AYUSH medicine as add-on therapy for mild category COVID-19; an open label randomised, controlled clinical trial

AbstractBackgroundAYUSH formulations have a potential role in symptomatic treatment, preventing disease progression and improving quality of life in COVID-19 patients.ObjectiveTo study the effect of AYUSH formulation (Kabasura Kudineer tablets, Shakti drops and Turmeric plus) as an add-on treatment in patients with mild COVID - 19MethodologySingle centre, two arms, open labelled randomized controlled trial with a total of 30 patients (15 in the intervention arm and 15 in the standard care arm). Intervention arm received a combination of 3 AYUSH formulation along with the standard of care treatment for 21 days. All patients were followed for 28 days. Symptom severity (using Modified Jackson scale), negative conversion of SARS-CoV-2 RNA (using RTPCR) and quality of life (WHOWOL BREF questionnaire) was assessed.ResultsFifteen patients (93.8%) in the intervention group and twelve patients (92.3%) in the standard care arm had complete resolution of symptoms (P value= 0.36). Negative conversion for SARS-CoV-2 was seen in thirteen patients (92.9%) in intervention arm and eleven patients (100%) in standard care arm at day 28 (P value = 0.56). There was no difference in the quality of life scores between the 2 groups.ConclusionThe use of Ayush interventions as add-on therapy did not negatively impact the clinical outcomes in COVID-19. This trial confirmed the safety and tolerability of Kabasura Kudineer tablets, Shakti drops and Turmeric plus tablets when used use among mild to moderate symptom category, of COVID-19. There were no serious adverse events in the treated group. There was no clinical progression of disease from baseline status and all trial participants recovered fully by day 28. A longer follow up and a larger sample size is recommended for future definitive trials with this alternative medicine (AYUSH) combination.

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Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial

JMIR Nursing ◽

10.2196/20747 ◽

2020 ◽

Vol 3 (1) ◽

pp. e20747

Author(s):

Mahboube Davoudi ◽

Tahereh Najafi Ghezeljeh ◽

Farveh Vakilian Aghouee

Keyword(s):

Quality Of Life ◽

Heart Failure ◽

Clinical Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Patients With Heart Failure

Background Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. Objective The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. Methods This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. Results The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). Conclusions Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. Trial Registration Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

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Prevention of adverse drug reactions in hospitalized older patients with multi-morbidity and polypharmacy: the SENATOR* randomized controlled clinical trial

Age and Ageing ◽

10.1093/ageing/afaa072 ◽

2020 ◽

Vol 49 (4) ◽

pp. 605-614 ◽

Cited By ~ 8

Author(s):

Denis O'Mahony ◽

Adalsteinn Gudmundsson ◽

Roy L Soiza ◽

Mirko Petrovic ◽

Alfonso Jose Cruz-Jentoft ◽

...

Keyword(s):

Adverse Drug Reactions ◽

Primary Endpoint ◽

Standard Care ◽

Controlled Trial ◽

Intervention Group ◽

Controlled Clinical Trial ◽

Drug Reactions ◽

Open Label ◽

Related Quality ◽

Health Related

Abstract Background Multi-morbidity and polypharmacy increase the risk of non-trivial adverse drug reactions (ADRs) in older people during hospitalization. Despite this, there are no established interventions for hospital-acquired ADR prevention. Methods We undertook a pragmatic, multi-national, parallel arm prospective randomized open-label, blinded endpoint (PROBE) controlled trial enrolling patients at six European medical centres. We randomized 1,537 older medical and surgical patients with multi-morbidity and polypharmacy on admission in a 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n = 772, mean number of daily medications = 9.34) or standard care alone (control, n = 765, mean number of daily medications = 9.23) using block randomization stratified by site and admission type. Attending clinicians in the intervention arm received SENATOR-generated advice at a single time point with recommendations they could choose to adopt or not. The primary endpoint was occurrence of probable or certain ADRs within 14 days of randomization. Secondary endpoints were primary endpoint derivatives; tertiary endpoints included all-cause mortality, re-hospitalization, composite healthcare utilization and health-related quality of life. Results For the primary endpoint, there was no difference between the intervention and control groups (24.5 vs. 24.8%; OR 0.98; 95% CI 0.77–1.24; P = 0.88). Similarly, with secondary and tertiary endpoints, there were no significant differences. Among attending clinicians in the intervention group, implementation of SENATOR software-generated medication advice points was poor (~15%). Conclusions In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.

