Parallel-group Pilot Study Research Articles

Effect of Perioperative Inhaled Tiotropium for patients with chronic Obstructive Pulmonary disease in Esophageal cancer surgery (EPITOPE): an open-label, randomized, parallel-group pilot study.

Chronic obstructive pulmonary disease (COPD) is a risk factor for pneumonia following esophagectomy. This study aimed to investigate the efficacy of perioperative inhaled tiotropium in patients with COPD undergoing esophagectomy. This open-label, randomized controlled trial randomly assigned 32 patients with COPD undergoing esophagectomy to conventional management or addition of tiotropium inhalation. The intervention group received tiotropium from two weeks before esophagectomy until the final evaluation one month after esophagectomy. The primary outcome was the incidence of pneumonia within 30 postoperative days. We also assessed the changes and the percentages from baseline in pulmonary function and walking distance of the incremental shuttle walking test to just before esophagectomy and final evaluation. Enrolled patients were randomly assigned to the control group (n = 18) and the intervention group (n = 14). Pneumonia was recorded in 4 (28.6%) and 5 (27.8%) patients in the intervention and control groups, respectively (risk difference: 0.8%, 95% confidence interval: - 30.6 to 32.2). The intervention group demonstrated a significant improvement in pulmonary function and walking distance preoperatively. Further, the pulmonary function test was significantly better preoperatively in the intervention group than in the control group. Postoperatively, pulmonary function deterioration was more significant in the control group than in the intervention group. Preoperative tiotropium inhalation significantly improved pulmonary function and exercise tolerance in patients with COPD undergoing esophagectomy. The perioperative tiotropium did not reduce pneumonia after esophagectomy, but it may contribute to patient recovery by reducing postoperative pulmonary function deterioration.

Effects of rhamnose consumption on bone mineral density in healthy postmenopausal women: a randomised, placebo-controlled, double-blind, parallel-group pilot study

Preventing the decrease in bone mineral density (BMD) is significant for postmenopausal women. We previously discovered that rhamnose, a deoxy monosaccharide used as a food additive, could suppress bone resorption; however, studies confirming this effect in postmenopausal women are lacking. Therefore, this pilot study aimed to explore whether rhamnose could help maintain BMD via bone resorption suppression in postmenopausal women. The participants consumed either 1.0 or 0.5 g/day of rhamnose or placebo for 24 weeks, and BMD (lumbar spine and femur) and bone turnover markers were measured. After 24 weeks, the group consuming rhamnose 1.0 g/day exhibited a significantly higher BMD of the lumbar spine than the placebo group. Furthermore, the levels of tartrate-resistant acid phosphatase 5b, a bone resorption marker, were significantly lower in both rhamnose groups. These results indicated that rhamnose might contribute to the maintenance of BMD by suppressing bone resorption in healthy postmenopausal women (UMIN000046570).

Efficacy of AI-Guided (GenAISTM) Dietary Supplement Prescriptions versus Traditional Methods for Lowering LDL Cholesterol: A Randomized Parallel-Group Pilot Study.

Emerging evidence suggests that personalized dietary supplement regimens can significantly influence lipid metabolism and cardiovascular risk. The efficacy of AI-guided dietary supplement prescriptions, compared with standard physician-guided prescriptions, remains underexplored. In a randomized, parallel-group pilot study, 70 patients aged 40-75 years with LDL-C levels between 70 and 190 mg/dL were enrolled. Participants were randomized to receive either AI-guided dietary supplement prescriptions or standard physician-guided prescriptions for 90 days. The primary endpoint was the percent change in LDL-C levels. Secondary endpoints included changes in total cholesterol, HDL-C, triglycerides, and hsCRP. Supplement adherence and side effects were monitored. Sixty-seven participants completed the study. The AI-guided group experienced a 25.3% reduction in LDL-C levels (95% CI: -28.7% to -21.9%), significantly greater than the 15.2% reduction in the physician-guided group (95% CI: -18.5% to -11.9%; p < 0.01). Total cholesterol decreased by 15.4% (95% CI: -19.1% to -11.7%) in the AI-guided group compared with 8.1% (95% CI: -11.5% to -4.7%) in the physician-guided group (p < 0.05). Triglycerides were reduced by 22.1% (95% CI: -27.2% to -17.0%) in the AI-guided group versus 12.3% (95% CI: -16.7% to -7.9%) in the physician-guided group (p < 0.01). HDL-C and hsCRP changes were not significantly different between groups. The AI-guided group received a broader variety of supplements, including plant sterols, omega-3 fatty acids, red yeast rice, coenzyme Q10, niacin, and fiber supplements. Side effects were minimal and comparable between groups. AI-guided dietary supplement prescriptions significantly reduce LDL-C and triglycerides more effectively than standard physician-guided prescriptions, highlighting the potential for AI-driven personalization in managing hypercholesterolemia.

