Recent Submissions

  • Patients’ experiences of cannulation of arteriovenous access for haemodialysis: A qualitative systematic review

    Fielding, Catherine; Toft, Suzanne
    Introduction: Cannulation is an essential part of haemodialysis with arteriovenous access. Patients’ experiences of cannulation for haemodialysis are problematic but poorly understood. This review aims to synthesise findings related to patients’ experiences of cannulation for haemodialysis from qualitative studies, providing a fuller description of this phenomenon. Methods: Eligibility criteria defined the inclusion of studies with a population of patients with end-stage kidney disease on haemodialysis. The phenomena of interest was findings related to patients’ experiences of cannulation for haemodialysis and the context was both in-centre and home haemodialysis. MedLine, CINAHL, EMBASE, EMCARE, BNI, PsycInfo and PubMed were last searched between 20/05/2019 and 23/05/2019. The quality of studies was assessed using the using Joanna Briggs Critical Appraisal Checklist for Qualitative Research. Meta-aggregation was used to synthesise findings and CERQual to assess the strength of accumulated findings. Results: This review included 26 studies. The subject of included studies covered cannulation, pain, experiences of vascular access, experiences of haemodialysis and a research priority setting exercise. From these studies, three themes were meta-aggregated: (1) Cannulation for haemodialysis is an unpleasant, abnormal and unique procedure associated with pain, abnormal appearance, vulnerability and dependency. (2) The necessity of cannulation for haemodialysis emphasises the unpleasantness of the procedure. Success had multiple meanings for patients and patients worry about whether the needle insertion will be successful. (3) Patients survive unpleasant, necessary and repetitive cannulation by learning to tolerate cannulation and exerting control over the procedure. Feeling safe can help them tolerate cannulation better and the cannulator can invoke feeling safe. However, some patients still avoid cannulation, due to its unpleasantness. Conclusions: Cannulation is a pervasive procedure that impacts on patients’ experiences of haemodialysis. This review illuminates further patients’ experiences of cannulation for haemodialysis, indicating how improvements can be made to cannulation. Registration: PROSPERO (CRD42019134583)
  • Effect of institution volume on mortality and outcomes in osteoporotic hip fracture care

    Johnson, NA (2022-01)
    Hospitals that treat more patients with osteoporotic hip fractures do not generally have better care outcomes than those that treat fewer hip fracture patients. Institutions that do look after more such patients tend, however, to more consistently perform relevant health assessments. INTRODUCTION: An inveterate link has been found between institution case volume and a wide range of clinical outcomes; for a host of medical and surgical conditions. Hip fracture patients, notwithstanding the significance of this injury, have largely been overlooked with regard to this important evaluation. METHODS: We used the UK National Hip Fracture database to determine the effect of institution hip fracture case volume on hip fracture healthcare outcomes in 2019. Using logistic regression for each healthcare outcome, we compared the best performing 50 units with the poorest performing 50 institutions to determine if the unit volume was associated with performance in each particular outcome. RESULTS: There were 175 institutions with included 67,673 patients involved. The number of hip fractures between units ranged from 86 to 952. Larger units tendered to perform health assessments more consistently and mobilise patients more expeditiously post-operatively. However, patients treated at large institutions did not have any shorter lengths of stay. With regard to most other outcomes there was no association between the unit number of cases and performance; notably mortality, compliance with best practice tariff, time to surgery, the proportion of eligible patients undergoing total hip arthroplasty, length of stay delirium risk and pressure sore risk. CONCLUSIONS: There is no relationship between unit volume and the majority of health care outcomes. It would seem that larger institutions tend to perform better at parameters that are dependent upon personnel numbers. However, where the outcome is contingent, even partially, on physical infrastructure capacity, there was no difference between larger and smaller units.
  • Management of Retraction Pockets: historic and novel approaches.

    Spinos, Dimitrios; Mallick, Sameer; Judd, Owen
  • Cervical arthroplasty in a professional kick-boxing fighter, 7 years follow-up.

