Contemporary Clinical Trials Communications

ObjectivesTo investigate how nutrition readiness to change influences implementation of dietary behavior changes and to compare the gut microbiomes and document gut microbiome composition changes over time in individuals with early Alzheimers disease dementia (eAD), mild cognitive impairment (MCI), and healthy controls (HC) Overall, this study aims to add to the emerging field of how the gut microbiome influences the nervous system. MethodsThis is a sub-study of a multi-prong proof-of-concept, observational study mapping the gut microbiome: 15 HC, 15 MCI, 15 eAD (n=45). At 0-, 3-, and 6-months, participants are provided lifestyle recommendations tailored to their gut microbiome. Participants may choose to implement this or not and are observed throughout (observational intervention study). In this sub-study, a survey is developed and implemented in conjunction with dietary assessment (DietID) to evaluate the role of Readiness to Change in implementation of dietary recommendations. ResultsThis is the sub-study protocol from an ongoing parent study. DiscussionThis protocol presents a novel intervention to assess the gut microbiome, individual dietary patterns, and readiness to make lifestyle change related to diet. Trial RegistrationNCT06039267

IntroductionChronic atrophic gastritis (CAG) is a precancerous disease that is difficult to treat. Even after eradication of the Helicobacter pylori (HP) infection, complete resolution of the symptoms is difficult to achieve. The fortifying the spleen, clearing heat, activating blood method (FSCHABM) has an excellent curative effect in the treatment of CAG. A real-world study is particularly suitable for researching the treatment of CAG, but there are currently no reports on CAG trials. Our aim is to design a high-quality trial to investigate the efficacy and safety of FSCHABM in treating CAG patients. Methods and analysisThis protocol is designed as a real-world study for 10 years. A total of 5000 participants will be assigned to a FSCHABM treatment group or a non-FSCHABM treatment group at a 1:1 ratio at the first Affiliated Hospital of Guangzhou University of Chinese Medicine. Patients are given 1-2 courses of a 24-week-long treatment. The participants will be followed up for observation and measurement of the following indicators: the primary outcome is the histopathological indicator; the secondary outcome includes evaluation of gastric lesions, syndrome curative effect, evaluation of symptoms, evaluation of quality of life, evaluation of anxiety and depression, economic evaluation and other indicators. This is the first real-world study evaluating the therapeutic effect of FSCHABM in the treatment of CAG in clinical practice. This protocol can provide a reference for future multi-center, randomized, controlled trials. Strengths and limitations of this studyit is the first time to carry out TCM study related to CAG by using the real-world study. A large number of patients and a long-term study can effectively reflect the effect of TCM treatment and reduce the bias. The precise research protocol makes the whole research more accurate and reliable. The limitations of implementing this protocol are expending a lot of time, manpower and economic resources inevitably. Ethics and disseminationthis study was approved by Ethical committee of the first Affiliated Hospital of Guangzhou University of Chinese Medicine. Study findings will be shared with participants, healthcare providers, and policymakers through research reports, conference presentations, and the Internet. The results will also be disseminated through publication in peer reviewed journals. Trial registrationThe registration number, ChiCTR1900027177, was assigned by the Chinese Clinical Trial Registry on 3 November 2019. FundingThis work was supported by Guangdong natural science fund project, China (2019),No.2019A1515011145; Major research project of Guangzhou University of Chinese medicine, China (2019), No.A1-2606-19-110-007; The first affiliated hospital of Guangzhou University of Chinese medicine "innovation foster hospital" clinical research project, China (2019), No.2019IIT19; Guangdong natural science foundation (PhD) project, China (2017), No.2017A030310121; The first affiliated hospital of Guangzhou University of Chinese medicine "innovation foster hospital" innovation research team project, China (2017), No.2017TD05; The first affiliated hospital of Guangzhou University of Chinese medicine "innovation foster hospital" Youth scientific research talent training program, China (2015), No.2015QN09.