Pharmacopuncture therapy for adhesive capsulitis: A pragmatic randomized controlled pilot study

BackgroundAlthough several studies have reported the effectiveness of acupuncture treatment for adhesive capsulitis (AC), research on pharmacopuncture therapy for AC remains limited. We compared the effectiveness and safety of pharmacopuncture and physiotherapy for AC. MethodsThis pragmatic, randomized, controlled, parallel-group pilot study enrolled patients with limitations of shoulder movement and a numeric rating scale (NRS) score for shoulder pain ≥5 randomized (1:1) to the pharmacopuncture therapy (PPT) and physiotherapy (PT) groups. Treatment sessions were administered twice weekly for 6 weeks, and the participants were followed up for 13 weeks after randomization. The primary outcome was the NRS score for shoulder pain, and the secondary outcomes were the visual analog scale (VAS), Shoulder Pain and Disability Index (SPADI), range of motion (ROM), patient global impression of change (PGIC), EuroQol 5-Dimension 5-Level (EQ-5D-5L), and Short Form 12 Health Survey (SF-12) scores. The intention-to-treat (ITT) analysis was set as the primary analysis. ResultsAmong 50 participants, for the primary endpoint (week 7) the PPT group showed a significantly superior improvement in NRS, VAS, SPADI, ROM for flexion, ROM for abduction, and EQ-5D-5L scores. The ROM for extension, ROM for adduction, physical component summary, and patient global impression of change were significantly better in the PPT than in the PT group, and these effects were sustained until week 13. ConclusionIn this pilot study, PPT showed better effects than PT, confirming the feasibility of a follow-up main study. Trial registrationClinicaltrials.gov (NCT05292482) and cris.nih.go.kr (KCT0007198).

OPTIMA-BP: empOwering PaTients in MAnaging Blood Pressure – protocol for a randomised parallel group study comparing use of Kvatchii web-based patient education portal as an addition to home blood pressure monitoring

IntroductionHypertension is the leading modifiable risk factor for cardiovascular disease and is implicated in half of all strokes and myocardial infarctions. One-third of the adults in Scotland have hypertension yet...

Randomized, double-blind, placebo-controlled study to evaluate the effect of treatment with an SPMs-enriched oil on chronic pain and inflammation, functionality, and quality of life in patients with symptomatic knee osteoarthritis: GAUDI study

BackgroundSpecialized pro-resolving mediators (SPMs), including 18-HEPE, 17-HDHA, and 14-HDHA are recognized as potentially therapeutic in inflammatory diseases because SPMs regulate the inflammation process, which leads to, for example; swelling and the sensation of pain. In osteoarthritis (OA), chronic pain is described as the symptom that reduces patients´ quality of life (QoL). The GAUDI study evaluated the efficacy of SPMs supplementation in reducing pain in the symptomatic knee of OA patients.MethodsThis randomized, multicenter, double-blind, and placebo-controlled parallel-group pilot study was performed in Spain and conducted on adults 18–68 years old diagnosed with symptomatic knee OA. Patients were enrolled in the study for up to 24 weeks, which included a 12-week intervention period and a follow-up visit on week 24. The primary endpoint was pain change measured through a Visual Analog Scale (VAS). Secondary endpoints included: Pain change evaluation, stiffness, and function according to the WOMAC index; assessment of constant, intermittent, and total pain according to the OMERACT-OARSI score; evaluation of changes in health-related QoL parameters; the use or not of concomitant, rescue, and anti-inflammatory medication; and safety and tolerability assessments.ResultsPatients were enrolled in the study from May 2018 to September 2021. VAS pain score was evaluated in the per protocol population (n = 51 patients), in which we observed a statistically significant reduction after 8 weeks (p = 0.039) and 12 weeks (p = 0.031) of treatment in patients consuming SPMs (n = 23 subjects) vs. placebo (n = 28 subjects). In line with the OMERACT-OARSI score, intermittent pain was reduced after 12 weeks with statistical significance (p = 0.019) in patients treated with SPMs (n = 23 subjects) vs. placebo (n = 28 subjects). Functional status as WOMAC score did not significantly change after SPMs or placebo consumption. Notably, patients consuming SPMs showed improvements in all five aspects of the EUROQoL-5, including a significant improvement in the usual-activities dimension. None of the patients required rescue medication, nor were any adverse events reported.ConclusionsThese findings suggest that sustained SPMs consumption reduces pain in OA patients while also improving their Quality of Life. These results also support the safety profile of SPMs supplementation.Trial registration NCT05633849. Registered 1 December 1 2022. Retrospectively registered, https://clinicaltrials.gov/ct2/show/study/NCT05633849