    Klezl, Zdenek
    Spinal surgery in professional athletes is a topic of much discussion. Anterior cervical discectomy and fusion (ACDF) is the standard procedure used by surgeons, and other techniques used to treat athletes includes foraminotomies, laminoplasties and total disc replacement. Total disc replacement is an unusual technique used to treat athletes in general and is becoming a more important issue in full contact sports. This case report illustrates a 34 years old professional fighter that suffered a cervical injury that evolved with cervical axial pain and irradiated pain and numbness. She was submitted to total disc replacement (TDR) at the C5-6 level, returning to competitive sports after and with a seven-year follow-up. To the date she remains symptom free and besides having an anterior foramen, the spine was able to keep movement at that level. TDR may be a safe and trustworthy technique when treating elite athletes.
  • Mentorship in Dermatology-A Beginner's Guide

    Narang, I
    Mentoring albeit is a recently described and popular phenomenon in medicine, is not a new one. All medical specialties have a complex, intertwined relationship between their physicians and trainees who are in different stages of their careers. How a specialty evolves depends on the thread woven by these relationships. This article outlines the concept of mentorship and introduces its various aspects in dermatology. This article attempts to answer what, why, how, when, and where related to mentoring in dermatology, including e-mentorship. The article also includes personal reflections of the authors who are involved in this process
  • Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol.

    Das, P
    BACKGROUND: Men with high-risk non-metastatic prostate cancer are treated with androgen-deprivation therapy (ADT) for 3 years, often combined with radiotherapy. We analysed new data from two randomised controlled phase 3 trials done in a multiarm, multistage platform protocol to assess the efficacy of adding abiraterone and prednisolone alone or with enzalutamide to ADT in this patient population. METHODS: These open-label, phase 3 trials were done at 113 sites in the UK and Switzerland. Eligible patients (no age restrictions) had high-risk (defined as node positive or, if node negative, having at least two of the following: tumour stage T3 or T4, Gleason sum score of 8-10, and prostate-specific antigen [PSA] concentration ≥40 ng/mL) or relapsing with high-risk features (≤12 months of total ADT with an interval of ≥12 months without treatment and PSA concentration ≥4 ng/mL with a doubling time of <6 months, or a PSA concentration ≥20 ng/mL, or nodal relapse) non-metastatic prostate cancer, and a WHO performance status of 0-2. Local radiotherapy (as per local guidelines, 74 Gy in 37 fractions to the prostate and seminal vesicles or the equivalent using hypofractionated schedules) was mandated for node negative and encouraged for node positive disease. In both trials, patients were randomly assigned (1:1), by use of a computerised algorithm, to ADT alone (control group), which could include surgery and luteinising-hormone-releasing hormone agonists and antagonists, or with oral abiraterone acetate (1000 mg daily) and oral prednisolone (5 mg daily; combination-therapy group). In the second trial]
  • Redefining WILD syndrome: a primary lymphatic dysplasia with congenital multisegmental lymphoedema, cutaneous lymphovascular malformation, CD4 lymphopaenia and warts.

    Keeley, Vaughan (2021-12)
    BACKGROUND: Primary lymphoedema (PL) syndromes are increasingly recognised as presentations of complex genetic disease, with at least 20 identified causative genes. Recognition of clinical patterns is key to diagnosis, research and therapeutics. The defining criteria for one such clinical syndrome, 'WILD syndrome' (Warts, Immunodeficiency, Lymphoedema and anogenital Dysplasia), have previously depended on a single case report. METHODS AND RESULTS: We present 21 patients (including the first described case) with similar clinical and immunological phenotypes. All had PL affecting multiple segments, with systemic involvement (intestinal lymphangiectasia/pleural or pericardial effusions) in 70% (n=14/20). Most (n=20, 95%) had a distinctive cutaneous lymphovascular malformation on the upper anterior chest wall. Some (n=10, 48%) also had hyperpigmented lesions resembling epidermal naevi (but probably lymphatic in origin). Warts were common (n=17, 81%) and often refractory. In contrast to the previous case report, anogenital dysplasia was uncommon-only found in two further cases (total n=3, 14%). Low CD4 counts and CD4:CD8 ratios typified the syndrome (17 of 19, 89%), but monocyte counts were universally normal, unlike GATA2 deficiency. CONCLUSION: WILD syndrome is a previously unrecognised, underdiagnosed generalised PL syndrome. Based on this case series, we redefine WILD as 'Warts, Immunodeficiency, andLymphatic Dysplasia' and suggest specific diagnostic criteria. The essential criterion is congenital multisegmental PL in a 'mosaic' distribution. The major diagnostic features are recurrent warts, cutaneous lymphovascular malformations, systemic involvement (lymphatic dysplasia), genital swelling and CD4 lymphopaenia with normal monocyte counts. The absence of family history suggests a sporadic condition, and the random distribution of swelling
  • Pet Ownership and Multiple Sclerosis during COVID-19

