scholarly journals Green tea intake and its effect on laboratory parameters and disease symptoms in hospitalised patients with Covid 19: a structured protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sara Mahmoodi ◽  
Mojtaba Yousefi ◽  
Omid Sadeghi ◽  
Ali Mahmoodabadi ◽  
Mohammadreza Sadriirani ◽  
...  

Abstract Objectives The current randomized controlled trial (RCT) will be conducted to assess the effect of green tea intake on disease symptoms and laboratory parameters including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and complete blood count (CBC) in patients with mild-to-moderate Covid-19 infection. Trial design Randomized, double-blinded, parallel (1:1 ratio) clinical trial exploratory study Participants We will recruit patients with COVID-19 infection admitted to Yasuj Shahid Jalil Hospital in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran. Participants’ inclusion criteria are as follows: Inclusion Criteria Patients aged ≥18 years COVID-19 diagnosis according to real-time polymerase chain reaction (RT-PCR) Exclusion Criteria Pregnancy or lactation Disseminated intravascular coagulation or any other types of coagulopathy Severe congestive kidney failure Having a history of participating in a clinical trial during the last 30 days Intervention and comparator Intervention: Two capsules containing 450 mg green tea extract along with routine treatment for COVID-19 patients in the intervention group. Two capsules containing placebo plus routine treatment for patients with COVID-19 infection. Capsules will be taken twice a day, after lunch and dinner, for 14 days. Main outcomes Changes in disease symptoms and laboratory parameters including CRP, ESR, and CBC after 14 days of the intervention compared to control group. Randomisation Eligible patients will be randomly assigned into the intervention or control group in a 1:1 ratio. Randomization will be performed based on 8 permuted blocks with block sizes of 10, and patients in the intervention and control groups will be matched according to sex and age categories. Randomization will be done using computer-generated random numbers (Randomization.com) Blinding (masking) The appearance of placebo and green tea capsules will be similar in terms of shape and color, and they will be packed in the same bags that will be prepared by the company. Also, the researcher and all participants will not be aware of the divisions until the end of the study. Numbers to be randomised (sample size) The total sample was determined based on CRP MCID in which high CRP levels were considered >2.6 mg/L. Accordingly, a total sample size of 37 patients for each intervention group was required. Trial Status The protocol is Version 1.0, on June 5, 2021. Recruitment will start on July 11, 2021, which is anticipated to be completed by September 21, 2021. Trial registration IRCT20150711023153N3 (https://www.irct.ir/trial/55948) retrospectively registered on June 4, 2021 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting was eliminated; this Letter serves as a summary of the key elements of the full protocol.

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Mehdi Hassaniazad ◽  
Ali Bazram ◽  
Soheil Hassanipour ◽  
Mohammad Fathalipour

Abstract Objectives We will evaluate the efficacy and safety of favipiravir and interferon beta-1a compared to lopinavir/ritonavir and interferon beta-1a in patients with confirmed COVID-19, who are moderately ill. Trial design This is a phase 3, single-center, randomized, open-label, controlled trial with a parallel-group design carried out at Shahid Mohammadi Hospital, Bandar Abbas, Iran. Participants All patients with age ≥ 20 years admitted at the Severe Acute Respiratory Syndrome Departments of the Shahid Mohammadi Hospital, Bandar Abbas, Iran, will be screened for the following criteria. Inclusion criteria: Confirmed diagnosis of infection with SARS-CoV-2 using polymerase chain reaction and/or antibody tests. Moderate COVID-19 pneumonia (via computed tomography and/or X-ray imaging), requiring hospitalization. Hospitalized ≤ 48 h. Signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm. Exclusion criteria: Underlying conditions, including chronic hepatitis, cirrhosis, cholestatic liver diseases, cholecystitis, peptic ulcers, acute and chronic renal failure, and peptic ulcers. Severe and critical COVID-19 pneumonia. History of allergy to favipiravir, lopinavir/ritonavir, and interferon beta-1a. Pregnancy and breastfeeding. Intervention and comparator Intervention group: favipiravir (Zhejiang Hisun, China) with interferon beta-1a (CinnaGen, Iran). This group will receive 1600 mg favipiravir twice a day for the first day and 600 mg twice a day for the following 4 days with five doses of 44 mcg interferon beta-1a every other day. Control group: lopinavir/ritonavir (Heterd Company, India) with interferon beta-1a (CinnaGen, Iran). This group will receive 200/50 mg lopinavir/ritonavir twice a day for 7 days with five doses of 44 mcg interferon beta-1a every other day. Other supportive and routine care will be the same in both groups. Main outcomes The primary outcome of the trial is the viral load of SARS-CoV-2 in the nasopharyngeal samples assessed by RT-PCR after 7 days of randomization as well as clinical improvement of fever and O2 saturation within 7 days of randomization. The secondary outcomes are the length of hospital stay and the incidence of serious adverse drug reactions within 7 days of randomization. Randomization Eligible patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 10 patients). A web-based system will be used to generate random numbers for the allocation sequence. Each number relates to one of the study arms. Blinding (masking) This is an open-label trial without blinding and placebo control. Numbers to be randomized (sample size) A total of 60 patients will be randomized into two groups (30 patients in the intervention group and 30 patients in the control group). Trial status The trial protocol is version 1.0, 22 July 2020. Recruitment began on 25 July 2020 and is anticipated to be completed by 25 September 2020. Trial registration Iranian Registry of Clinical Trials (IRCT) IRCT20200506047323N3. Registered on 22 July 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.