BackgroundCoronary heart disease(CHD) is a common disease of the cardiovascular system. Percutaneous coronary intervention(PCI) has been proven an effective treatment. Various complications after PCI may further affect the long-term efficacy of PCI. Previous trials have showed that both kinesitherapy(KT) and acupuncture are beneficial to patients with CHD, but need further confirmation. Acupuncture kinesitherapy(AKT) is a kind of combination therapy of acupuncture with exercise training. In this study, we plan to conduct a randomized controlled trial(RCT) to confirm the superior efficacy of AKT compared to KT and conventional medical therapy(MT) in post-PCI rehabilitation for CHD patients, and to further guide the clinical strategy. MethodsThis is a single-center randomized controlled trial with 3 parallel arms. We will recruit 102 CHD patients after PCI and randomly assign them to 3 groups. Participants in 3 groups will receive 2-week MT. Besides, participants in AKT and KT groups will also receive acupuncture kinesitherapy and kinesitherapy alone, respectively. They will be treated once a day, 5-day a week, and the treatment course will last for a total of 2-week with a 2-day off during the course. The primary outcome is the changes in cardiac function. The secondary outcomes include aerobic capacity, muscle strength, flexibility, balance, coordination, mental status, and activity of daily living. All outcomes will be measured at baseline and 2-week after treatment. Adverse events also will be recorded. The cardiac function and activities of daily living will be followed up at 1, 3 and 6 months after treatment. DiscussionWe expect findings of trial will provide important insight into application of AKT as a safety and more effective method for CHD patients. Successful completion of this proposed study will also contribute to promotion of AKT in the clinic in the future. Trial registrationChinese clinical trial registry (Register Number: ChiCTR2100048960) http://www.chictr.org.cn/index.aspx.

BackgroundThis is the first attempt to assess changes in liver abnormalities before and after contingency management (CM) to reduce heavy drinking beyond 30-days of follow-up. ObjectiveThe main objective was to determine whether liver fibrosis and steatosis, measured using FibroScan, change significantly between baseline, 30-days, and 90-days among older adults who drink heavily at baseline, enrolled in the CM intervention for alcohol reduction. The secondary aim of the study was to assess whether the changes in liver outcome measures differ across alcohol consumption categories. MethodsA prospective study (ClinicalTrials.gov registry: NCT03353701) of 46 older adults (63% male, 76.1% Black, mean age = 56.4) with heavy drinking at the baseline, living with or without HIV infection was evaluated. A linear mixed-effects model was used to analyze the FibroScan Transient Elastography (TE for fibrosis) and Controlled Attenuation Parameter (CAP for steatosis). ResultsThere were no significant changes in liver fibrosis and steatosis measures after 90-days of drinking abstinence among heavy drinkers with or without stratified TE or CAP values at baseline. ConclusionsCM for drinking reduction may not be effective at least short-term prospective in preventing liver fibrosis and steatosis progression for subjects without severe liver disease at baseline.

BackgroundAdequate bowel preparation is one of the most important prerequisite during the colonoscopy. It is conductive to detect the polypus, adenoma and early colorectal carcinoma and decrease the rate of overuse of medical resource. BianShi Moxibustion(BSM) is one of the most important Traditional Chinese Medicine(TCM) treatment options, which is called TCM proper technology. BSM is applied to prevent and cure digestive system disorder widely, including functional constipation(FC), irritable bowel syndrome(IBS), functional dyspepsia(FD) etc. we speculate that BSM can improve the bowel preparation quality through ameliorating the function of digestive tract, especially in high risk of inadequate bowel preparation patients, including elderly individual, diabetes mellitus, neurodegenerative changes etc. Hence, the objective of this research is to evaluate the efficacy of BSM on the quality of bowel preparation before colonoscopy. MethodThis is a randomized triple-blinded, single-center, prospective study. We will recruit 72 inpatients who are scheduled to undergo colonoscopy for screening and diagnostic or therapeutical purposes for the first time will be randomized to assign into treatment group or control group at a ratio of 1:1. The intervention plan in the treatment group consists of 3L polyethylene glycol(PEG) solution plus BSM(Treatment period is 3 days, Qd). In the control group, the plan is 3L PEG plus sham BSM. Boston Bowel Preparation Scale(BBPS) will be used to evaluate the efficacy of the bowel preparation and regarded as the primary outcome measure. The secondary outcomes including caecal intubation rate, the willingness to repeat colonoscopy, the tolerance of bowel preparation regimens, the rate of adverse events. DiscussionThe aim of this clinical trial is to confirm the influence of BSM on the quality of bowel preparation. The hypothesis of this study is that the BSM has a positive role on the quality of bowel preparation. The routine bowel preparation regime combines with TCM proper technology will enhance bowel preparation quality and ameliorate the subjective feeling of participants. In addition, it will provide the reliable evidence of bowel preparation prior to colonoscopy from the point of view of integrative medicine. Trial registrationThis protocol and trial was registered in the Chinese Clinical Trial Registry(ChiCTR2300077168).