    Edwards, Laura (2021)
    Background: Multiple sclerosis (MS) is associated with lower quality of life, reduced social participation, and decreased self-efficacy. The COVID-19 pandemic has had documented effects on the health and wellbeing of people with and without MS. Previous research has demonstrated the positive impact pets can have for people living with long-term conditions. Objectives: To explore the rates of pet ownership and pet attachment in people living with MS and pet ownership associations with quality of life, satisfaction with social roles, and self-efficacy scores; and to explore the effects of the COVID-19 outbreak on people's perceived relationships with their pets. Materials and Methods: A postal questionnaire was distributed to members of a local MS Register and a control group of people without MS. The questionnaire assessed quality of life, satisfaction with social roles, self-efficacy, the perceived roles of pets, and pet-related concerns experienced during the COVID-19 pandemic. Results: No apparent difference in attachment to pets was found between the patient and control groups. Pet ownership and level of attachment were not associated with differences in quality of life or self-efficacy scores in people living with MS. Using multiple regression analysis, pet ownership was associated with a decrease in satisfaction with participation in social roles, but with the estimated effect being small compared to having a diagnosis of MS or being unemployed. Most participants reported that pets had positive roles during the pandemic, and the most reported pet-related concern was access to veterinary treatment. Conclusion: Pet owners both with and without MS reported subjective benefits to their wellbeing from pet ownership during COVID-19, although analysis suggested that pet ownership was associated with a reduction in satisfaction with social roles. The study had several limitations and suggestions are made for future work.
  • Myositis, Osteomyelitis and a Parasymphyseal Stress Fracture in a Paediatric Patient

    Hind, Jamie; Ashwood, Neil (Cureus, 2021)
    Abstract The limping child and painful hip are common presentations in many paediatric emergency units. Typically caused by mild self-limiting events, less commonly, they may be implicated in one of a group of inflammatory myopathies, or myositis. Diagnosis of this condition can be extremely difficult, and is aided by thorough clinical assessment, radiological imaging, and extensive blood serum testing. Myositis with associated osteomyelitis and a pathological fracture is an incredibly rare finding, described in this case report in a seven-year-old child.
  • Limb length inequality (LLI) is a frequent and recurring issue after total hip arthroplasty (THA). It is often a source of patient dissatisfaction and litigation. This study reviewed the incidence of LLI in a UK District General Hospital in light of published evidence and identified the preoperative and intraoperative risk factors for LLI.

    Abouelela, Amr; Mubark, Islam; Mohamed, Nagy; Jayakumar, Nithish; Ashwood, Neil; Bindi, Frank (2021)
    Abstract: Methods This was a retrospective study involving 380 consecutive unilateral primary total hip replacements over a period of 12 months. Patient demographics, clinical, radiological, and operative details were collected from the National Joint Registry (NJR) database and hospital records. The limb length was measured radiologically [OrthoView WorkstationTM (Materialise UK, Southampton, UK)], pre- and postoperatively, by two authors. They assessed the vertical distance between the intra-acetabular teardrop line and the medial apex of the lesser trochanters. After excluding complex primary, revision cases, tilted X-rays, and hip replacement for trauma patients, 338 cases were included in the final analysis. ResultsThe mean postoperative LLI was 2.7 mm with a standard deviation (SD) of 6.56 mm. Only 5.3% of patients had LLI >15 mm. None of the studied variables showed a statistically significant correlation with LLI. Even with the apparent difference in the mean LLI between templating and not templating before surgery (2.19 vs. 3.53), the p-value was 0.06, which was below the level of statistical significance. There was a weakly positive Pearson correlation between body mass index (BMI) and the incidence of lengthening of the limb. Conclusion The cause of LLI after THA is multifactorial. No single factor can be singled out as the most significant contributor to this complication.
  • Green Tea Extract Concurrent with an Oral Nutritional Supplement Acutely Enhances Muscle Microvascular Blood Flow without Altering Leg Glucose Uptake in Healthy Older Adults.

