scholarly journals Efficacy of a Green Banana–Mixed Diet in the Management of Persistent Diarrhea: Protocol for an Open-Labeled, Randomized Controlled Trial

10.2196/15759 ◽  
2020 ◽  
Vol 9 (3) ◽  
pp. e15759 ◽  
Author(s):  
Monira Sarmin ◽  
Md Iqbal Hossain ◽  
Shoeb Bin Islam ◽  
Nur Haque Alam ◽  
Shafiqul Alam Sarker ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Hospital Costs ◽  
Case Fatality ◽  
Public Health Problem ◽  
Controlled Study ◽  
Persistent Diarrhea ◽  
Important Public Health Problem ◽  
Randomized Controlled ◽  
Full Strength ◽  
Green Banana

Background Diarrhea is the second-leading cause of death in children under 5 years of age. In low- and middle-income countries, 3%-20% of acute diarrheal episodes become persistent diarrhea (PD) (ie, duration ≥14 days), which results in 36%-56% of all diarrheal deaths. In Bangladesh, PD causes >25% of diarrhea-related deaths. Commensal gut microbiota dysbiosis is increasingly recognized in the pathogenesis of PD. Hospital-based management of PD requires a hospital stay, which increases the risk of infection and hospital costs. The higher cost of treatment and high case-fatality rates reiterate PD as an important public health problem. At the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), for the last two decades, a consensus-based guideline has been followed for PD. Observation has revealed that green banana helps in the resolution of diarrhea. However, no larger prospective study has been conducted to evaluate the efficacy of green banana in the management of PD among children older than 6 months of age. Objective Our objective is to assess the efficacy of full-strength rice suji with and without green banana compared to three-quarter-strength rice suji in the management of PD in children aged 6-36 months at the Dhaka Hospital of the icddr,b. Methods This open-labeled, randomized controlled study aims to enroll a total of 145 children with PD who have not been improving on a diet of milk suji. Children will be randomized into three different diet-specific groups: full-strength rice suji containing green banana, full-strength rice suji alone, and three-quarter-strength rice suji. The primary outcome is the percentage of children who recovered from diarrhea by day 5. Results Recruitment and data collection began in December 2017 and were completed in November 2019. Results are expected by April 2020. Conclusions This study is expected to provide insights into the incorporation of green banana into the dietary management of PD. This would be the first study to investigate the role of microbiota and metabolomics in the pathogenesis of PD. Trial Registration ClinicalTrials.gov NCT03366740; https://clinicaltrials.gov/ct2/show/NCT03366740 International Registered Report Identifier (IRRID) DERR1-10.2196/15759

Green Banana Mixed Diet is Beneficial in the Management of Childhood Persistent Diarrhea: An Open, Randomized-Controlled Trial

2021 ◽  
Author(s):  
Monira Sarmin ◽  
Md Iqbal Hossain ◽  
Shoeb Bin Islam ◽  
Shamima Sharmin Shikha ◽  
Md Nur Haque Alam ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Mixed Diet ◽  
Persistent Diarrhea ◽  
Randomized Controlled ◽  
Green Banana

Green Banana mixed Diet is Beneficial in the Management of Childhood Persistent Diarrhea: an Open, Randomized-Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Md Iqbal Hossain ◽  
Monira Sarmin ◽  
Shoeb Bin Islam ◽  
Shamima Sharmin Shikha ◽  
Md Nur Haque Alam ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Causal Link ◽  
Persistent Diarrhea ◽  
Death Studies ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Wide Range ◽  
Taqman Array ◽  
Green Banana