Exercise can boost physical and cognitive health in older adults. However, there are a lack of accessible exercise programs that foster adherence among older adults. In this study, we aimed to establish the safety and feasibility of APEX, a new exercise program designed to optimize fitness and cognitive gains for older adults, in addition to evaluating its acute physiological effects, and assessing its possible effects on functional fitness and cognition among healthy older adults. APEX utilizes a multimodal progressive high-intensity interval training (HIIT) design, with high-intensity intervals focused on enhancing cardiovascular fitness and muscle strength, and recovery intervals that incorporate balance and mobility exercises. The APEX training was tested in healthy older adults (n=4) over the course of four weeks. Ultimately, APEX was found to be safe and feasible, with no adverse events and high adherence. Participants met heart rate targets for all of the high-intensity exercises, and all intervals had a significant difference in heart rates between high-intensity and recovery periods in linear effects models (p<0.001). Improvements in functional fitness were observed in aerobic endurance, lower body strength, and balance. The intervention was also associated with positive trends in the cognitive domains of information processing, working memory, executive control, and attention. APEX offers a promising alternative to traditional cardiovascular exercise modalities for older adults with additional benefits for functional fitness and cognition. These results encourage further testing of the APEX program in older adults and different clinical populations.

Gastrointestinal disorders, especially stomach problems, are widespread. This prospective, non-interventional, comparative study investigated safety and efficacy of an herbal medical device for the treatment of stomach disorders. For the first 14 days, the patients did not take the test product and started the intake on day 15 for a duration of 14 days. Full data sets of 100 included patients were assessed. Symptoms were assessed by a visual scale weekly (day 1 to day 28) and changes of the overall recognised symptoms on a 3-stage scale in phase II (day 15 to day 21). Over the whole study duration, the patients documented the daily overall symptom severity in a patients diary and all adverse events were assessed. During phase I, most of the symptoms remained unchanged. After phase II, the overall mean severity of gastrointestinal disorders as well as the specific symptom severity had improved significantly. The course of symptom severity was significantly different between both phases, in favour of the study product. Additionally, an average of 56% of patients reported a subjectively reduced symptom severity after day 28. The study product has shown a good efficacy and safety profile in the treatment of gastrointestinal disorders.

BackgroundAYUSH 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 - 19 MethodologySingle 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.

Background and aimsMaintenance of abstinence in alcohol-related liver disease (ARLD) is a major unmet therapeutic need. Digital therapeutics can deliver ongoing behavioural therapy, in real-time, for chronic conditions. The aim of this project was to develop and clinically test AlcoChange, a novel digital therapeutic for ARLD. MethodsAlcoChange was developed using validated behaviour change techniques (BCTs) and a digital alcohol breathalyser. This was an open-label, single-centre study. Patients with ARLD, ongoing alcohol use (within 1 month) and possession of a suitable smartphone were eligible. Patients were recruited from inpatient and outpatient settings, and received AlcoChange therapy for 3-months. The primary outcome was reduction in alcohol use from baseline to 3-months, measured by timeline follow-back (TLFB). Secondary outcomes included: (i) compliance with the AlcoChange app, (ii) alcohol-related and all-cause hospital re-admissions up to 1-year, (iii) qualitative analysis to determine factors associated with compliance. ResultsSixty-five patients were recruited, of whom forty-one completed the study per-protocol. Patients compliant with the intervention (>60 logins over 3-months) had a significant reduction in alcohol use from baseline compared to non-compliant patients [median (IQR): -100% (100% to -55.1%) vs -57.1% (-95.3% to +32.13%), p=0.029]. The proportion attaining abstinence at 3-months was higher in the compliant group (57.1% vs 22.2%, p=0.025). The compliant group had a significantly decreased risk of subsequent alcohol-related re-admission up to 12-months (p=0.008). Qualitative analysis demonstrated receiving in-app feedback and presence of health-related sentinel event were predictors of compliance with the intervention. ConclusionsUse of the novel digital therapeutic, AlcoChange, was associated with a significant reduction in alcohol use and increase in proportion attaining abstinence in ARLD patients. Definitive, randomized trials are warranted for this intervention.

