective Open-Label Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Xiaowei Gong ◽  
Boyun Yuan ◽  
Yadong Yuan ◽  
Fengju Li
Keyword(s):  
Nucleic Acid ◽  
Treatment Group ◽  
Close Contact ◽  
Controlled Trial ◽  
Control Group ◽  
Open Label ◽  
Medical Observation ◽  
Observation Period ◽  
Close Contacts ◽  
Nucleic Acid Tests

Coronavirus disease 2019 (COVID-19) has become a global pandemic. Community and close contact exposures continue to drive the COVID-19 pandemic. There is no confirmed effective treatment for suspected cases and close contacts. Lianhuaqingwen (LH) capsules, a repurposed Chinese herbal product that is currently on the market, have proven effective for influenza and COVID-19. To determine the safety and efficacy of LH capsules for the prevention of COVID-19, we conducted a prospective open-label controlled trial of LH capsules on subjects who had close contact with people infected with COVID-19. Subjects received LH capsules (4 capsules, three times daily) or the usual medical observation for 14 days. The primary endpoint was the rate of positive nucleic acid tests of nasal and pharyngeal swabs during the quarantine medical observation period. We included 1976 patients, including 1101 in the treatment group and 875 in the control group. The rate of positive nucleic acid tests in the treatment group was significantly lower than that in the control group (0.27% vs. 1.14%, respectively; mean difference: −0.87%; 95% CI: −1.83 to −0.13; p = 0.0174 ) during the quarantine medical observation period (14 days). Among subjects with different close contact states, there was no significant difference in the rate of positive nucleic acid test results among close contacts in the treatment group and the control group (6.45% vs. 11.43%, respectively; p = 0.6762 ). Among secondary close contacts, the rate of positive nucleic acid tests in the treatment group was significantly lower than that in the control group (0.09% vs. 0.71%, respectively; p = 0.0485 ). No serious adverse events were reported. Taken together, and in light of the safety and effectiveness profiles, these results show that LH capsules can be considered to prevent the progression of COVID-19 after close contact with an infected person. This trial is registered with ChiCTR2100043012.

The Nature stroke study; NASTRU - A randomised controlled trial of nature-based post-stroke fatigue rehabilitation

2019 ◽  
Author(s):  
Anna María Pálsdóttir ◽  
Kjerstin Stigmar ◽  
Bo Norrving ◽  
Patrik Grahn ◽  
Ingemar F Petersson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Perceived Value ◽  
Control Group ◽  
Post Stroke ◽  
Randomised Controlled

Abstract Fatigue is common after stroke and contributes to disability and impaired quality of life. Currently, there is insufficient evidence on the efficacy of any intervention for post-stroke fatigue. The aim of the study was to examine whether 10 weeks Nature-based rehabilitation (NRB) as add-on to standard care may improve post-stroke fatigue, perceived value of everyday occupations, function, activity and participation compared to standard care only (Clinical Trial.gov Identifier: NCT02435043, 2012/352, 05-06-2015). The study was carried out as a single blinded two-armed randomised controlled trial. Stroke survivors identified through routine 3-month follow-up visit (sub-acute) or medical records (chronic stroke > 1 year earlier) were randomised to Standard care + NBR or Standard care only. Blinded evaluations were conducted at follow-up 8 and 14 months after randomisation. The primary outcomes were post-stroke fatigue (Mental Fatigue Scale, total score) and perceived value of everyday occupations (Oval-pd) 8 months after randomisation. About a quarter of the screened patients were eligible; half accepted to participate and 101 were randomised, mean age 67 years, 60% female. The patients with sub-acute stroke were highly compliant with the intervention. Fatigue decreased to a value below the suggested cut-off for mental fatigue (<10.5) in the intervention group but not in the control group; no statistically significant differences were found though between the groups. Conclusion: NASTRU is the first randomised study on NBR for patients with post stroke fatigue. NBR was feasible and well tolerated. The study was underpowered due to difficulties in recruiting participants. No significant differences were detected between intervention and control group. A larger RCT is warranted. Keywords: clinical trial, enriched environment, everyday occupations, horticulture therapy, quality of life.