BACKGROUND Persistent diarrhea (PD), diarrhea for ≥14 days, accounts for 36%-56% of all diarrhea-related death. Studies demonstrated that green banana helps in the resolution of diarrhea. OBJECTIVE We assessed whether a lactose-free diet rice suji (RS) or rice suji containing green banana (GB-RS), improves outcome compared with 3/4th strength rice suji (3/4th RS) in 6 to 35 months old children having PD in the icddr,b Dhaka hospital. METHODS In this open-labeled, randomized, controlled trial, children with PD not improving with milk suji (the initial diet) received any of the three study diets: GB-RS, RS, 3/4th RS. The primary outcome was the percentage of children who recovered from diarrhea by day 5 with an intention to treat analysis. RESULTS From 1st December 2017 to 31st August 2019, we randomly allocated 45 children to each group. By day 5, 66 children recovered from PD, of whom 26 (58%), 14 (31%), 26 (58%) received GB-RS, RS, and 3/4th RS respectively. Significantly more resolution of PD occurred in GB-RS and 3/4th RS groups compared to RS group [relative risk (RR) 1⸱71, 95% CI 1⸱19-2⸱60; p=0⸱019]. Two (10%) children died, one each in RS group and GB-RS group. TaqMan array card (TAC) identified EAEC, rotavirus, norovirus, EPEC, astrovirus, and Campylobacter as the major pathogens associated with PD. CONCLUSIONS GB-RS and 3/4th RS are efficacious in the management of PD in young children. We also demonstrated a wide range of entero-pathogen associated with PD by TAC which needs further study to find a causal link. CLINICALTRIAL ClinicalTrials.gov, ID: NCT03366740 Registered on 8th December 2017 INTERNATIONAL REGISTERED REPORT RR2-10.2196/15759

scholarly journals Effectiveness of Community-Delivered Functional Power Training Program for Frail and Pre-frail Community-Dwelling Older Adults: a Randomized Controlled Study

2021 ◽  
Author(s):  
Nien Xiang Tou ◽  
Shiou-Liang Wee ◽  
Wei Ting Seah ◽  
Daniella Hui Min Ng ◽  
Benedict Wei Jun Pang ◽  
...  
Keyword(s):  
Older Adults ◽  
Muscle Strength ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Controlled Study ◽  
Power Training ◽  
Frail Older Adults ◽  
Frailty Status ◽  
Randomized Controlled ◽  
Community Dwelling Older Adults

AbstractTranslation of community-based functional training for older adults to reduce frailty is still lacking. We evaluated the effectiveness and implementation of a community-delivered group-based functional power training (FPT) program for frail older adults within their neighborhoods. A two-arm, multicenter assessor-blind stratified randomized controlled trial was conducted at four local senior activity centers in Singapore. Sixty-one community-dwelling older adults with low handgrip strength were randomized to intervention (IG) or control (CG) group. The IG underwent the FPT program (power and balance exercises using simple equipment) delivered by a community service provider. The 12-week program comprised 2 × 60 min sessions/week. CG continued usual activities at the centers. Functional performance, muscle strength, and frailty status were assessed at baseline and 3 months. Program implementation was evaluated using RE-AIM framework. The program was halted due to Coronavirus Disease 2019-related suspension of senior center activities. Results are reported from four centers, which completed the program. IG showed significantly greater improvement in the Short Physical Performance Battery test as compared to CG (p = 0.047). No effects were found for timed up and go test performance, muscle strength, and frailty status. The community program exhibited good reach, effectiveness, adoption, and implementation. Our study demonstrated that FPT was associated with greater improvement in physical function in pre-frail/frail participants as compared to exercise activities offered at local senior activity centers. It is a feasible intervention that can be successfully implemented for frail older adults in their neighborhoods. Trial registration ClinicalTrials.gov, NCT04438876. Registered 19 June 2020–retrospectively registered.

scholarly journals Efficacy of axial TheraTogs on gait pattern in children with dyskinetic cerebral palsy: a randomized controlled trial

2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Shamekh Mohamed El-Shamy ◽  
Ehab Mohamed Abd El Kafy
Keyword(s):  
Cerebral Palsy ◽  
Physical Therapy ◽  
Muscle Tone ◽  
Controlled Trial ◽  
Gait Pattern ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Gait Parameters ◽  
Experimental Group