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Effects of Helichrysum Psudoplicatum supplementation on pruritus intensity, fatigue, quality of life and anorexia in hemodialysis patients: a randomized, double-blind placebo-controlled trial

Hormone Molecular Biology and Clinical Investigation ◽

10.1515/hmbci-2021-0015 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Maryam Mohajeranirad ◽

Naser Saeidi ◽

Mohammad Kamali Nejad ◽

Amir Almasi-Hashiani ◽

Mehdi Salehi ◽

...

Keyword(s):

Quality Of Life ◽

Rating Scale ◽

Controlled Trial ◽

Intervention Group ◽

Controlled Clinical Trial ◽

Dialysis Patients ◽

Time Duration ◽

Double Blind ◽

Double Blind Placebo

Abstract Objectives Anorexia, fatigue and pruritus are common complications of hemodialysis (HD) patients. Today, the use of medicinal plants is more than synthetic drugs due to their safety. Therefore, we designed a randomized controlled clinical trial to evaluate the effects of Helichrysum psudoplicatum (H. psudoplicatum) supplementation on biochemical parameters, pruritus intensity, fatigue, quality of life and anorexia in HD patients. Methods This randomized, double-blind, placebo-controlled trial was performed on 50 subjects with, aged 55–65 years old. HD patients were randomly divided into two groups. Intervention group received 250 mg/day of H. psudoplicatum supplement capsule for 6 weeks (n=25), and the placebo group was given placebo capsule for the same time duration and dosage (n=25). The serum concentrations of urea, creatinine, albumin and hemoglobin were measured enzymatically methods. Anorexia, pruritus intensity, quality of life the dialysis patients with pruritus and fatigue score was measured using a Simplified Nutritional Appetite Questionnaire (SNAQ), Numerical rating scale (NRS), Fatigue severity scale (FSS) and ItchyQoL questionnaire, respectively. Shapiro–Wilk and independent-samples t-test or Mann–Whitney test were used for the analysis of the data. Results The results showed that the H. psudoplicatum supplementation significantly improved the pruritus intensity, quality of life the dialysis patients with pruritus and fatigue in HD patients, for 6 weeks (p<0.001). However, it did not significantly effect on the anorexia, albumin, hemoglobin, urea, creatinine, arm circumference, and body mass index (p>0.05). Conclusions According to the results of this study, H. psudoplicatum supplementation can be effective as an adjunct therapy to improve pruritus intensity, quality of life, fatigue and relative improvement of anorexia in HD patients.

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Hippotherapy for patients with multiple sclerosis: A multicenter randomized controlled trial (MS-HIPPO)

Multiple Sclerosis Journal ◽

10.1177/1352458517721354 ◽

2017 ◽

Vol 24 (10) ◽

pp. 1375-1382 ◽

Cited By ~ 10

Author(s):

Vanessa Vermöhlen ◽

Petra Schiller ◽

Sabine Schickendantz ◽

Marion Drache ◽

Sabine Hussack ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Standard Care ◽

Controlled Trial ◽

Intervention Group ◽

Mean Difference ◽

Control Group ◽

Health Score ◽

Multicenter Randomized Controlled Trial

Background: Evidence-based complementary treatment options for multiple sclerosis (MS) are limited. Objective: To investigate the effect of hippotherapy plus standard care versus standard care alone in MS patients. Methods: A total of 70 adults with MS were recruited in five German centers and randomly allocated to the intervention group (12 weeks of hippotherapy) or the control group. Primary outcome was the change in the Berg Balance Scale (BBS) after 12 weeks, and further outcome measures included fatigue, pain, quality of life, and spasticity. Results: Covariance analysis of the primary endpoint resulted in a mean difference in BBS change of 2.33 (95% confidence interval (CI): 0.03–4.63, p = 0.047) between intervention ( n = 32) and control ( n = 38) groups. Benefit on BBS was largest for the subgroup with an Expanded Disability Status Scale (EDSS) ⩾ 5 (5.1, p = 0.001). Fatigue (−6.8, p = 0.02) and spasticity (−0.9, p = 0.03) improved in the intervention group. The mean difference in change between groups was 12.0 ( p < 0.001) in physical health score and 14.4 ( p < 0.001) in mental health score of Multiple Sclerosis Quality of Life-54 (MSQoL-54). Conclusion: Hippotherapy plus standard care, while below the threshold of a minimal clinically important difference, significantly improved balance and also fatigue, spasticity, and quality of life in MS patients.