    Lund, Jonathan; Williams, John P (2021)
    Postprandial macro- and microvascular blood flow and metabolic dysfunction manifest with advancing age, so vascular transmuting interventions are desirable. In this randomised, single-blind, placebo-controlled, crossover trial, we investigated the impact of the acute administration of green tea extract (GTE; containing ~500 mg epigallocatechin-3-gallate) versus placebo (CON), alongside an oral nutritional supplement (ONS), on muscle macro- and microvascular, cerebral macrovascular (via ultrasound) and leg glucose/insulin metabolic responses (via arterialised/venous blood samples) in twelve healthy older adults (42% male, 74 ± 1 y). GTE increased m. vastus lateralis microvascular blood volume (MBV) at 180 and 240 min after ONS (baseline: 1.0 vs. 180 min: 1.11 ± 0.02 vs. 240 min: 1.08 ± 0.04, both p < 0.005), with MBV significantly higher than CON at 180 min (p < 0.05). Neither the ONS nor the GTE impacted m. tibialis anterior perfusion (p > 0.05). Leg blood flow and vascular conductance increased, and vascular resistance decreased similarly in both conditions (p < 0.05). Small non-significant increases in brachial artery flow-mediated dilation were observed in the GTE only and middle cerebral artery blood flow did not change in response to GTE or CON (p > 0.05). Glucose uptake increased with the GTE only (0 min: 0.03 ± 0.01 vs. 35 min: 0.11 ± 0.02 mmol/min/leg, p = 0.007); however, glucose area under the curve and insulin kinetics were similar between conditions (p > 0.05). Acute GTE supplementation enhances MBV beyond the effects of an oral mixed meal, but this improved perfusion does not translate to increased leg muscle glucose uptake in healthy older adults.
  • Special Low Protein Foods Prescribed in England for PKU Patients: An Analysis of Prescribing Patterns and Cost.

    Mackenzie, A (2021)
    Patients with phenylketonuria (PKU) are reliant on special low protein foods (SLPFs) as part of their dietary treatment. In England, several issues regarding the accessibility of SLPFs through the national prescribing system have been highlighted. Therefore, prescribing patterns and expenditure on all SLPFs available on prescription in England (n = 142) were examined. Their costs in comparison to regular protein-containing (n = 182) and 'free-from' products (n = 135) were also analysed. Similar foods were grouped into subgroups (n = 40). The number of units and costs of SLPFs prescribed in total and per subgroup from January to December 2020 were calculated using National Health Service (NHS) Business Service Authority (NHSBSA) ePACT2 (electronic Prescribing Analysis and Cost Tool) for England. Monthly patient SLPF units prescribed were calculated using patient numbers with PKU and non-PKU inherited metabolic disorders (IMD) consuming SLPFs. This was compared to the National Society for PKU (NSPKU) prescribing guidance. Ninety-eight percent of SLPF subgroups (n = 39/40) were more expensive than regular and 'free-from' food subgroups. However, costs to prescribe SLPFs are significantly less than theoretical calculations. From January to December 2020, 208,932 units of SLPFs were prescribed (excluding milk replacers), costing the NHS £2,151,973 (including milk replacers). This equates to £962 per patient annually, and prescribed amounts are well below the upper limits suggested by the NSPKU, indicating under prescribing of SLPFs. It is recommended that a simpler and improved system should be implemented. Ideally, specialist metabolic dietitians should have responsibility for prescribing SLPFs. This would ensure that patients with PKU have the necessary access to their essential dietary treatment, which, in turn, should help promote dietary adherence and improve metabolic control.
  • Two-Stage Primary Arthroplasty in the Infected Native Knee: A Systematic Review and Pooled Analysis.

    Mishra, Arya; Singh, Harvinder; Cockshott, S; Tambe, Amol (2021)
    INTRODUCTION: The knee is the commonest native joint to develop an infection. A two-stage primary knee replacement, with an interim stage of debridement and cement spacer application, modelled after two-stage revision for periprosthetic joint infections (PJI) has been reported for the management of chronic infections. AIMS: To systematically review the literature to find the infection-free survival and outcomes of this operation and explore its indications. METHODS: PRISMA guidelines were followed for this review. A systematic search of 4 online databases was conducted on 9/8/2020. After reviewing 226 abstracts and applying our selection criteria, 10 papers were selected for full-text review, and 9 included in the final synthesis. RESULTS: On pooled analysis, an infection-free survival of 95.6% (CI 94.7-96.4) was found at 2 years in 139 knees, which was unchanged over the remainder of the follow-up (Mean 3.9 years). The complication rate after final implantation was 6% in those that did not develop reinfection. The mean pooled Knee Society Score (KSS) and KSS Function score among 70 patients (4 papers) was 83.4 (80.1-89.0) and 76.8 (71.5-78.0), respectively. The mean range of motion among 82 patients (6 papers) was more than 100°. CONCLUSIONS: Two-stage primary knee replacement is a safe, effective and reliable procedure with good results in the short to medium term. Further studies are required to lay down precise indications and cost-effectiveness of this procedure, in comparison to other strategies for chronic infection. All joint registries should develop methods to identify patients undergoing two-stage procedures, to understand their long-term survival and outcomes.
  • Paediatric rhombencephalitis presenting with bradycardia: a good recovery despite cardiac involvement.