Abstract Background TheraTogs promotes proprioceptive sense of a child with cerebral palsy and improves abnormal muscle tone, posture alignment, balance, and gait. Therefore, the aim of this study was to investigate the efficacy of TheraTogs orthotic undergarment on gait pattern in children with dyskinetic cerebral palsy. Thirty children with dyskinetic cerebral palsy were selected for this randomized controlled study. They were randomly assigned to (1) an experimental group that received TheraTogs orthotic undergarment (12 h/day, 3 days/week) plus traditional physical therapy for 3 successive months and (2) a control group that received only traditional physical therapy program for the same time period. Gait parameters were measured at baseline and after 3 months of intervention using Pro-Reflex motion analysis. Results Children in both groups showed significant improvements in the gait parameters (P < 0.05), with significantly greater improvements in the experimental group than in the control group. Conclusions The use of TheraTogs may have a positive effect to improve gait pattern in children with dyskinetic cerebral palsy. Trial registration This trial was registered in the ClinicalTrial.gov PRS (NCT03037697).

scholarly journals Transconjunctival versus Transcutaneous Injection of Botulinum Toxin into the Lacrimal Gland to Reduce Lacrimal Production: A Randomized Controlled Trial

Toxins ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 77
Author(s):  
Andrew G. Lee ◽  
Shin-Hyo Lee ◽  
Minsu Jang ◽  
Sang Jae Lee ◽  
Hyun Jin Shin
Keyword(s):  
Botulinum Toxin ◽  
Lacrimal Gland ◽  
Botulinum Toxin A ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Delivery Routes ◽  
Tear Meniscus Height

The purpose of this study was to determine and compare the effects between injecting botulinum toxin A (BTX-A) transconjunctivally into the palpebral lobe and transcutaneously into the orbital lobe of the lacrimal gland in patients with epiphora due to lacrimal outflow obstruction. This randomized controlled study included 53 eyes of 31 patients with unilateral or bilateral epiphora. Patients were randomly allocated to receive an injection of BTX-A (3 units) either transconjunctivally (n = 15, 25 eyes) or transcutaneously (n = 16, 28 eyes). For objective assessments, the tear meniscus height and Schirmer’s I test with topical anesthesia were measured at baseline and after 2, 6, 12, and 24 weeks of follow-up. Subjective evaluations were performed using the Munk score. After BTX-A injection, patients in both groups experienced significant objective and subjective reductions in tearing at all follow-up times compared to pre-injection (success rate 86.8%), and the effect lasted for a mean duration of 5.63 months. The two delivery routes showed similar clinical effectiveness for a single injected dose of BTX-A. In conclusion, injecting BTX-A via either a transconjunctival or transcutaneous route helps to reduce normal tear production and results in significant improvements in the symptoms in patients with epiphora.

scholarly journals Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial

ISRN Nursing ◽  
2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Paul Ratanasiripong ◽  
Nop Ratanasiripong ◽  
Duangrat Kathalae
Keyword(s):  
Nursing Students ◽  
Stress Level ◽  
Clinical Training ◽  
Intervention Program ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Moderate Increase ◽  
Randomized Controlled ◽  
The Impact

Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on how to use the biofeedback device to assist in stress and anxiety management for 5 weeks while the 30 in the control group did not receive any training. Findings. Results indicated that the biofeedback group was able to maintain the stress level while the control group had a significant increase in the stress level over the 5-week period of clinical training. Additionally, the biofeedback group had a significant reduction in anxiety, while the control group had a moderate increase in anxiety. Conclusions. The better the nursing students can manage their stress and anxiety, the more successful they can be in their clinical training. Ultimately, the more psychologically healthy the nursing students are, the more likely they will flourish and graduate to become productive and contributing members of the nursing profession.

scholarly journals Foam Rolling Elicits Neuronal Relaxation Patterns Distinct from Manual Massage: A Randomized Controlled Trial

2021 ◽  
Vol 11 (6) ◽  
pp. 818
Author(s):  
Yann Kerautret ◽  
Aymeric Guillot ◽  
Sébastien Daligault ◽  
Franck Di Rienzo
Keyword(s):  
Skin Conductance ◽  
Muscle Pain ◽  
Controlled Trial ◽  
Muscle Relaxation ◽  
Well Being ◽  
Self Report ◽  
Controlled Study ◽  
Control Group ◽  
Foam Rolling ◽  
Randomized Controlled