Immediate Effect of Scalp Acupuncture on the Gait of Patients with Subacute Intracerebral Haemorrhage Analysed by Three-Dimensional Motion: Secondary Analysis of a Randomised Controlled Trial

2018 ◽  
Vol 36 (2) ◽  
pp. 71-79 ◽  
Author(s):  
Hai-Qiao Wang ◽  
Gui-Rong Dong ◽  
Chun-Ling Bao ◽  
Zhi-Hua Jiao
Keyword(s):  
Treatment Group ◽  
Acupuncture Treatment ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Three Dimensional ◽  
Scalp Acupuncture ◽  
Control Group ◽  
Kinematic Parameters ◽  
Spatiotemporal Parameters ◽  
Randomised Controlled

Objective To investigate the immediate effect of scalp acupuncture on walking pattern, using three-dimensional gait analysis (3D-GA), among patients in the subacute stage of intracerebral haemorrhage (ICH). Methods A subset of 30 patients with subacute ICH participating in a recently published randomised controlled trial who were able to walk independently were assessed by 3D-GA before and immediately after scalp acupuncture treatment (treatment group) or no intervention (control group) and the results presented here as a secondary analysis. The acupuncture manipulation was repeated three times with an interval of 5 min. Spatiotemporal and kinematic parameters during walking were collected and analysed using a 3D motion analysis system. Results After treatment, there were significant differences between the treatment and control groups in the spatiotemporal parameters of step length, velocity and cadence (p<0.05) and double-limb support. No significant difference was found in step width. When kinematic parameters were evaluated, the treatment group showed a significantly decreased peak pelvic anterior tilt angle and an increased hip extension angle after scalp acupuncture treatment, whereas the control group demonstrated no temporal changes. There were no significant changes in any other kinematic parameters in either group. Conclusions As the first exploratory study to investigate the effect of the scalp acupuncture on gait performance in patients with subacute ICH, this secondary analysis of a recent randomised trial suggested an immediate effect of treatment on spatiotemporal parameters. Improvement in gait pattern may be associated with a decreased anterior tilt of the pelvis and augmented hip joint motion during walking. Trial Registration Number ChiCTR-TRC-08000225; Post-results.

scholarly journals Ganji Formulation for Patients with Hepatocellular Carcinoma Who Have Undergone Surgery: A Multicenter, Randomized, Double-Blind, Controlled Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-6
Author(s):  
Jing-Hao Zhang ◽  
Chao Zheng ◽  
Xiao-Jun Zhu ◽  
Xin Zhang ◽  
Zhi-Jun Hou ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Treatment Group ◽  
Liver Resection ◽  
Controlled Trial ◽  
Disease Free Survival ◽  
Control Group ◽  
Double Blind ◽  
Local Ablation ◽  
Significant Difference ◽  
And Control

Objective. To ascertain the efficacy and safety of Ganji Formulation (GF) for patients with Hepatocellular carcinoma (HCC) who had undergone surgery. Materials and Methods. A total of 262 HCC patients who had undergone liver resection, local ablation, or transcatheter arterial chemoembolization (TACE) were divided randomly into the treatment group and control group. The former was treated with GF and the later with placebo, both for 6 months. The primary endpoint was overall survival (OS). Second endpoints were disease-free survival (DFS) or time to disease progression (TTP). Results. OS of the treatment group was significantly longer than that of the control group (P < 0.05). Subgroup analysis showed that, for patients who received TACE, the TTP was significantly longer in the treatment group than in the control group (P < 0.05). However, for patients who underwent liver resection or local ablation, there was no significant difference in DFS between the two groups (P > 0.05). Conclusion. GF could improve postoperative cumulative survival and prolong the TTP. This clinical trial number is registered with ChiCTR-IOR-15007349.

scholarly journals Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024589
Author(s):  
Wen Yao Mak ◽  
Loke Meng Ong ◽  
Bak Leong Goh ◽  
Sunita Bavanandan ◽  
Lily Mushahar ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Open Label ◽  
Randomised Controlled ◽  
End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

P5307A consumer-direct digital health intervention for cardiovascular risk management in primary care: the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) randomised controlled trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Redfern ◽  
T Usherwood ◽  
G Coorey ◽  
J Mulley ◽  
A Scaria ◽  
...  
Keyword(s):  
Digital Health ◽  
Controlled Trial ◽  
Health Interventions ◽  
Control Group ◽  
Physically Active ◽  
Ehealth Literacy ◽  
Health Strategy ◽  
Randomised Controlled ◽  
And Control