    Stokes, V; Surridge, Jason (BMJ, 2021)
    Rhombencephalitis is a rare condition, often caused by infection, commonly presenting with myoclonic jerks, ataxia and cranial nerve palsy. Typically, it has a high morbidity and mortality, with worse prognosis associated with cardiopulmonary involvement. Herein, we present the case of a 10-year-old boy, presenting with headache, vomiting, symptomatic bradycardia and rapidly progressing ophthalmoplegia from a sixth nerve palsy, without additional brainstem symptoms. Previously, pericarditis, myocarditis and heart failure have been associated with rhombencephalitis, but not bradycardia. The cause of his rhombencephalitis was presumed viral, but despite extensive screening, the virus responsible was never isolated. Following treatment with intravenous antibiotics and antivirals in a high dependency unit, he recovered well with no neurological deficit on discharge and marked radiological improvement on MRI 4 weeks later. Although rare, rhombencephalitis should be considered in a child presenting with neurological symptoms, particularly alongside a cranial nerve palsy, developing over a rapid time course.
  • SARS-CoV-2 infection is associated with an increased risk of idiopathic acute pancreatitis but not pancreatic exocrine insufficiency or diabetes: long-term results of the COVIDPAN study.

    Awan, Altaf (BMJ, 2021)
    SARS-CoV-2 infection is associated with an increased risk of idiopathic acute pancreatitis but not pancreatic exocrine insufficiency or diabetes: long-term results of the COVIDPAN study.
  • Biomarkers During Recovery From AKI and Prediction of Long-term Reductions in Estimated GFR.

    Packington, Rebecca; Shaw, Susan; Akani, A; Selby, Nicholas (2021)
    RATIONALE & OBJECTIVE: The effects of acute kidney injury (AKI) on long-term kidney function, cardiovascular disease, and mortality are well documented. We aimed to identify biomarkers for estimating the risk of new or worsening chronic kidney disease (CKD) following AKI. STUDY DESIGN: Prospective cohort study. SETTING & PARTICIPANTS: Adults from a single clinical center who developed AKI between May 2013 and May 2016, and survived until 3 years after the hospitalization during which AKI occurred. Participants included those with and without pre-existing CKD. PREDICTORS: Panel of 11 plasma biomarkers measured 3-months after hospitalisation. OUTCOME: Kidney disease progression, defined as a ≥25% decline in eGFR combined with a decline in CKD stage, assessed three years after the occurrence of AKI. ANALYTICAL APPROACH: Associations between biomarkers and kidney disease progression were evaluated in multivariable logistic regression models. Importance of predictor variables was assessed by constructing multiple decision trees, with penalised Lasso logistic regression for variable selection used to produce multivariable models. RESULTS: A total of 500 patients were studied. Soluble tumour necrosis factor receptor 1 (sTNFR1), sTNFR2, cystatin C, neutrophil gelatinase-associated lipocalin (NGAL), three-month eGFR and urine albumin:creatinine ratio (ACR) were independently associated with kidney disease progression and were more important than AKI severity or duration. A multivariable model containing sTNFR1, sTNFR2, cystatin C and eGFR discriminated between those with and without kidney disease progression (AUC 0.79, 95% CI 0.7-0.83). Optimising the cut-point to maximise utility as a 'rule-out' test to identify those at low risk increased the sensitivity of the model to 95% and its negative predictive value to 92%. LIMITATIONS: Lack of external validation cohort. Analyses limited to patients surviving for 3 years after AKI. Mixed population of patients with and without baseline CKD. CONCLUSIONS: A panel of plasma biomarkers measured 3-months after discharge from a hospitalization complicated by AKI provides potential opportunity to identify patients who are at very low risk of incident or worsening CKD. Further study is required to determine its clinical utility through independent prospective validation.
  • Postoperative arginine-enriched immune modulating nutrition: Long-term survival results from a randomised clinical trial in patients with oesophagogastric and pancreaticobiliary cancer.