The present double-blinded, randomized controlled study sought to compare the effects of a full-body manual massage (MM) and a foam rolling (FR) intervention on subjective and objective indexes of performance and well-being. A total of 65 healthy individuals were randomly allocated to an FR, MM, or a control group who received a cognitively oriented relaxation routine. Self-report ratings of perceived anxiety, muscle relaxation, and muscle pain were used to index changes in affect and physical sensations. The sit-and-reach and toe-touch tests, as well as a mental calculation task, were used to index motor and cognitive performances, respectively. We also conducted resting-state electroencephalography and continuous skin conductance recordings before and after the experimental intervention. Both FR and MM groups exhibited neural synchronization of alpha and beta oscillations during the posttest. Skin conductance increased from the pretest to the posttest in the relaxation group, but decreased in the FR group. All interventions improved range of motion, although only the MM group outperformed the relaxation group for the toe-touch performance. MM was associated with reduced muscle pain and increased muscle relaxation. Reduced perceived anxiety after the intervention was observed in the FR group only. Overall, MM and FR both improved objective and subjective indexes of performance and well-being. Differences between the two massage interventions are discussed in relation to the effects of pressure stimulation on autonomic regulations and the proactive vs. retroactive nature of FR, compared to MM.

The effect of administration of 17-OH progesterone intramascular on the latency of pregnancy in primegravida with singleton pregnancy and prelabour rupture of membrane (PPROM) (Randomized Controlled Trial)

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Ihab Hassan Abdel Fattah ◽  
Mohamed Mahmoud Abdel Allim ◽  
MortadaElsayed Ahmed ◽  
Yasmeen Ahmed Mohamed Taha
Keyword(s):  
Preterm Delivery ◽  
Gestational Age ◽  
Statistical Power ◽  
Controlled Trial ◽  
Maternity Hospital ◽  
Lower Percentage ◽  
Controlled Study ◽  
Premature Delivery ◽  
Singleton Pregnancy ◽  
Randomized Controlled

Abstract Background Preterm delivery with its associated morbidity and mortality still represents one of the major unsolved problems in Obstetrics. In PPROM, there is an increased incidence of preterm delivery which represents a life threatening situation. It has been calculated that the mean duration of PROM pregnancies is 37 weeks, so premature birth defined as delivery before 37 week of gestation, is the leading cause of perinatal mortality and short and long term fetal morbidity. Obviously, preterm deliveries represent a problem because of the severe neonatal complications that often occur afterwards. These complications are worse for the smaller newborn with earlier gestational age. These complications include respiratory distress syndrome, intraventricular hemorrhage, sepsis and necrotizing enterocolitis. Objective The present study aims to investigate the effect of 17-OH progesterone on primegravida and the possible change in the premature delivery rates and other pregnancy outcomes and complications regarding its use. Methods The current research is a randomized controlled study was conducted at Obstetric outpatient clinic of Ain Shams University Maternity Hospital and involved 80 pregnant admitted to assess the efficacy of intramuscular progesterone compared to placebo therapy in decreasing the rate of preterm birth in women with PPROM pregnancy, selected on basis being with age between 18-35 years, carrying Singleton pregnancy, at gestational age between24-34 weeks. Results The present study provides no evidence that 17OHP-C is beneficial in women with PROM. Although the trial turned out to be underpowered for the primary outcome, it had reasonable statistical power for the prespecified secondary outcomes, which allowed us to conclude that 17OHP-C does not prolong pregnancy or reduce perinatal morbidity after PROM. Preterm PROM is a frequently encountered obstetric diagnosis, with improved neonatal outcomes when an uninfected mother is able to continue her pregnancy for a longer duration to reach a more advanced gestational age. Conclusion Compared placebo with intramuscular 17-OHPC in women with prelabour rupture of membranes. Pregnancy is associated with lower percentage of preterm labour, fewer NICU admissions in 17 OHPC.

scholarly journals The effects of ankle-foot orthoses with plantar flexion stop and plantar flexion resistance using rocker-sole shoes on stroke gait: A randomized-controlled trial

2021 ◽  
Vol 67 (4) ◽  
pp. 449-461
Author(s):  
Aliyeh Daryabor ◽  
Gholamreza Aminian ◽  
Mokhtar Arazpour ◽  
Mina Baniasad ◽  
Sumiko Yamamoto
Keyword(s):  
Controlled Trial ◽  
Plantar Flexion ◽  
Three Dimensional ◽  
Chronic Phase ◽  
Controlled Study ◽  
Foot Orthoses ◽  
Randomized Controlled ◽  
Ankle Foot Orthoses ◽  
Spatiotemporal Parameters ◽  
Single Support Phase

