scholarly journals Extended Support Within a Person-Centered Practice After Surgery for Patients With Pituitary Tumors: Protocol for a Quasiexperimental Study (Preprint)

2020 ◽  
Author(s):  
Sofie Jakobsson ◽  
Daniel S Olsson ◽  
Eva Andersson ◽  
Tobias Hallén ◽  
David Krabbe ◽  
...  
Keyword(s):  
Standard Care ◽  
Pituitary Tumors ◽  
Standard Of Care ◽  
Self Management ◽  
Control Group ◽  
Management Support ◽  
Patient Support ◽  
Person Centered Care ◽  
Patient Reported ◽  
Centered Care

BACKGROUND Patients with pituitary tumors often live with lifelong consequences of their disease. Treatment options include surgery, radiotherapy, and medical therapy. Symptoms associated with the tumor or its treatment affect several areas of life. Patients need to adhere to long-term contact with both specialist and general health care providers due to the disease, complex treatments, and associated morbidity. The first year after pituitary surgery constitutes an important time period, with medical evaluations after surgery and decisions on hormonal substitution. The development and evaluation of extended patient support during this time are limited. OBJECTIVE The aim of this study is to evaluate whether support within a person-centered care practice increases wellbeing for patients with pituitary tumors. Our main hypothesis is that the extended support will result in increased psychological wellbeing compared with the support given within standard of care. Secondary objectives are to evaluate whether the extended support, compared with standard care, will result in (1) better health status, (2) less fatigue, (3) higher satisfaction with care, (4) higher self-efficacy, (5) increased person-centered content in care documentation, and (6) sustained patient safety. METHODS Within a quasiexperimental design, patients diagnosed with a pituitary tumor planned for neurosurgery are consecutively included in a pretest-posttest study performed at a specialist endocrine clinic. The control group receives standard of care after surgery, and the interventional group receives structured patient support for 1 year after surgery based on person-centeredness covering self-management support, accessibility, and continuity. A total of 90 patients are targeted for each group. RESULTS Recruitment into the control group was performed between Q3 2015 and Q4 2017. Recruitment into the intervention group started in Q4 2017 and is ongoing until Q4 2020. The study is conducted according to the Declaration of Helsinki, and the protocol has received approval from a regional ethical review board. CONCLUSIONS This study entails an extensive intervention constructed in collaboration between clinicians, patients, and researchers that acknowledges accessibility, continuity, and self-management support within person-centeredness. The study has the potential to compare standard care to person-centered practice adapted specifically for patients with pituitary tumors and evaluated with a combination of patient-reported outcomes and patient-reported experience measures. Following the results, the person-centered practice may also become a useful model to further develop and explore person-centered care for patients with other rare, lifelong conditions. CLINICALTRIAL Researchweb.org. https://www.researchweb.org/is/sverige/project/161671 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17697

scholarly journals Extended Support Within a Person-Centered Practice After Surgery for Patients With Pituitary Tumors: Protocol for a Quasiexperimental Study

10.2196/17697 ◽  
2020 ◽  
Vol 9 (7) ◽  
pp. e17697 ◽  
Author(s):  
Sofie Jakobsson ◽  
Daniel S Olsson ◽  
Eva Andersson ◽  
Tobias Hallén ◽  
David Krabbe ◽  
...  
Keyword(s):  
Standard Care ◽  
Pituitary Tumors ◽  
Standard Of Care ◽  
Self Management ◽  
Control Group ◽  
Management Support ◽  
Patient Support ◽  
Person Centered Care ◽  
Patient Reported ◽  
Centered Care