2019 ◽  
Vol 33 (8) ◽  
pp. 1391-1403 ◽  
Author(s):  
Ruth H Da-Silva ◽  
Sarah A Moore ◽  
Helen Rodgers ◽  
Lisa Shaw ◽  
Louise Sutcliffe ◽  
...  

Objective: To evaluate the feasibility of a multicentre, observer-blind, pilot randomized controlled trial (RCT) of a wristband accelerometer with activity-dependent vibration alerts to prompt impaired arm use after stroke. Design: Parallel-group pilot RCT. Setting: Four English stroke services. Participants: Patients 0–3 months post stroke with a new arm deficit. Intervention: Participants were randomized to wear a prompting or ‘sham’ wristband during a four-week self-directed therapy programme with twice-weekly therapy review. Main outcomes: Recruitment, retention and adherence rates, safety and completion of assessments were reported. Arm recovery was measured by Action Research Arm Test (ARAT) and Motor Activity Log (MAL) without statistical comparison. Results: In total, 33 patients were recruited (0.6 per month/site; median time post stroke: 26 days (interquartile range (IQR):15.5–45)). Baseline, four-week and eight-week median (IQR) ARAT for the control group ( n = 19) were 15 (2–35), 35 (15–26) and 31 (21–55) and those for the intervention group (n = 14) were 37 (16–45), 57 (29–57) and 57 (37–57), respectively; for MAL Amount of Use, the corresponding values in the control group were 0.2 (0.0–1.2), 1.1 (0.3–2.9) and 1.2 (0.7–2.9) and in the intervention group were 1.4 (0.5–2.6), 3.8 (1.9–4.5) and 3.7 (2.1–4.3). Four participants withdrew from the study. Wristbands were worn for 79% of the recommended time. The intervention and control group participants received a median of 6.0 (IQR: 4.3–8.0) and 7.5 (IQR: 6.8–8.0) therapy reviews. A median of 8 (IQR: 6–10) prompts were delivered per intervention participant/day. Research assessments were completed for 28/29 and 25/28 patients at four and eight weeks. Eight serious adverse events were reported, all unrelated to the intervention. Conclusion: A multicentre RCT of wristband accelerometers to prompt arm activity early after stroke is feasible. A total sample of 108 participants would be required.


2021 ◽  
Author(s):  
Sara Mahmoodi ◽  
Mojtaba Yousefi ◽  
Omid Sadeghi ◽  
Ali Mahmoodabadi ◽  
Mohammadreza Sadriirani ◽  
...  

Abstract ObjectivesThe current randomized controlled trial (RCT) will be conducted to assess the effect of green tea intake on disease symptoms and laboratory parameters including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and complete blood count (CBC) in patients with mild-to-moderate Covid-19 infection.Trial designRandomized, double-blinded, parallel (1:1 ratio) clinical trial exploratory study


2018 ◽  
Author(s):  
Musheer Abdulwahid Al-Jaberi ◽  
Muhamad Hanafiah Juni ◽  
Hayati Kadir Shahar ◽  
Siti Irma Fadhilah Ismail ◽  
Murad Abdu Saeed ◽  
...  

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i>&lt;.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;amp;EncHid=&amp;amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950


2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)


2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.


2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.


Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.


Author(s):  
K. Wernicke ◽  
J. Grischke ◽  
M. Stiesch ◽  
S. Zeissler ◽  
K. Krüger ◽  
...  

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Keivan Ranjbar ◽  
Mohsen Moghadami ◽  
Alireza Mirahmadizadeh ◽  
Mohammad Javad Fallahi ◽  
Vahid Khaloo ◽  
...  

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).


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