Objectives: This study aims to evaluate the effect of two ankle-foot orthoses (AFOs), AFO with plantar flexion stop (AFO-PlfS), and AFO with plantar flexion resistance (AFO-PlfR), while wearing standard shoes and rocker-sole shoes. Patients and methods: Between November 2017 and July 2018, in this randomized-controlled study, a total of 20 stroke patients (8 males, 12 females; mean age: 48.1 years; range, 33 to 65 years) in chronic phase were randomized to AFO groups (AFO-PlfS group, n=10 and AFO-PlfR group, n=10). Each group received the allocated AFO along with two kinds of shoes (standard shoe and rocker shoe) for a two-week adaptation. Two effects were separately evaluated: The orthotic effect and rocker shoe effect were defined as the evaluation of using an AFO wearing standard shoe compared to only standard shoe, and evaluation of using an AFO wearing rocker shoe compared to an AFO wearing standard shoe, respectively. The gait of each group was measured by three-dimensional motion analysis. Results: A significant orthotic effect was found in both AFO groups in spatiotemporal parameters and maximum ankle dorsiflexion in the single-support phase. Additionally, the AFO-PlfR group showed a significant improvement in the parameters related to the first rocker of gait, but not for AFO-PlfS group concerning the orthotic effect. The rocker shoe effect was found in significant reduction of peak ankle plantar flexor moment and power ankle generation during preswing for both AFO groups. Conclusion: According to the orthotic effect, an AFO-PlfR can create better function in the improvement of parameters related to the first rocker. Although a rocker shoe can facilitate rollover for weight progression in the third rocker of gait, it cannot make a strong push-off function in stroke survivors.

scholarly journals EVALUATION OF EFFECTIVENESS OF AROGYA KASHAYAM-20 IN COVID-19 CASES - A RANDOMIZED CONTROLLED STUDY

2021 ◽  
Author(s):  
Umesh Shukla ◽  
Nitin Ujjaliya
Keyword(s):  
Controlled Trial ◽  
Care Center ◽  
Large Population ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Rt Pcr ◽  
Randomized Controlled ◽  
Group A ◽  
Negative Conversion

Introduction: The characteristic clinical features of Covid-19 disease range between asymptomatic to mild-moderate symptoms. Studies suggest that a large population (80%) presents its asymptomatic or milder form. Remaining 20 percent, owing to severity of the diseases, need hospital-based care. Many treatment protocols and strategies have been promoted and recommended by authorities including WHO, but nothing has actually been finalized till date. The present study was planned to evaluate the effectiveness of an Ayurvedic formulation viz. Arogya Kashayam-20 in the hospitalized cases of Covid-19.Aim: To evaluate the effectiveness of Arogya Kashayam-20 in the cases of COVID-19 particularly the negative conversion of RTPCR in 10 days duration.Material and Methods: This was a randomized controlled trial conducted at COVID-19 Care Center, Pt. Khushilal Sharma Government Ayurveda College &amp; Institute, Bhopal, Madhya Pradesh with a sample size of 112 participants, aged between 16 to 60 years of either sex. Participants were divided in two groups viz. group A and B. Both the groups received Hydroxychloroquine (HCQ), vitamin C and Zinc as per the prevailing ICMR guidelines and group 'A' received additionally Arogya Kashayam-20 for 10 days. Outcome measure of the study was to see the negative conversion RT-PCR test after intervention period of 10 days. CTRI Registration: CTRI/2020/06/026221. Results: Among the 60 cases registered in study group (group A), 51 cases (85.00%) were reported with negative RTPCR on 10th day. Out of 52 cases registered in control group (group B); 39 cases (75.00%) were tested negative RTPCR on 10th day. In both the groups all the cases were discharged asymptomatically on 10th day as per the prevailing ICMR guidelines. No ADR/AE observed during the intervention period.Conclusion: The study observes that the add on intervention group has a better outcome in terms of RT-PCR negative reports after 10 days comparing to the control group.

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