Online Symptom Monitoring During Pelvic Radiation Therapy: Randomized Pilot Trial of the eRAPID Intervention

Radiation therapy (RT) and chemoRT for pelvic cancers increase survival but are associated with serious treatment-related symptoms. Electronic-patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is a secure online system for patients to self-report symptoms, generating immediate advice for hospital contact or self-management. This pilot study aimed to establish feasibility and acceptability of the system. In a prospective 2-center randomized parallel-group pilot study, patients undergoing radical pelvic RT for prostate cancer (prostateRT) or chemoRT for lower gastrointestinal and gynecological cancers were randomized to usual care (UC) or eRAPID (weekly online symptom reporting for 12, 18, and 24 weeks). Primary outcomes were recruitment/attrition, study completion, and patient adherence. Secondary outcomes were effect on hospital services and performance of patient outcome measures. Missing data, floor/ceiling effects, and mean change scores were examined for Functional Assessment of Cancer Therapy (FACT-G), European Organisation for Research and Treatment of Cancer, Quality of Life (EORTC QLQ C-30), self-efficacy, and EuroQol (EQ5D). From 228 patients approached, 167 (73.2%) were consented and randomized (83, eRAPID; 84, UC; 87, prostateRT; 80, chemoRT); 150 of 167 completed 24 study weeks. Only 16 patients (9.6%) withdrew (10, eRAPID; 6, UC). In the eRAPID arm, completion rates were higher in patients treated with prostateRT compared with chemoRT (week 1, 93% vs 69%; week 2, 93% vs 68%; week 12, 69% vs 55%). Overall, over 50% of online reports triggered self-management advice for milder adverse events. Unscheduled hospital contact was low, with no difference between eRAPID and UC.Return rates for outcome measures were excellent in prostateRT (97%-91%; 6-24 weeks) but lower in chemoRT (95%-55%; 6-24 weeks). Missing data were low (1%-4.1%), ceiling effects were evident in EQ5D-5L, self-efficacy-scale, and FACT-Physical Wellbeing. At 6 weeks, the chemoRT-eRAPID group showed less deterioration in FACT-G, EORTC QLQ-C30, and EQ5D-Visual Analogue Scale than UC, after baseline adjustment. eRAPID was successfully added to UC at 2 cancer centers in different patient populations. Acceptability and feasibility were confirmed with excellent adherence by prostate patients, but lower by those undergoing chemoRT for gynecological cancers.

Participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent: A parallel-group pilot study among Danish citizens

BackgroundTeleconsent via video conferencing enables decentralized trials with remote consent and has the additional benefit of allowing a real-time reaction to potential misunderstandings. However, participant acceptance of and satisfaction with teleconsent versus in-person consent processes are unknown. MethodsWe conducted a parallel-group pilot study to evaluate participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent among Danish citizens for a hypothetical research study. ResultsThere were no statistically significant differences in perceptions of security or satisfaction between teleconsent and in-person consent arms. However, participants viewed teleconsent as more convenient than in-person consent, as no transportation was needed and the process was less time-consuming. Recruitment was also faster in the teleconsent arm, and more people dropped out of the in-person arm, citing difficulties with transportation and time. ConclusionDecentralized clinical trials have been demonstrated to increase recruitment and enrollment rates, improve trial efficiency, and decrease dropout rates and trial delays. We add to this literature by suggesting that patients perceive teleconsent as similar to in-person consent, suggesting this is a feasible and acceptable substitution for in-person consent in multisite, decentralized trials. Future work should include patient perspectives from a larger, more diverse group of participants.