Background Patients with pituitary tumors often live with lifelong consequences of their disease. Treatment options include surgery, radiotherapy, and medical therapy. Symptoms associated with the tumor or its treatment affect several areas of life. Patients need to adhere to long-term contact with both specialist and general health care providers due to the disease, complex treatments, and associated morbidity. The first year after pituitary surgery constitutes an important time period, with medical evaluations after surgery and decisions on hormonal substitution. The development and evaluation of extended patient support during this time are limited. Objective The aim of this study is to evaluate whether support within a person-centered care practice increases wellbeing for patients with pituitary tumors. Our main hypothesis is that the extended support will result in increased psychological wellbeing compared with the support given within standard of care. Secondary objectives are to evaluate whether the extended support, compared with standard care, will result in (1) better health status, (2) less fatigue, (3) higher satisfaction with care, (4) higher self-efficacy, (5) increased person-centered content in care documentation, and (6) sustained patient safety. Methods Within a quasiexperimental design, patients diagnosed with a pituitary tumor planned for neurosurgery are consecutively included in a pretest-posttest study performed at a specialist endocrine clinic. The control group receives standard of care after surgery, and the interventional group receives structured patient support for 1 year after surgery based on person-centeredness covering self-management support, accessibility, and continuity. A total of 90 patients are targeted for each group. Results Recruitment into the control group was performed between Q3 2015 and Q4 2017. Recruitment into the intervention group started in Q4 2017 and is ongoing until Q4 2020. The study is conducted according to the Declaration of Helsinki, and the protocol has received approval from a regional ethical review board. Conclusions This study entails an extensive intervention constructed in collaboration between clinicians, patients, and researchers that acknowledges accessibility, continuity, and self-management support within person-centeredness. The study has the potential to compare standard care to person-centered practice adapted specifically for patients with pituitary tumors and evaluated with a combination of patient-reported outcomes and patient-reported experience measures. Following the results, the person-centered practice may also become a useful model to further develop and explore person-centered care for patients with other rare, lifelong conditions. Trial Registration Researchweb.org. https://www.researchweb.org/is/sverige/project/161671 International Registered Report Identifier (IRRID) DERR1-10.2196/17697

scholarly journals The effectiveness of nurse-led self-management support program for people with chronic kidney disease stage 3-4 (CKD-NLSM): Study protocol for a randomized controlled trial

2021 ◽  
Vol 104 (2) ◽  
pp. 003685042110261
Author(s):  
Al Sawad Ayat Ali ◽  
Soo Kun Lim ◽  
Li Yoong Tang ◽  
Aneesa Abdul Rashid ◽  
Boon-How Chew
Keyword(s):  
Kidney Disease ◽  
Controlled Trial ◽  
Self Management ◽  
Control Group ◽  
Management Support ◽  
Disease Knowledge ◽  
Management Intervention ◽  
Randomized Controlled ◽  
Ckd Stage ◽  
Management Behaviors

The complexity of chronic kidney disease (CKD) and its treatments have made self-management behaviors inevitably challenging. However, supplementing education with self-management skills may improve numerous health outcomes in people with nondialysis CKD. This study protocol describes a randomized controlled trial (RCT) aimed to evaluate the effects of a nurse-led self-management support program as an intervention for kidney disease knowledge and CKD self-management behaviors among people with pre-dialysis CKD. In Phase 1, people with CKD stage 3–4 and their family members are involved in co-designing, development and pilot testing of a theory-based self-management intervention. In Phase 2, we perform a cross-cultural adaptation of the Kidney Disease Knowledge Survey, CKD Self-Management and Self-efficacy for Managing Chronic Disease questionnaires. In Phase 3, a parallel RCT will be conducted to evaluate the intervention where 154 participants with CKD stage 3–4 will be randomly assigned to either the intervention ( n = 77) or control group ( n = 77). The intervention group will receive 6-week self-management program from a nurse-coach in addition to standard usual care, while the control group will receive only standard usual care. Outcome measures include kidney disease knowledge, CKD self-management behavior, self-efficacy, quality of life, blood pressure control and adherence to CKD diet as indicated by 24-h urine urea nitrogen, 24-h urine sodium and net endogenous acid production. Data will be collected at baseline and 12-week post-baseline. The between- and within-group intervention effects will be estimated using the Generalized Estimating Equations. The self-management intervention offers strategies to delay CKD progression and to encourage motivation to better self-manage at home. This study integrates self-management education and psychosocial support with culturally relevant scenarios, and evaluates important self-reported and objective outcomes. Clinical Trials Registration: www.ClinicalTrials.gov , identifier: NCT03974646.

scholarly journals 83 A Medication Self-Management Intervention to Improve Medication Adherence For Older People with Multimorbidity: A Pilot Study

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i12-i42
Author(s):  
C Yang ◽  
Z Hui ◽  
S Zhu ◽  
X Wang ◽  
G Tang ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Pilot Study ◽  
Older People ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Medication Knowledge ◽  
Management Intervention ◽  
Patient Reported