Cancer-related fatigue (CRF) is a common and burdensome, often long term side effect of cancer and its treatment. Many non-pharmacological treatments have been investigated as possible CRF therapies, including exercise, nutrition, health/psycho-education, and mind-body therapies. However, studies directly comparing the efficacy of these treatments are lacking. To fill this gap, we conducted a parallel single blind randomized control trial with women with CRF to directly compare the effects of Qigong (a form of mind-body intervention) (n=11) to an intervention that combined strength and aerobic exercise, plant-based nutrition and health/psycho-education (n=13). This design was chosen to determine the comparative efficacy of two non-pharmacologic interventions, with different physical demand intensity, in reducing the primary outcome measure of self-reported fatigue (FACIT Additional Concerns subscale). Both interventions showed a mean fatigue improvement of more than double the pre-established minimal clinically important difference of three (Qigong: 7.068 +/- 10.30, Exercise/Nutrition: 8.846 +/- 12.001). Mixed effects ANOVA analysis of group x time interactions revealed a significant main effect of time, such that both groups significantly improved fatigue from pre- to post treatment (F(1,22)=11.898, p=.002, generalized eta squared effect size=.116) There was no significant difference between fatigue improvement between groups (independent samples t-test: p=.70), suggesting a potential equivalence or non-inferiority of interventions, which we could not definitively establish due to our small sample size. This study provides evidence from a small sample that Qigong improves fatigue similarly to standard exercise-nutrition. Qigong additionally significantly improved secondary measures of mood, emotion regulation, and stress, while exercise/nutrition significantly improved secondary measures of sleep/fatigue. These findings provide preliminary evidence for divergent mechanisms of fatigue improvement across interventions, with Qigong providing a gentler and lower-intensity alternative to exercise/nutrition. This clinical trial was registered with clinicaltrials.gov.

IntroductionPeptic ulcer (PU) is prone to recurrence and can have a prolonged course, significantly impacting patients quality of life. Clinical treatment commonly involves combating Helicobacter pylori(HP), reducing gastric acid secretion, and promoting gastric mucosal protection. Nevertheless, Western medicine often entails various adverse effects and long-term use. Consequently, numerous scholars have redirected their focus towards traditional Chinese medicine (TCM) for external treatments of PU due to its minimal toxicity, fewer side effects, and lower recurrence rates. This study aims to assess the efficacy and safety of Acupoint herbal patching (AHP) in treating PU, offering a foundation for future clinical investigations. Methods and analysisThe computer will conduct a comprehensive search for relevant studies on the utilization of AHP in the management of PU from the inception of the database in various scholarly platforms including China Journal Network, Wanfang Database, Chongqing Wipo Database, China Biomedical Literature Database, PubMed, and Cochrane Library. Eligible literature will undergo meticulous scrutiny based on predefined criteria, with data extraction and quality assessment executed independently by two researchers. Meta-analysis utilizing RevMan 5.4.1 software will be employed to synthesize the collected data. The study will focus on the TCM Symptom Score Scale as the primary outcome measure, while secondary outcomes will encompass serum inflammatory factors, endoscopic findings, quality of life, recurrence rate, and adverse events. Furthermore, assessments on effectiveness, cure rate, and potential publication bias will be carried out. This investigation aims to assess the efficacy of AHP in the treatment of PU and its impact on enhancing the well-being of patients. Ethics and disseminationSince the present work constitutes a literature review, it is important to note that ethical approval is deemed unnecessary. The outcomes of this investigation are intended for dissemination in a scholarly periodical subject to peer review. PROSPERO registration numberCRD42023456995 STRENGTHS AND LIMITATIONS OF THIS STUDYA thorough examination of the literature will be undertaken across six electronic databases in both Chinese and English languages. The methodology will adhere to the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Evaluation of the studies quality will be conducted utilizing the updated Cochrane Risk of Bias 2.0 tool. Variations in patch locations and treatment protocols may introduce significant heterogeneity, posing challenges to the synthesis of data.