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Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial (Preprint)

10.2196/preprints.20747 ◽

2020 ◽

Author(s):

Mahboube Davoudi ◽

Tahereh Najafi Ghezeljeh ◽

Farveh Vakilian Aghouee

Keyword(s):

Quality Of Life ◽

Heart Failure ◽

Clinical Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Patients With Heart Failure

BACKGROUND Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. OBJECTIVE The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. METHODS This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. RESULTS The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). CONCLUSIONS Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. CLINICALTRIAL Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

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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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Effectiveness of Wet Cupping on Patients with Facial Acne Vulgaris: A 12-Week, Randomized, Single-Blind, Intervention-Sham-Controlled Trial

Complementary Medicine Research ◽

10.1159/000514943 ◽

2021 ◽

pp. 1-8

Author(s):

Fatemeh Tabatabaei ◽

Mehdi Pasalar ◽

Haleh Tajadini ◽

Mohadese Kamali ◽

Thomas Rampp

Keyword(s):

Quality Of Life ◽

Antibiotic Therapy ◽

Controlled Trial ◽

Acne Vulgaris ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Single Blind ◽

Facial Acne

Introduction: Acne vulgaris is a widespread skin disorder. The aim of this study was to assess the effectiveness of wet cupping in the treatment of moderate to severe facial acne vulgaris. Methods: Between August 2018 and January 2020, eligible patients with moderate to severe facial acne were recruited in this single-blind, intervention-sham-controlled clinical trial in Iran. The intervention group received wet cupping twice and likewise the control group received sham cupping. Also, both groups received 500 mg azithromycin 3 times/week for 12 weeks. Acne grades were assessed 6 weeks and 12 weeks after beginning of the treatment by the dermatologist uninformed of group allocation and participant self-assessment. Quality of life was assessed with valid questionnaire before and after the treatment. Result: Totally, 103 patients completed the trial. The patients in the intervention group had better improvement and grade of acne compared to the control group at the end of the trial. Patients showed a shorter time to removing facial lesions in the intervention group in contrast with the control group (p < 0.001). Quality of life significantly increased in the intervention group compared with the control group (p = 0.004). Conclusion: Wet cupping plus antibiotic therapy seems to be more effective than antibiotic therapy per se in patients with facial acne vulgaris.

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Impact of a mobile application for tracking nausea and vomiting during pregnancy (NVP) on NVP symptoms, quality of life, and decisional conflicts regarding NVP treatments: the MinSafeStart randomized controlled trial (Preprint)

10.2196/preprints.36226 ◽

2022 ◽

Author(s):

Elin Ngo ◽

Maria Bich-Thuy Truong ◽

Hedvig Nordeng ◽

David Wright

Keyword(s):

Quality Of Life ◽

Pregnant Women ◽

Maternal Care ◽

Mobile Application ◽

Standard Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled

BACKGROUND Pregnant women are active users of mobile applications (app) for health purposes. These apps may improve self-management of health-related conditions. Up to 70% of pregnant women experience nausea and vomiting (NVP). Even mild NVP can significantly reduce the quality of life (QoL), and it can become an economic burden for both the woman and society. NVP often occurs before the first maternal care visit; therefore, apps can potentially play an important role in empowering pregnant women to recognize, manage, and seek appropriate treatment for NVP, when required. OBJECTIVE This study investigated whether the MinSafeStart mobile application (MSS app) could impact NVP-related symptoms, QoL, and decisional conflicts regarding NVP treatment. METHODS This randomized controlled trial enrolled 222 pregnant women with NVP in Norway from 2019-2020. The intervention group had access to the MSS app, which could be used to track NVP symptoms and access tailored advice. NVP severity was rated with the Pregnancy Unique Quantification of Emesis (PUQE) score. The control group followed standard maternal care. We collected data on maternal baseline characteristics, NVP severity, QoL, and decisional conflicts with two sets of online questionnaires. One set of questionnaires was completed at enrollment, and the other was completed after two weeks. We performed linear regression analyses to explore whether the use of the MSS app was associated with NVP severity, QoL, or decisional conflicts. RESULTS Among the 222 women enrolled in the study, 192 (86.5%) completed the baseline questionnaires and were randomized to either the intervention (n=89) or the control group (n=103). In the intervention group, 88 women downloaded the app, and 468 logs were recorded. In both groups, women were enrolled at a median of 8 gestational weeks. At baseline, the average PUQE scores were 4.9 and 4.7; the average QoL scores were 146 and 149; and the average decisional conflict scores were 40 and 43, in the intervention and control groups, respectively. The app had no impact on NVP severity (aβ: 0.6, 95% Cl: -0.1, 1.2), QoL (aβ: -5.3; 95% Cl: -12.5, 1.9), or decisional conflicts regarding NVP treatment (aβ: -1.1, 95% Cl -6.2, 4.2), compared to standard care. CONCLUSIONS Tracking NVP symptoms with the MSS app was not associated with improvements in NVP symptoms, QoL, or decisional conflicts after two weeks, compared to standard care. Future studies should include a process evaluation to improve our understanding of how pregnant women use the app and how to optimize its utility within maternity care. Specifically, studies should focus on how digital tools might facilitate counseling and communication between pregnant women and health care providers, regarding NVP management during pregnancy. CLINICALTRIAL This trial was registered at ClinicalTrails.gov (identifier: NCT04719286, registration date: January 22, 2021).