Abstract Introduction Medication self-management support has been recognised as an essential element in primary health care to promote medication adherence and health outcomes for older people with chronic conditions. A patient-centred intervention empowering patients and supporting medication self-management activities could benefit older people. This pilot study tested a newly developed medication self-management intervention for improving medication adherence among older people with multimorbidity. Method This was a two-arm randomised controlled trial. Older people with multimorbidity were recruited from a community healthcare centre in Changsha, China. Participants were randomly allocated to either a control group receiving usual care (n = 14), or to an intervention group receiving three face-to-face medication self-management sessions and two follow-up phone calls over six weeks, targeting behavioural determinants of adherence from the Information-Motivation-Behavioural skills model (n = 14). Feasibility was assessed through recruitment and retention rates, outcome measures collection, and intervention implementation. Follow-up data were measured at six weeks after baseline using patient-reported outcomes including medication adherence, medication self-management capabilities, treatment experiences, and quality of life. Preliminary effectiveness of the intervention was explored using generalised estimating equations. Results Of the 72 approached participants, 28 (38.89%) were eligible for study participation. In the intervention group, 13 participants (92.86%) completed follow-up and 10 (71.42%) completed all intervention sessions. Ten participants (71.42%) in the control group completed follow-up. The intervention was found to be acceptable by participants and the intervention nurse. Comparing with the control group, participants in the intervention group showed significant improvements in medication adherence (β = 0.26, 95%CI 0.12, 0.40, P < 0.001), medication knowledge (β = 4.43, 95%CI 1.11, 7.75, P = 0.009), and perceived necessity of medications (β = −2.84, 95%CI -5.67, −0.01, P = 0.049) at follow-up. Conclusions The nurse-led medication self-management intervention is feasible and acceptable among older people with multimorbidity. Preliminary results showed that the intervention may improve patients’ medication knowledge and beliefs and thus lead to improved adherence.

scholarly journals The Effect of Dietary and Exercise Self-Management Support Program on Dietary Behavior Exercise Behavior and Clinical Outcomes in Muslim Patients with Poorly Controlled Type 2 DM in a Community Setting in Indonesia

2015 ◽  
Vol 5 (1) ◽  
pp. 1 ◽  
Author(s):  
Rian Adi Pamungkas ◽  
Tippamas Chinnawong ◽  
Charuwan Kritpracha
Keyword(s):  
Clinical Outcomes ◽  
Dietary Behavior ◽  
Exercise Behavior ◽  
Support Program ◽  
Self Management ◽  
Control Group ◽  
Management Support ◽  
Type 2 Dm ◽  
Experimental Group

Purpose: The objective of this study was to examine the effect of dietary and exercise self-management support program on the dietary behavior, exercise behavior, and clinical outcomes of Muslim patients with poorly controlled type 2 DM in Indonesia. Methods: This study was a quasi-experimental, two group, pre-test and post-test design. The experimental group received the dietary and exercise self-management support program and usual care, whereas the control group only received the usual nursing care.Result: 35 subjects in the experimental group and 35 subjects in the control group completed the program, respectively. The findings indicated that there are significantly differences in dietary behavior (p=.00), exercise behavior (p=.00) and clinical outcomes: fasting blood glucose (FBG) (p=.00), cholesterol total level (p=.01) and systolic blood pressure (p=.00) between the experimental group and control group. However, for the BMI status (p=.84) and diastolic blood pressure (BP) (p=.32) were no significant differences between two groups. Conclusion: The dietary and exercise self-management support program was effective for improving the dietary behavior, exercise behavior, FBG, and total cholesterol level for individuals with poorly controlled type 2 diabetes mellitus. Further studies should be replicated using larger groups over a longer time frame.

scholarly journals Deriving and validating a brief measure of treatment burden to assess person-centered healthcare quality in primary care: a multi-method study

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
David T. Eton ◽  
Mark Linzer ◽  
Deborah H. Boehm ◽  
Catherine E. Vanderboom ◽  
Elizabeth A. Rogers ◽  
...  
Keyword(s):  
Primary Care ◽  
Health Status ◽  
Medication Adherence ◽  
Care Quality ◽  
Community Dwelling ◽  
Self Management ◽  
Treatment Burden ◽  
Person Centered Care ◽  
Centered Care