Abstract Background Digital health interventions linked to electronic health records offer patients an innovative approach to support cardiovascular disease (CVD) risk management. Purpose Test the effectiveness of a consumer-directed digital health strategy on medication adherence and cardiovascular health outcomes in patients presenting to primary care who are at moderate to high risk of CVD. Methods Randomised controlled trial (RCT) with 12 month follow-up. Intervention group received an interactive digital health strategy for CVD management. The intervention was integrated with patient's electronic health record to enable automated population of risk factor and medication data (Figure). Control group received usual care. Primary outcome was the proportion of patients taking guideline-recommended BP and cholesterol-lowering medications on at least 80% of days (administrative data). Secondary outcomes included mean SBP, LDL-cholesterol, BMI and proportion meeting risk targets for physical activity, achieving smoking cessation, quality of life (EQ5D) and ehealth literacy (eHEALS). Results Intervention (n=486) and control (n=448) groups were well matched at baseline (Table). Mean age of participants was 67±8.1 years, 77% were male, 41% had existing CVD. At 12 months, there was no significant difference between the groups for medication days covered or mean cholesterol and BP (Table). However, there were significantly more patients in the intervention than control group who were physically active and had high ehealth literacy (Table). Table 1. Primary and Secondary Outcomes Baseline 12 months Outcome Control (n=448) Intervention (n=486) Control (n=431) Intervention (n=460) p value* Taking BP and cholesterol medication on ≥80% of days, % 29.7 28.9 29.9 32.8 0.485 SBP (mmHg), mean±SD 139.0±16.6 137.3±15.9 136.3±16.1 136.4±17.6 0.921 LDL (mmol/L), mean±SD 2.6±1.0 2.6±1.0 2.5±0.9 2.4±1.0 0.240 BMI (kg/m2), mean±SD 29.7±5.1 29.9±5.7 29.4±5.0 29.7±5.7 0.508 Proportion achieving BP and LDL target, % 11.2 12.3 11.7 16.5 0.065 Physically active, % 84.0 85.4 79.7 87.0 0.016 Current smoker, % 12.9 13.0 12.0 8.1 0.087 eHEALS, mean±SD 27.0±6.4 27.0±6.4 26.4±7.5 28.3±6.3 0.002 *Comparing intervention and control at 12 month follow-up. Conclusions The integrated digital health strategy did not significantly impact on days of medication covered however, patients in the intervention had higher physical activity and ehealth literacy. The RCT highlights the importance of conducting robust research if we are to understand the potential value of digital health interventions. Acknowledgement/Funding This work was supported by a Project Grant from the National Health and Medical Research Council of Australia

scholarly journals RelAte: pilot study of the effects of a mealtime intervention on social cognitive factors and energy intake among older adults living alone

2016 ◽  
Vol 116 (9) ◽  
pp. 1573-1581 ◽  
Author(s):  
Joanna E. McHugh Power ◽  
Olga Lee ◽  
Niamh Aspell ◽  
Emma McCormack ◽  
Michelle Loftus ◽  
...  
Keyword(s):  
Older Adults ◽  
Treatment Group ◽  
Energy Intake ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Complex Interventions ◽  
Living Alone ◽  
Control Group ◽  
Nutritional Interventions ◽  
Randomised Controlled

AbstractMealtime interventions typically focus on institutionalised older adults, but we wanted to investigate whether they may also be effective among those living independently. Using a randomised controlled trial design, we assessed the effects of a novel mealtime intervention on self-efficacy, food enjoyment and energy intake. A total of 100 adults living alone aged over 60 years were randomised to the treatment or control conditions: all received a guidebook on nutrition and culinary skills. Treatment group participants received a weekly visit from a trained volunteer who prepared and shared a meal with them. Participants in the treatment group showed improvements relative to those in the control group at borderline significance (P=0·054) for self-efficacy and at significance for food enjoyment. Significant improvements were observed in female participants in the treatment but not in the control group in energy intake (although following corrections for multiple comparisons, only the effect on food enjoyment remained significant). These findings will inform the design of future complex interventions. For this type of intervention to be successful, more focus has to be placed on making interventions more personalised, potentially according to sex. Findings are important for nutritional sciences as they indicate that, in order to improve energy intake and food enjoyment among older adults, multimodal nutritional interventions including social components may be successful.