ObjectivePhysiotherapists are supposed to have a great impact on the body awareness of their clients through passive and active measures. The aim of this study was to investigate the effect of a single session of manual massage or exercise on body awareness. MethodsA three-arm randomized controlled study including 96 healthy volunteers (18 - 65 years) was conducted at the Institute of Physical Medicine & Rehabilitation, at the Kepler University Hospital in Linz/Austria. Anonymous questionnaire assessments and analysis with intention-to-treat approach were performed. Participants were assigned to a single intervention of massage (full-body massage with slow strokes and gentle kneading), exercise (moderate body workout, video-based exercise instructions) or lecture on medicinal herbs (video-based lecture, control group). Primary endpoints were the changes of body awareness recorded with the non-verbal Awareness Body Chart test. Secondary endpoints were the changes of body awareness scored with a German body awareness questionnaire (Kurzer Fragebogen zur Eigenwahrnehmung des Koerpers, KEKS) and changes in mood scored with a German questionnaire on mood (Befindlichkeitsfragebogen). ResultsThe Awareness Body Chart total score increased in both intervention groups but not in the control group with significant differences in the change between control group and both other groups (massage vs. control: +0.47, 95% CI 0.30 to 0.64; exercise vs. control: +0.31, 95% CI 0.15 to 0.45; massage vs. exercise: +0.19, 95% CI -0.02 to 0.34). An increase of the KEKS total score was found in the exercise in comparison to the control group. Mood significantly improved in both intervention groups compared to the control group. ConclusionsIn this study single session interventions of massage or exercise presented immediate positive impact on body awareness and furthermore on mood. The trial may serve as a prototype for further research on body awareness. Trial RegistrationRegistered in the clinicaltrials.gov database (NCT05004272)

BackgroundIrregular bowel habits including constipation are common gastrointestinal issues, significantly impacting quality of life. While conventional pharmacological treatments exist, they often come with side effects and offer limited long-term relief, driving interest towards safer, effective herbal alternatives. Cassia fistula (C. fistula) has long been recognized for its laxative properties and has been reported to be a safer alternative to Senna (Cassia angustifolia). PurposeThis study aimed to evaluate the efficacy and safety of a standardized extract of C. fistula compared to Senna extract in healthy individuals experiencing irregular bowel habits. MethodsA two-arm, open-label, randomized, multicentric, interventional, prospective clinical study was conducted in India with 70 participants (35 per group). One group received the standardized C. fistula extract and the other group received Senna extract for 14 days, followed by a 7-day post-consumption follow-up. Primary outcomes included changes in bowel movement frequency. Secondary outcomes assessed stool consistency (Bristol Stool Form Scale), straining, bowel satisfaction after defecation, anorectal blockage, use of manual manoeuvres, average time spent on defecation, time to first bowel evacuation post intervention and associated clinical symptoms (headache, belching, flatulence, abdominal distension, acidity). Safety was evaluated through vitals, laboratory parameters, and adverse events. ResultsC. fistula extract significantly increased bowel movement frequency (3.30 {+/-} 0.92 to 5.90 {+/-} 1.24 at Day 14, p<0.05) and improved stool consistency comparable to Senna extract. Straining and bowel satisfaction after defecation also significantly improved with the use of C. Fistula. Notably, C. fistula extract showed significantly greater reduction in the sensation of anorectal blockage at Days 14 and 21 (p<0.05) and a faster onset of action (shorter time to first defecation) compared to Senna. Associated symptoms of constipation also reduced significantly. C. fistula extract was better well-tolerated, with fewer product-related adverse events compared to Senna. ConclusionC. fistula extract was found to be effective in irregular bowel habits, offering comparable efficacy to Senna while proving to be superior in reducing the sensation of anorectal blockage and achieving a faster time to first bowel evacuation. It also demonstrated a more favorable safety profile with significantly fewer product-related adverse events. Therefore, C. fistula extract represents a promising non-habit-forming herbal alternative for bowel regulation.