Eye Tracking in Patients with Parkinson's Disease Treated with Nabilone-Results of a Phase II, Placebo-Controlled, Double-Blind, Parallel-Group Pilot Study.

The topic of the therapeutic use of cannabinoids in Parkinson’s disease (PD) is broadly discussed and frequently comes up in the outpatient clinic. So far, there are only a few randomized clinical trials assessing the effects of cannabinoids in PD. We are able to demonstrate a reduction in non-motor symptom (NMS) burden after the administration of nabilone. As impairment of attention and working memory have been described earlier as possible side effects, we assess cognitive performance using saccadic paradigms measured by an eye tracker. We do not observe a significant difference in any of the saccadic paradigms between PD patients on placebo versus those treated with nabilone. We, therefore, conclude that top-down inhibitory control is not affected by the tetrahydrocannabinol analogue. Nabilone did not significantly worsen cognitive performance and appears to be safe to use in selected PD patients who suffer from disabling NMS.

A pilot study examining the efficacy of hochuekkito for improving quality of life in patients with myeloproliferative neoplasms.

The prognosis of Philadelphia chromosome-negative myeloproliferative neoplasms is relatively favorable, but the quality of life can be severely affected by myeloproliferative neoplasm-related symptoms such as fatigue, pruritus, night sweats, bone pain, fever and weight loss. In this study, we administered hochuekkito, a traditional herbal medicine, to patients with myeloproliferative neoplasms and investigated whether there was a reduction in myeloproliferative neoplasm-related symptoms. We conducted a randomized parallel-group pilot study. Patients were assigned to a hochuekkito administration or non-hochuekkito administration group. Myeloproliferative neoplasm-related symptoms based on Myeloproliferative Neoplasm Symptom Assessment Form total symptom score and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 were examined before hochuekkito administration and 4 and 8 weeks after administration. Among the 42 patients included in the analysis, 21 were assigned to the hochuekkito group and 21 were assigned to the control group. After administering hochuekkito, the median values of Myeloproliferative Neoplasms Symptom Assessment Form total symptom score at 4 and 8 weeks in the hochuekkito group demonstrated a decreasing trend; however, the difference between the two groups was not significant. In this study, we were unable to demonstrate significant differences between the hochuekkito and control groups in terms of the efficacy of hochuekkito in treating myeloproliferative neoplasm-related symptoms. However, there were cases that presented prominent improvement in symptoms in the hochuekkito group. The only reported adverse event was grade 1 impaired hepatic function. Therefore, hochuekkito might be a therapeutic option for patients with severely affected quality of life due to myeloproliferative neoplasm-related symptoms.

An Open-label Randomized Controlled Parallel-group Pilot Study Comparing the Immunogenicity of a Standard-, Double-, and Booster-dose Regimens of the 2014 Seasonal Trivalent Inactivated Influenza Vaccine in Kidney Transplant Recipients.

Immunogenicity of influenza vaccine in transplant recipients is suboptimal and alternative vaccination regimens are necessary. We compared the immunogenicity of a standard-dose trivalent inactivated influenza vaccination (SDTIIV), double-dose trivalent inactivated influenza vaccination (DDTIIV), and booster-dose trivalent inactivated influenza vaccination (BDTIIV) of the 2014 seasonal trivalent inactivated influenza vaccine in kidney transplant recipients. We randomized 176 participants to SDTIIV (59), DDTIIV (59), and BDTIIV regimens (58). Antibody titers were determined by hemagglutination inhibition at enrollment and 21 d postvaccination. Seroprotection rates (SPRs), seroconversion rates (SCRs), and geometric mean ratios (GMRs) were analyzed separately for participants with low (<1:40) and high (≥1:40) prevaccination antibody titers. Vaccination was confirmed for 172 participants. Immunogenicity analysis was done for 149 participants who provided postvaccination blood samples. In the subgroup with high prevaccination antibody titers, all vaccination regimens induced SPR > 70% to all antigens, but SCR and GMR were below the recommendations. In the subgroup with low prevaccination antibody titers, DDTIIV and BDTIIV regimens induced adequate SCR > 40% and GMR > 2.5 for all antigens, whereas SDTIIV achieved the same outcomes only for influenza B. SPRs were >70% only after DDTIIV (A/H1N1-77.8%) and BDTIIV (A/H3N2-77.8%). BDTIIV regimen independently increased seroprotection to A/H1N1 (PR = 2.58; P = 0.021) and A/H3N2 (PR = 2.21; P = 0.004), whereas DDTIIV independently increased seroprotection to A/H1N1 (PR = 2.59; P = 0.021). Our results suggest that DDTIIV and BDTIIV regimens are more immunogenic than SDTIIV, indicating the need for head-to-head multicenter clinical trials to further evaluate their efficacy.