London–East Anglia randomised controlled trial of cognitive–behavioural therapy for psychosis

1997 ◽  
Vol 171 (4) ◽  
pp. 319-327 ◽  
Author(s):  
Elizabeth Kuipers ◽  
Philippa Garety ◽  
David Fowler ◽  
Graham Dunn ◽  
Paul Bebbington ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Standard Care ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Psychotic Symptoms ◽  
Control Group ◽  
Improve Outcome ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundA series of small, mainly uncontrolled, studies have suggested that techniques adapted from cognitive–behavioural therapy (CBT) for depression can improve outcome in psychosis, but no large randomised controlled trial of intensive treatment for medication-resistant symptoms of psychosis has previously been published.MethodSixty participants who each had at least one positive and distressing symptom of psychosis that was medication-resistant were randomly allocated between a CBT and standard care condition (n=28) and a standard care only control condition (n=32). Therapy was individualised, and lasted for nine months. Multiple assessments of outcome were used.ResultsOver nine months, improvement was significant only in the treatment group, who showed a 25% reduction on the BPRS. No other clinical, symptomatic or functioning measure changed significantly. Participants had a low drop-out rate from therapy (11%), and expressed high levels of satisfaction with treatment (80%). Fifty per cent of the CBT group were treatment responders (one person became worse), compared with 31% of the control group (three people became worse and another committed suicide)ConclusionsCBT for psychosis can improve overall symptomatology. The findings provide evidence that even a refractory group of clients with a long history of psychosis can engage in talking about psychotic symptoms and their meaning, and this can improve outcome.

scholarly journals Ehretia Microphylla (Tsaang Gubat) versus Loratadine as Treatment for Allergic Rhinitis: A Randomized Controlled Trial

2018 ◽  
Vol 32 (2) ◽  
pp. 6-10 ◽  
Author(s):  
Fatima Angela C. Umali ◽  
Antonio H. Chua
Keyword(s):  
Allergic Rhinitis ◽  
Treatment Group ◽  
Nasal Congestion ◽  
Controlled Trial ◽  
Control Group ◽  
Post Intervention ◽  
Intermittent Allergic Rhinitis ◽  
Vas Scores ◽  
And Control ◽  
Snot 22

  Objective:  To determine if Ehretia microphylla (Tsaang Gubat) decoction tea and placebo can improve the symptoms of mild intermittent allergic rhinitis in comparison to loratadine and control tea.   Methods: Study Design:            Double blind, Randomized Controlled Trial Setting:                       Tertiary Government Training Hospital Subjects:                    Twenty-four patients diagnosed with mild intermittent allergic rhinitis from October 2015 to July 2016 were randomly divided into a treatment group given Ehretia microphylla (Tsaang Gubat) decoction tea and placebo, and a control group given control tea and loratadine, both taken for 7 days. Patients underwent pre–  and post–intervention evaluation by anterior rhinoscopy, Sino-nasal Outcome Test 22 (SNOT 22) Questionnaire and 10-point Visual Analog Scale (VAS). Data were encoded and subjected to statistical analysis using Mann Whitney U test, and Wilcoxon Signed Rank test.   Results: Age and gender of the treatment and control group participants were comparable. Prior to intervention, no differences in symptoms were noted between both groups on SNOT 22 and VAS scores. After intervention, no differences in symptoms were noted between the 2 groups on SNOT 22 and VAS scores either. Comparison of pre- (30.4 ± 17.3) and post- (7.2 ± 6.5) intervention mean SNOT 22 scores of the loratadine control group with pre- (32.5 ± 23.7) and post- (7.8 ± 10.4) intervention mean SNOT 22 scores of the Ehretia Microphylla treatment group showed significant improvement of symptoms in both groups. Likewise, comparison of pre- and post-intervention mean VAS scores of the loratadine control group and pre- and post-intervention mean VAS scores of the Ehretia Microphylla treatment group based on symptoms of sneezing, rhinorrhea, nasal congestion and pruritus showed significant improvement of symptoms in both groups (p-values of < .001).                         Conclusion: Ehretia microphylla (Tsaang Gubat) decoction tea may improve symptoms of allergic rhinitis (sneezing, rhinorrhea, pruritus, and nasal congestion) and be taken as an alternative to loratadine in patients with mild intermittent allergic rhinitis. Further clinical trials with more participants may provide stronger evidence for this conclusion.   Keywords: Allergic rhinitis, tsaang gubat, ehretia microphylla, loratadine    

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