BACKGROUND: COVID-19 has caused havoc across the globe since, no specific treatment exists for this disease, thus, far. Hence, there is an urgent need to find an effective treatment to mitigate this scourge. Honey and Nigella sativa are two natural substances with anti-inflammatory, anti-viral, anti-microbial and immune modulating properties. They could be potentially beneficial in these patients. METHODS: We conducted an add-on, randomized, open label, placebo-controlled clinical trial using parallel group design. This was a multi-centered study with superiority framework conducted in RT-PCR confirmed COVID-19 patients showing moderate or severe disease. All patients receiving standard care were randomized into treatment and control groups. In the treatment arm, patients received HNS (honey plus Nigella sativa) in predefined doses for up to 13 days. The primary outcome measures (time taken for alleviation of symptoms, viral clearance and clinical status improvement on day 6) outcomes were assessed. RESULTS: Of 1046 patients testing positive for the SARS-CoV-2, 210 showing moderate and 103 showing severe disease were randomized into treatment and control groups as per inclusion criteria. In the moderate cases, 107 were assigned to the HNS group and 103 to the control group. Among 103 severe cases, 50 were assigned to the HNS group and 53 to the control group. In the moderate and severe cases, the HNS treatment was associated with a normalized median symptoms alleviation time reduction of 3 and 7 days (HR: 6.11; 95% CI: 4.23-8.84 and HR: 4.04; 95% CI, 2.46-6.64) respectively. The HNS treatment in both groups were further associated with 4 days earlier reduction in median viral clearance time (Moderate HR: 5.53; 95% CI: 3.76-8.14) and Severe HR: 4.32; 95% CI: 2.62-7.13). Moreover, in the intention-to-treat analysis, the HNS groups led to a lower (better) clinical score on day 6 with resumption of normal activity among 63.6% of the moderate (OR: 0.07; 95% CI: 0.03-0.13) and 28% of severe cases (OR: 0.03; 95% CI: 0.01-0.09). Furthermore, a significant (14.87%) reduction (OR: 0.18; 95% CI: 0.02-0.92) in mortality was observed in the HNS arm. No difference in adverse effects were seen between the HNS and control arms. CONCLUSIONS: A significant reduction in in the severity of disease, the time taken for viral clearance and mortality was observed with HNS treatment in COVID-19 patients. HNS represents a safe, effective, over the counter and affordable therapy for this pandemic essentially lowering health care burden. It can be used alone or in combination with other expensive treatments and give an additive effect. Hence, the potential of HNS against COVID-19 should be explored in future larger studies. (Funded by Smile Welfare Organization, Shaikh Zayed Medical Complex and Services Institute of Medical Sciences; NIH Clinical Trial Register number: NCT04347382.)
Objectives Considering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS. Trial design The study is a randomized, placebo-controlled, adaptive clinical trial with parallel group design, superiority framework with an allocation ratio of 1:1 among experimental (HNS) and placebo group. An interim analysis will be done when half of the patients have been recruited to evaluate the need to adapt sample size, efficacy, and futility of the trial. Participants All asymptomatic patients with hospital or community based COVID-19 exposure will be screened if they have had 4 days exposure to a confirmed case. Non-pregnant adults with significant exposure level will be enrolled in the study High-risk exposure (<6 feet distance for >10min without face protection) Moderate exposure (<6 feet distance for >10min with face protection) Subjects with acute or chronic infection, COVID-19 vaccinated, and allergy to HNS will be excluded from the study. Recruitment will be done at Shaikh Zayed Post-Graduate Medical Institute, Ali Clinic and Doctors Lounge in Lahore (Pakistan). Intervention and comparator In this clinical study, patients will receive either raw natural honey (0.5 g) and encapsulated organic Nigella sativa seeds (40 mg) per kg body weight per day or empty capsule with and 30 ml of 5% dextrose water as a placebo for 14 days. Both the natural products will be certified for standardization by Government College University (Botany department). Furthermore, each patient will be given standard care therapy according to version 3.0 of the COVID-19 clinical management guidelines by the Ministry of National Health Services of Pakistan. Main outcomes Primary outcome will be Incidence of COVID-19 cases within 14 days of randomisation. Secondary endpoints include incidence of COVID-19-related symptoms, hospitalizations, and deaths along with the severity of COVID-19-related symptoms till 14th day of randomization. Randomisation Participants will be randomized into experimental and control groups (1:1 allocation ratio) via the lottery method. There will be stratification based on high risk and moderate risk exposure. Blinding (masking) Quadruple blinding will be ensured for the participants, care providers and outcome accessors. Data analysts will also be blinded to avoid conflict of interest. Site principal investigator will be responsible for ensuring masking. Numbers to be randomised (sample size) 1000 participants will be enrolled in the study with 1:1 allocation. Trial Status The final protocol version 1.4 was approved by institutional review board of Shaikh Zayed Post-Graduate Medical Complex on February 15, 2021. The trial recruitment was started on March 05, 2021, with a trial completion date of February 15, 2022. Trial registration Clinical trial was registered on February 23, 2021, www.clinicaltrials.gov with registration ID NCT04767087. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.