    Iftikhar, Syed (Elsevier, 2021)
    BACKGROUND & AIMS: Immune modulating nutrition (IMN) has been shown to reduce postoperative infectious complications and length of stay in patients with gastrointestinal cancer. Two studies of IMN in patients undergoing surgery for head and neck cancer also suggested that this treatment might improve long-term survival and progression-free survival. In the present study, we analysed follow-up data from our previous randomised controlled trial of IMN, in patients undergoing surgery for oesophagogastric and pancreaticobiliary cancer, in order to evaluate the long-term impact on survival of postoperative IMN versus an isocaloric, isonitrogenous control feed. METHODS: This study included patients undergoing surgery for cancers of the pancreas, oesophagus and stomach, who had been randomised in a double-blind manner to receive postoperative jejunostomy feeding with IMN (Stresson, Nutricia Ltd.) or an isonitrogenous, isocaloric feed (Nutrison High Protein, Nutricia) for 10-15 days. The primary outcome was long-term overall survival. RESULTS: There was complete follow-up for all 108 patients, with 54 patients randomised to each group. There were no statistically significant differences between groups by demographics [(age, p = 0.63), sex (p = 0.49) or site of cancer (p = 0.25)]. 30-day mortality was 11.1% in both groups. Mortality in the intervention group was 13%, 31.5%, 70.4%, 85.2%, 88.9%, and 96.3% at 90 days, and 1, 5, 10, 15 and 20 years respectively. Corresponding mortality in the control group was 14.8%, 35.2%, 68.6%, 79.6%, 85.2% and 98.1% (p > 0.05 for all comparisons). CONCLUSION: Early postoperative feeding with arginine-enriched IMN had no impact on long-term survival in patients undergoing surgery for oesophagogastric and pancreaticobiliary cancer.
  • Dehydroepiandrosterone (DHEA) role in enhancement and maintenance of implantation (DREAM): randomised double-blind placebo-controlled trial-study protocol.

    Jayaprakasan, Kanna (BMJ, 2021)
    INTRODUCTION: Dehydroepiandrosterone (DHEA) is an important precursor of androgen and has been studied and researched extensively for improving the various outcome measures of ovarian stimulation in women with advanced age or poor ovarian response. Androgens also play an important role in the enhancement of endometrial and decidual function by regulating both the transcriptome and secretome of the endometrial stromal cells and have a positive effect on various factors like insulin-like growth factor binding protein 1, homeobox genes (HOXA10, HOXA11), secreted phosphoprotein 1, prolactin which are necessary for implantation. It is well-known that the circulating 'precursor pool' of DHEA declines with age more so in poor ovarian reserve patients and exogenous supplementation may be beneficial in such cases. This double-blinded randomised controlled trial (RCT) aims to test the hypothesis whether transient targeted supplementation of DHEA as an adjuvant to progesterone in frozen embryo transfer (FET) cycles, for women with low serum testosterone, helps in improving live birth rate. METHODS AND ANALYSIS: This study is planned as a double-blinded, placebo-controlled randomised trial and the sample size, calculated for the primary outcome measure-live birth rate, is 140. All participants will be having a flexible antagonist protocol for controlled ovarian stimulation and an elective freeze-all policy for the embryos as per the hospital protocol after written informed consent. For FET, the endometrium will be prepared by hormone replacement treatment protocol. During the FET cycle, the intervention group will be receiving DHEA 25 mg two times a day for 15 days from the day of starting progesterone supplementation and the control group will be receiving a placebo. ETHICS AND DISSEMINATION: The approval of the study was granted by the Clinical Trials Registry-India and the Institutional Ethical Committee of CRAFT Hospital and Research Center. All participants will provide written informed consent before being randomised into allocated treatment groups. The results will be disseminated to doctors and patients through conference presentations, peer-reviewed publications, social media and patient information booklets. TRIAL REGISTRATION NUMBERS: CTRI/2020/06/025918; ECR/1044/Inst/KL/2018.

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