The Feasibility of Action Observation and Repetitive Task Practice for Impairment, Function, and Spasticity Upper Limb Outcomes in Chronic Moderately Impaired Stroke Survivors

<h3>Research Objectives</h3> To determine the feasibility of Action Observation (AO) + Repetitive Task Practice (RTP) compared to placebo + RTP interventions through detecting changes in Upper Limb (UL) impairment, function, and spasticity outcomes in the chronic stroke survivor. <h3>Design</h3> Randomized controlled single-blinded, parallel-group pilot study. <h3>Setting</h3> Outpatient Rehabilitation. <h3>Participants</h3> 10 to AO + RTP group, 5 to Placebo Video + RTP. <h3>Interventions</h3> AO: Watch a 6 minute video of another person completing a functional task RTP: Repeated physical performance of the functional task in the AO video with the hemiplegic UL Placebo: Watch a 6 minute video of a series of changing static images without animals, human beings, or sound. Practice Schedule: 6 minutes video, 24 minutes RTP, 6 minutes video, 24 minutes RTP Subjects completed an intervention for 1 hour, 3 times/ week, for 8 weeks (total 24 sessions), and a daily 30 minute Home Exercise Program. Data collection at pretest, post intervention, and 1 month post intervention. <h3>Main Outcome Measures</h3> Upper Extremity Fugl Meyer (UEFM) (Primary Outcome Measure), Arm Motor Ability Test (AMAT), and Modified Ashworth Scale (MAS). <h3>Results</h3> There was a significantly larger improvement in the AO + RTP group at Post 2, with the difference in the average change in UEFM was 8.2 (90% CI 4.0 - 12.4, p=0.006), and change in the AMAT Functional Ability of 8.3 (90% CI 2.2 - 14.5, p=0.034). There was not significant evidence of improvement for MAS elbow flexion in the AO plus RTP group at Post 2 (p=0.060) or MAS elbow extension (p=0.055). <h3>Conclusions</h3> The response to intervention would indicate that a larger Phase III RCT should be completed to determine efficacy for the intervention in the moderately impaired chronic stroke survivor population. <h3>Author(s) Disclosures</h3> None Disclosed.

A randomized double-blind pilot study comparing cetirizine with diphenhydramine in the prevention of paclitaxel-associated infusion-related reactions.

e24080 Background: Cetirizine is a less sedative alternative to diphenhydramine for the prevention of infusion-related reactions (IRR) to paclitaxel. However, there is no prospective data to support its use in this context. In this study, we conducted a feasibility study for a future definitive non-inferiority trial comparing cetirizine with diphenhydramine as premedication to prevent paclitaxel-related IRR. Methods: This was a single center randomized double-blind parallel-group prospective pilot study. Participants were paclitaxel-naive cancer patients scheduled to start paclitaxel chemotherapy, alone or in combination. They were assigned to receive either intravenous diphenhydramine 50 mg + oral placebo (diphenhydramine group) or intravenous placebo + oral cetirizine 10 mg (cetirizine group) for their first two paclitaxel treatments. To assess the feasibility of a larger study, the percentage of eligible patients completing a first paclitaxel treatment and the recruitment rate were calculated. IRR events were documented. Change in drowsiness compared with baseline was assessed using the Stanford Sleepiness Scale (SSS). Results: Among 37 eligible patients, 27 were recruited and randomized (control 13; intervention 14) and 25 completed the study. The recruitment rate was 4.8 participants/month, meeting the primary feasibility target of 4 participants per month. One participant had an IRR (cetirizine group, CTCAE grade 2) and no unexpected serious adverse events occurred. Drowsiness was the main adverse effect associated with the premedication. The increase in drowsiness compared to baseline (ΔSSS) was greater in the diphenhydramine group compared to the cetirizine group (median ΔSSS 2 (IQR 3.25) vs median ΔSSS 0 (IQR 1), p &lt; 0.01) when measured one hour after the administration of the premedication. Patient self-assessed moderate or intense discomfort caused by drowsiness was exclusively reported in the diphenhydramine group, by 4 out of 13 participants. Conclusions: The trial methods were feasible in terms of recruitment rate, retention and patient safety. IRR were infrequent and a larger trial is warranted to confirm non-inferiority for IRR prevention. Cetirizine was significantly less sedating than diphenhydramine when administered as premedication to prevent paclitaxel-associated IRR. Clinical trial information: NCT04237090. [Table: see text]