In this case research, an effort was made to analyze the diabetogenic statins effect, as well as the way this is associated with different comorbidities associated. Study Design: Cross-Sectional Study Place of Study: Punjab Institute of Cardiology Lahore. Duration of Study: October 2020 to March 2022 Materials and Methods: This cross-sectional study was conducted at the Department of Cardiology between October 2020 to March 2022 for duration of one year and Five months in order to collect the necessary data. Participants were required to have had normal blood sugar levels when they began taking statins and to have been on statins for at least one year prior to eligibility. Those who had never been diagnosed with diabetes mellitus were more likely to get the condition as a result of this study, according to the findings new Onset Diabetes Mellitus (NODM). Both the glucose and insulin concentrations in the blood were subjected to estimation. The subjects saw and reported additional adverse effects caused by statins and comorbidities associated with them. To meet the objective of analyzing adverse reactions to drugs, descriptive statistics were required. Result: The most commonly prescribed dosage for statins was 40mg of atorvastatin, according to the statistics. Diabetes was detected in roughly 25 percent of patients on 80mg of atorvastatin. Conclusion: The use of statins is related with a risk of non-alcoholic fatty liver disease ranging from low to significant (NODM). The amount of statin medication a person takes is one of the most influential contributors to the increase in diabetes risk linked with statin use. Keywords: Hyperglycemia, newly diagnosed diabetes, statins, and type 2 diabetes
Background: A recognized surrogate marker that can be utilised for the prediction and profiling of atherosclerotic cardiovascular disease is the thickness of the intima-media layer. Despite the fact that it varies geographically and ethnically, the significantly less likely to have it documented. This is despite the fact that there are many different communities . As a result of the process of atherosclerosis, the left anterior descending coronary artery is one of the coronary arteries that is afflicted the most of the time. As a consequence of this, the goal of this study was to determine whether or not there is a correlation between the intima-media thickness of the left coronary artery and the characteristics of the artery based on its morphology. Time and Place of study: Shaikh Zayed Hospital Lahore March 2019 to October 2021 Results: The thickness of the intima and media, on average, was 0.334 + 0.05 mm. It was more prevalent in males than in females.0.329+0.01 mm in females, increased with the number of branches of the left coronary artery, starting from 0.329+0.01 mm in males bifurcation to 0.499+ 0.01 mm in pentafurcation; and was also greater in left coronary arteries that were shorter than the average length of the right coronary artery 0.5mm, in addition to those with bifurcation angles greater than 700. Conclusion: The length, bifurcation angle, and terminal branching pattern of the left coronary artery all have an impact on the intima-media thickness of the left anterior descending artery. Additionally, the intima-media thickness of the left anterior descending artery is greater in males than it is in females. It can be deduced from this that the morphological characteristics of the left coronary artery are anatomical factors that contribute to the development of atherosclerosis.Screening for atherosclerosis ought to be done on those who exhibit these characteristics in order to provide early intervention.
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