ObjectivesThis study explored the feasibility and preliminary efficacy of a music-based, multicomponent exercise intervention among community-dwelling older adults with mild-to-moderate cognitive impairment. Methods13 older adults aged 85{+/-}9 years with mild-to-moderate cognitive impairment completed multicomponent exercise training for 20 weeks at an independent living facility. Participants received aerobic, resistance, and balance training paired with beat-accentuated music stimulation (BMS). Participants adherence to the training was tracked down and their cognitive and physical functioning and quality of life were assessed at pre- and post-test. Results13 participants attended an average of 4.6 days/week over 20 weeks and reported high satisfaction with the intervention (90.6%). Participants showed significant improvement in global cognition, cognitive processing speed, and walking endurance/aerobic fitness at post-test. ConclusionsThese findings support the feasibility of music-based, multicomponent exercise training for older adults in an independent living facility and set the stage for future studies to test the efficacy of music on physical activity and ensuing health outcomes. Clinical ImplicationsMusic-based, multicomponent exercise training can be beneficial for community-dwelling older adults with mild-to-moderate cognitive decline. BMS can be combined with exercise training to manipulate exercise tempo and may provide a source of motivation to help older adults adhere to exercise.

Iodine has strong antimicrobial properties and has been used in topical applications as antiseptic. Its systemic use in form of iodine complexes derived from dried seaweed extract is beneficial in treating various disorders. Hepatitis C Virus (HCV) chronic infection is present in 6-10% of the Pakistani population and is a major healthcare burden that could benefit from innovative therapeutic regimens. ObjectiveA pilot study has shown the safety and efficacy of iodine complexes in chronic Hepatitis C virus infection. and this clinical study is aimed to further explore the previous findings. MethodsThis is an open-labeled, active-controlled, three-arm, parallel-group study including 90 patients of chronic HCV infection with each arm having 30 patients. The patient groups received 15mg/day iodine complex only, the standard of care therapy interferon+ribavirin, and iodine complex in combination with interferon+ribavirin regimen for 6 months. Efficacy assessment will base upon post-treatment Rapid Virological Response (RVR) at 4 weeks, Early Virological Response (EVR) at 12 weeks, and End of Treatment Viral Response (ETR) at 24/48 weeks. ResultsAs only 3.33% of patients showed at the ETR with iodine complex alone, combination with interferon+ribavirin showed significant improvement in comparison to interferon+ribavirin alone. Iodine complex+ interferon+ribavirin showed 80% RVR and 90% ETR while the standard of care therapy showed 66.7% RVR and 76.67% ETR, respectively. No additional adverse events of iodine complex were observed. ConclusionIodine complex showed a significant synergistic effect when combined interferon+ribavirin regimen and could be useful in relapsers and non-responders.

The authors have withdrawn this manuscript because they found a serious issue in data-analysis which leads to wrong interpretation of the results. Therefore, the authors do not wish this work to be cited as reference for the project. If you have any questions, please contact the corresponding author.

BackgroundHigh-intensity interval or circuit-based strength training utilizes brief intense periods of strengthening exercises interspersed with rest/light activity or performed in a continuous circuit. The physical and cognitive effects of this time-efficient approach in community-dwelling older adults have not been systematically reviewed. ObjectivesTo determine the effects of high-intensity interval or circuit-based strength training interventions on physical and cognitive functioning for community-dwelling older adults, and the associated adherence, retention, and adverse event rates. MethodsSix databases will be searched from inception to November 2021; MEDLINE, EMBASE, CINAHL, AgeLine, SPORTDiscus, and Web of Science. To assess physical and/or cognitive functioning effects, randomized and quasi-randomized controlled trials (RCTs and Q-RCTs) of high-intensity interval or circuit-based strengthening interventions in community-dwelling older adults, utilizing any comparator, will be included. The above criteria will be extended to include non-randomized study designs to assess adherence, retention, and adverse events. All screening, data extraction and risk of bias will be assessed by two independent reviewers. Risk of bias will be assessed utilizing the Cochrane RoB 2 tool for randomized and ROBINS-I for non-randomized studies. Qualitative synthesis will be used to present information on adherence, retention, and adverse event rates. Qualitative and/or quantitative synthesis will be used to present physical and cognitive functioning effects depending on which method is deemed appropriate for the various outcomes. ConclusionThis systematic review will be the first to summarize the physical and/or cognitive effects, adherence, retention, and adverse events reported in high-intensity interval and circuit-based strengthening interventions for community-dwelling older adults. Systematic review registration numberCRD42021284010