Time-of-day effects of consumption of fish oil–enriched sausages on serum lipid parameters and fatty acid composition in normolipidemic adults: A randomized, double-blind, placebo-controlled, and parallel-group pilot study

ObjectivesThe body clock controls diurnal rhythms of nutrient digestion, absorption, and metabolism. Fish oil (FO) contains abundant ω-3 polyunsaturated fatty acids (PUFA), including docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), that are thought to lower triglyceride (TG) levels. This randomized, placebo-controlled, double-blind, parallel-group trial aimed to confirm the effects of the time of FO intake on TG in healthy Japanese adults. MethodsTwenty healthy Japanese adults (age, 20–60 y) were assigned to either a group that consumed sausages enriched with FO (DHA 1010 mg; EPA 240 mg) in the morning and a placebo (DHA 40 mg; EPA 15 mg) in the evening (BF-FO) or another group that consumed FO-enriched sausages in the evening and the placebo in the morning (DN-FO). Serum lipid parameters, fatty acid (FA) composition, and messenger RNA expression of lipogenic genes in circulating blood cells were evaluated in fasting blood samples before, as well as after 4 and 8 wk of FO intake. ResultsSerum concentrations of TG and total saturated FA were significantly decreased in the BF-FO group, whereas those of ω-3 PUFA were significantly and identically increased in both groups. Serum concentrations of ω-6 PUFA were significantly decreased in the BF-FO but not the DN-FO group. Messenger RNA expression of the lipogenic genes ACLY, SCD, and FASN were similarly reduced in both groups. ConclusionsThese findings suggested that the timing of FO intake affects both serum FA concentrations and TG metabolism in normolipidemic humans. The mechanisms of these effects of FO on lipid metabolism require further investigation.

Mobile app-based chatbot to deliver cognitive behavioral therapy and psychoeducation for adults with attention deficit: A development and feasibility/usability study

BackgroundAttention deficit is a growing problem in adults, and early diagnosis and treatment are needed. Previous studies have shown that cognitive behavioral therapy (CBT) is effective in improving attention deficit symptoms. However, many patients are not receiving adequate treatment due to time, space, and cost constraints. Recently, in other mental illnesses, mobile-based chatbots delivering CBT and psychoeducation have been used for symptom mitigation and treatment. ObjectiveThis study aimed to investigate the feasibility and usability of a short-term intervention, specifically a mobile-based interactive chatbot application, in alleviating attention deficit symptoms. MethodsThis was a randomized, non-blind parallel-group pilot study conducted from September 2019 to March 2020. Forty-six individuals with attention deficit aged 19–60 were randomly allocated to the chatbot (n = 23) and information-only control groups (n = 23) for 4 weeks. The former group was instructed to use the chatbot application “Todaki,” while the latter group was provided with a book on managing attention deficit symptoms. Participants were administered questionnaires to assess their symptoms of attention deficit, depression, and anxiety and evaluated at baseline and 4 weeks after the intervention. The post-intervention survey assessed the chatbot’s usability, acceptability, and side effects. ResultsThe average age of the participants was 25.1 years (standard deviation [SD] 7.5 years), and 56.5 % (26/46) participants were female. Intention-to-treat analysis (chatbot, n = 23; control, n = 23) revealed a significant reduction of attention deficit symptoms only in the chatbot group, which is represented by group-by-time interaction in Conner’s Adult ADHD Rating Scale subscales of Diagnostic and Statistical Manual-IV Attention-Deficit/Hyperactivity Disorder (ADHD) Hyperactive-Impulsive symptoms (F = 4.39; p = .04) and ADHD symptoms total (F = 6.74, p = .01). Further, the results of the paired t-test were significant only in the chatbot group. The average number of times the chatbots were used in 4 weeks was 20.32 (SD 12.89). The total average usage time was 1 h 15 min (SD 1 h 20 min). The degree of improvement in the ADHD symptoms total score was correlated with the number of times the psychoeducation program was used. According to the participants, the empathic/friendly character and unnatural flow of conversation were the best and worst features of the chatbot, respectively. ConclusionsThis study identified the feasibility and usability of using the mobile-based chatbot to improve attention deficit and its associated psychiatric symptoms. Using this novel intervention to conduct CBT would provide a useful digital therapeutic tool that allows easy accessibility and self-guided management for people with attention deficit, which should be verified through the large scale randomized controlled trial.