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Measuring the Effects of an Animal-Assisted Intervention for Pediatric Oncology Patients and Their Parents: A Multisite Randomized Controlled Trial

Journal of Pediatric Oncology Nursing ◽

10.1177/1043454217748586 ◽

2017 ◽

Vol 35 (3) ◽

pp. 159-177 ◽

Cited By ~ 17

Author(s):

Amy McCullough ◽

Ashleigh Ruehrdanz ◽

Molly A. Jenkins ◽

Mary Jo Gilmer ◽

Janice Olson ◽

...

Keyword(s):

Quality Of Life ◽

Standard Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Group Randomized Trial ◽

Related Quality ◽

Treatment Measures ◽

Animal Assisted Intervention

Objective: This multicenter, parallel-group, randomized trial examined the effects of an animal-assisted intervention on the stress, anxiety, and health-related quality of life for children diagnosed with cancer and their parents. Method: Newly diagnosed patients, aged 3 to 17 years (n = 106), were randomized to receive either standard care plus regular visits from a therapy dog (intervention group), or standard care only (control group). Data were collected at set points over 4 months of the child’s treatment. Measures included the State-Trait Anxiety Inventory™, Pediatric Quality of Life Inventory, Pediatric Inventory for Parents, and child blood pressure and heart rate. All instruments were completed by the child and/or his/her parent(s). Results: Children in both groups experienced a significant reduction in state anxiety ( P < .001). Parents in the intervention group showed significantly decreased parenting stress ( P = .008), with no changes in stress among parents in the control group. However, no significant differences between groups over time on any measures were observed. Conclusions: Animal-assisted interventions may provide certain benefits for parents and families during the initial stages of pediatric cancer treatment.

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Effects of Mobility-Enhancing Nursing Intervention in Patients with MS and Stroke: Randomised Controlled Trial

International Scholarly Research Notices ◽

10.1155/2015/785497 ◽

2015 ◽

Vol 2015 ◽

pp. 1-6 ◽

Cited By ~ 4

Author(s):

Lorenz Imhof ◽

Susanne Suter-Riederer ◽

Jürg Kesselring

Keyword(s):

Quality Of Life ◽

Self Efficacy ◽

Standard Care ◽

Controlled Trial ◽

Intervention Group ◽

Nursing Intervention ◽

Control Group ◽

Rehabilitation Outcomes ◽

Main Effect

Background. Multiple sclerosis (MS) or stroke causes functional impairment which can have a major impact on patients’ life. Objectives. This RCT investigated the effect of a new nursing intervention (Mobility Enhancing Nursing Intervention—MFP) designed to improve rehabilitation outcomes. Method. The study took place in a rehabilitation clinic in Switzerland. One hundred forty participants diagnosed with MS, stroke, and brain injuries were randomly assigned to control group (CG = standard care) or intervention group (IG). The IG combined standard care with 30 days of MFB. MFP placed patients on a mattress on the floor and used tactile-kinaesthetic stimulation to increase spatial orientation and independency. Outcomes were functionality (Extended Barthel Index, EBI), quality of life (WHOQoL), and fall-related self-efficacy (FES-I). Results. There was a significant main effect of the intervention on functionality (EBI-diff/day mean = 0.30, versus mean = 0.16, P=0.008). There was also a significant main effect on QoL (WHOQoL-diff mean = 13.8, versus mean = 5.4, P=0.046). No significant effect was observed on fall-related self-efficacy. Conclusions. The positive effect of MFP on rehabilitation outcomes and quality of life suggests that this specialized nursing intervention could become an effective part of rehabilitation programs. The study was approved by the Ethics Committee of St. Gallen (KEK-SG Nr. 09/021) and registered at ClinicalTrial.gov NCT02198599.

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