IntroductionThe main objective of the study will be to evaluate the effects of two widely used standardized mindfulness-based programs [Mindfulness-Based Stress Reduction (MBSR) and Compassion Cultivation Training (CCT)], on epigenetic, neurobiological, psychological, and physiological variables. MethodsThe programs will be offered in an intensive retreat format in a general population sample of healthy volunteer adults. During a 7-day retreat, participants will receive MBSR and CCT in a crossover design where participants complete both programs in random order. After finishing their first 3-day training with one of the two programs, participants will be assigned to the second 3-day training with the second program. The effects of the MBSR and CCT programs, and their combination, will be measured by epigenetic changes (i.e., DNA methylation biomarkers), neurobiological and psychophysiological measures (i.e., EEG resting state, EKG, respiration patterns, and diurnal cortisol slopes), self-report questionnaires belonging to different psychological domains (i.e., mindfulness, compassion, well-being, distress, and general functioning), and stress tasks (i.e., an Arithmetic Stress Test and the retrieval of negative autobiographical memories). These measures will be collected from both groups on the mornings of day 1 (pre-program), day 4 (after finishing the first program and before beginning the second program), and day 7 (post-second program). We will conduct a 3-month follow-up using only the set of self-report measures. DiscussionThis study aims to shed light on the neurobiological and psychological mechanisms linked to meditation and compassion in the general population. The protocol was registered at clinicaltrials.gov (Identifier: NCT05516355; August 23, 2022).

BackgroundMore than 6.2 million people have died already from COVID-19. Drug resistance and relapse cases from first generation therapeutics calls for development of new drugs in alternative medicine. Complementary and Alternative Medicines (CAM) that include herbal remedies and phytochemicals are usually not fully integrated into mainstream healthcare systems. The study proposes a CAM remedy, a new polyherbal formulation NAOQ19 against the SARS-CoV-2. MethodsThe present study consists of invitro and invivo evaluation of NAOQ19 against SARS-CoV-2 infection. First, invitro testing of NAOQ19 anti-viral activity was carried out on three relevant cell lines: Vero E6, A549ACE2 and Huh 7.5.1 ACE2TMPRSS2. Next, animal model testing of NAOQ19 was performed in Syrian golden hamsters along with positive control Remdesivir and infection control for 3 days to determine the efficacy and safety of the formulation. Finally, a double blind randomized clinical trial with mild to moderate COVID-19 infected patients were evaluated to test the efficacy of NAOQ19 in human settings. ResultsThis study demonstrated a strong anti-viral (low EC50) activity in cell culture with live virus and exhibits reduced plaque forming units (high antiviral activity) in the Syrian golden hamster model. Moreover, in the clinical trials, NAOQ19 shows high efficacy demonstrating early recovery and reduced levels of inflammatory biomarkers among COVID-19 infected patients. ConclusionThis novel polyherbal formulation NAOQ19, demonstrates strong anti-viral activity in preclinical and clinical study; thereby proving its candidacy as a low-cost alternative medicine with minimal adverse effects.

Frailty is a state of increased vulnerability resulting from aging due to cumulative decline in physiological system over a lifespan. Few pharmacological agents have been investigated for the treatment of frailty. In Ayurveda, Ashwagandha (Withania Somnifera) is a popular botanical medicine used for improvement in physical strength and mental stress and has a potential for treatment of frailty. This placebo-controlled study assessed the efficacy and safety of a capsule containing 300mg of Ashwagandha Root Extract (ARE) administered twice daily orally for 8 weeks. Fifty elderly subjects with a frailty score [&ge;]7 based on Frailty Assessment and Screening Tool (FAST) were randomized in a 1:1 ratio to receive either Ashwagandha (ARE, n=25) or placebo (PL, n=25). Improvement in frailty after 8 weeks was assessed by FAST, 6-minute Walk Test (6MWT), Pittsburgh Sleep Quality Index (PSQI), Mini-Mental State Examination (MMSE) and Short Form Survey (SF-12) scores. Blood samples were collected at baseline and week 8 for estimation of C-Reactive Protein (CRP), cortisol and Creatinine Kinase (CK). Significant improvement (p<0.01) in scores for FAST, 6MWTs, PSQI, MMSE, and SF-12 were seen with ARE after 8 weeks. Also, significant improvements (p<0.05) were observed in CK and in CRP with ARE. These improvements were greater (p<0.05) with ARE as compared to placebo. ARE was well tolerated with no adverse effects, and no changes in hepatic and renal parameters. Thus, Ashwagandha root extract can be a valuable therapeutic option for improvement of health condition in frailty.