A randomized open label parallel group pilot study to evaluate efficacy of Ayurveda interventions in the management of asymptomatic and mild COVID-19 patients-experiences of a Lucknow based level 2 hospital of Uttar Pradesh, India

BackgroundSARS--CoV-2 has emerged as a global threat since its onset in December 2019. India has also been severely affected by the dreadful Corona Virus and is currently battling one of the worst pandemics of history. WHO and the world medical fraternity are putting their efforts to materialize a treatment or vaccine for this novel virus. A randomized open label parallel group study was designed in a Lucknow based level 2 COVID hospital to evaluate the efficacy of Ayurvedic interventions in the management of asymptomatic and mild COVID 19 patients. ObjectiveTo evaluate the efficacy of Ayurveda in the management of mildly affected COVID-19 patients. Materials and methodsThe current trial was an open label randomized 10-day study. Total 120 asymptomatic and/or mild COVID-19 positive patients fulfilling inclusion criteria were randomly grouped into three. RT-PCR of all the patients were done on 5th, 7th and on 10th day respectively. The observations were noted and results were analyzed statistically. Kruskal–Wallis test and Wilcoxon Sign rank test were used for data analysis where applicable. ResultsImprovement in symptoms, enhancement in Agni and recovery from COVID infection was observed. The results obtained were encouraging and showed better viral clearance and control of symptom progression in the patients placed on Ayurvedic medications. ConclusionThe promising results in the study showed that an approach involving Ayurveda can be helpful for the management of the mild COVID-19 patients. Ayurveda can be used to limit community spread and check disease progression to a more appalling state. Trial registrationTrial was registered with Clinical Trials Registry- India (CTRI registration number: CTRI/2020/06/025800.

Effects and feasibility of hyperthermic baths in comparison to exercise as add-on treatment to usual care in depression: a randomised, controlled pilot study

BackgroundLimitations of current therapy of depression highlight the need for an immediately available, easily implementable add-on treatment option with high acceptance from patients. Hyperthermic baths (HTB) are a form of balneotherapy with head-out-of-water-immersion in a hot pool or tub at 40 °C for 15–20 min. A prior study suggests that HTB added to usual depression care can have antidepressant effects.MethodSingle-site, open-label randomised controlled 8-week parallel-group pilot study at a university outpatient clinic. 45 medically stable outpatients with moderate depression as determined by the 17-item Hamilton Depression Rating Scale (HAM-D) score ≥ 18 and a score ≥ 2 on item 1 (Depressed Mood) were recruited. They were randomised to twice weekly HTB (n = 22) or a physical exercise program (PEP) of moderate intensity (n = 23). Primary outcome measure was the change in HAM-D total score from baseline (T0) to the 2-week time point (T1). Linear regression analyses, adjusted for baseline values, were performed to estimate intervention effects on an intention-to-treat (ITT) and per-protocol (PP) principle.ResultsForty-five patients (HTB n = 22; PEP n = 23) were analyzed according to ITT (mean age = 48.4 years, SD = 11.3, mean HAM-D score = 21.7, SD = 3.2). Baseline-adjusted mean difference after 2 weeks was 4.3 points in the HAM-D score in favor of HTB (p < 0.001). Compliance with the intervention and follow-up was far better in the HTB group (2 vs 13 dropouts). Per protocol analysis only showed superiority of HTB as a trend (p = 0.068). There were no treatment-related serious adverse events. Main limitation: the number of dropouts in the PEP group (13 of 23) was higher than in other trials investigating exercise in depression. Due to the high number of dropouts the effect in the ITT-analysis may be overestimated.ConclusionsHTB added to usual care may be a fast-acting, safe and easy accessible method leading to clinically relevant improvement in depression severity after 2 weeks; it is also suitable for persons who have problems performing exercise training.Trial registrationGerman Clinical Trials Register (DRKS) with the registration number DRKS00011013 (registration date 2016-09-19) before onset of the study.

Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage

AsbtractBackgroundThere are limited neuroprotective treatment options for patients with aneurysmal subarachnoid hemorrhage (SAH). Cerebrolysin, a brain-specific proposed pleiotropic neuroprotective agent, has been suggested to improve global functional outcomes in ischemic stroke. We investigated the efficacy, safety and feasibility of administering Cerebrolysin for SAH patients.MethodsThis was a prospective, randomized, double-blind, placebo-controlled, single-center, parallel-group pilot study. Fifty patients received either daily Cerebrolysin (30 ml/day) or a placebo (saline) for 14 days (25 patients per study group). The primary endpoint was a favorable Extended Glasgow Outcome Scale (GOSE) of 5 to 8 (moderate disability to good recovery) at six-months. Secondary endpoints included the modified Ranking Scale (mRS), the Montreal Cognitive Assessment (MOCA) score, occurrence of adverse effects and the occurrence of delayed cerebral ischemia (DCI).ResultsNo severe adverse effects or mortality attributable to Cerebrolysin were observed. No significant difference was detected in the proportion of patients with favorable six-month GOSE in either study group (odds ratio (OR): 1.49; 95% confidence interval (CI): 0.43–5.17). Secondary functional outcome measures for favorable six-month recovery i.e. a mRS of 0 to 3 (OR: 3.45; 95% CI 0.79–15.01) were comparable for both groups. Similarly, there was no difference in MOCA neurocognitive performance (p-value: 0.75) and in the incidence of DCI (OR: 0.85 95% CI: 0.28–2.59).ConclusionsUse of Cerebrolysin in addition to standard-of-care management of aneurysmal SAH is safe, well tolerated and feasible. However, the neutral results of this trial suggest that it does not improve the six-month global functional performance of patients.Clinical trial registrationName of Registry: ClinicalTrials.govTrial Registration Number: NCT01787123.Date of Registration: 8th February 2013.

Effectiveness of Abhaya Sunthi Churna and Snehana Swedana in Tamaka Shwasa: a randomized parallel group pilot study

Effectiveness of Abhaya Sunthi Churna and Snehana Swedana in Tamaka Shwasa: a randomized parallel group pilot study

A Randomized Pilot Clinical Assessment Of Three Skincare Regimens On Skin Conditions In Infants.

IntroductionFew data are available on the comparison between the effects on infant skin of skin care products and those of water alone.Patients and methodsIn this single-center, evaluator-blind, parallel-group pilot study, healthy infants were randomized to near-daily washing for 12 weeks (starting in the summer and finishing in the winter months) with a mild liquid baby wash followed by use of baby lotion (wash+lotion), water followed by baby lotion (water+lotion), or water alone. Clinical and instrumental assessments of skin moisturization and barrier function were made.ResultsAs expected the skin condition in all groups was affected by the change of the season. The skin of infants in all groups was mildly deteriorated (clinical grading) and with reduced moisture levels and increased barrier function. Instrumental measurements indicated that skin moisture and barrier function were better maintained in the wash+lotion and water+lotion groups than in the water-only group at week 12. Clinical assessment scores increased slightly over 12 weeks in all groups (P<0.05). At week 12, the wash+lotion group (n = 44) had significantly less change from baseline in overall skin condition and softness (lower scores) than did the water+lotion (n = 43) or water-only (n = 43) groups. The wash+lotion regimen maintained stable erythema and rash scores with lower mean values over time than in the other groups.ConclusionA regimen of a liquid baby wash and a baby skin lotion for 12 weeks resulted in less detrimental changes in instrumental and clinical measures of skin than using water and lotion or water alone.