Abstract Background In primary care there is a need for more quality measures of person-centered outcomes, especially ones applicable to patients with multiple chronic conditions (MCCs). The aim of this study was to derive and validate a short-form version of the Patient Experience with Treatment and Self-management (PETS), an established measure of treatment burden, to help fill the gap in quality measurement. Methods Patient interviews (30) and provider surveys (30) were used to winnow items from the PETS (60 items) to a subset targeting person-centered care quality. Results were reviewed by a panel of healthcare providers and health-services researchers who finalized a pilot version. The Brief PETS was tested in surveys of 200 clinic and 200 community-dwelling MCC patients. Surveys containing the Brief PETS and additional measures (e.g., health status, medication adherence, quality of care, demographics) were administered at baseline and follow-up. Correlations and t-tests were used to assess validity, including responsiveness to change of the Brief PETS. Effect sizes (ES) were calculated on mean differences. Results Winnowing and panel review resulted in a 34-item Brief PETS pilot measure that was tested in the combined sample of 400 (mean age = 57.9 years, 50% female, 48% white, median number of conditions = 5). Reliability of most scales was acceptable (alpha > 0.70). Brief PETS scores were associated with age, income, health status, and quality of chronic illness care at baseline (P < .05; rho magnitude range: 0.16–0.66). Furthermore, Brief PETS scores differentiated groups based on marital and education status, presence/absence of a self-management routine, and optimal/suboptimal medication adherence (P < .05; ES range: 0.25–1.00). Declines in patient-reported physical or mental health status over time were associated with worsening PETS burden scores, while improvements were associated with improving PETS burden scores (P < .05; ES range: 0.04–0.44). Among clinic patients, 91% were willing to complete the Brief PETS as part of their clinic visits. Conclusions The Brief PETS (final version: 32 items) is a reliable and valid tool for assessing person-centered care quality related to treatment burden. It holds promise as a means of giving voice to patient concerns about the complexity of disease management.

Person-centered peritoneal dialysis prescription and the role of shared decision-making

2020 ◽  
Vol 40 (3) ◽  
pp. 302-309 ◽  
Author(s):  
Peter G Blake ◽  
Edwina A Brown
Keyword(s):  
Decision Making ◽  
Peritoneal Dialysis ◽  
Shared Decision Making ◽  
Care Delivery ◽  
Shared Decision ◽  
Person Centered Care ◽  
Modern Health Care ◽  
Patient Reported ◽  
Centered Care ◽  
End Stage

Person-centered care has become a dominant paradigm in modern health care. It needs to be applied to people with end-stage kidney disease considering the initiation of dialysis and to peritoneal dialysis (PD) prescription and care delivery. It is relevant to their decisions about goals of care, transplantation, palliative care, and discontinuation of dialysis. It is also relevant to decisions about how PD is delivered, including options such as incremental PD. Shared decision-making is the essence of this process and needs to become a standard principle of care. It requires engagement, education, and empowerment of patients. Patient-reported outcomes and patient-reported experience are also central to person-centered care in PD.

scholarly journals Web-based self-management support prototype My Kidneys My Health for adults with chronic kidney disease: Co-design and usability testing (Preprint)

2020 ◽  
Author(s):  
Maoliosa Donald ◽  
Heather Beanlands ◽  
Sharon Straus ◽  
Michelle Smekal ◽  
Sarah Gil ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Focus Groups ◽  
Usability Testing ◽  
Video Production ◽  
Self Management ◽  
Management Support ◽  
Web Based ◽  
Support Tool ◽  
Patient Reported

BACKGROUND Supporting patients to self-manage their chronic kidney disease (CKD) has been identified as a research priority by patients with CKD and those that care for them. Self-management has been shown to slow CKD progression and improve the quality of life for individuals living with the disease. Previous work has identified a need for a person-centered, theory-informed web-based tool for CKD self-management that can be individualized to a patient’s unique situation, priorities, and preferences. We addressed this gap using an Integrated Knowledge Translation method and patient engagement principles. OBJECTIVE The aim of this study was to implement the systematic co-design and usability testing of a web-based self-management prototype for adults with CKD (non-dialysis, non-transplant) and their caregivers to enhance self-management support. METHODS A multi-step, iterative system development cycle was used to co-design and test My Kidneys My Health prototype. The 3-step process included: (1) creating website features and content using two sequential focus groups with patients with CKD and caregivers; (2) heuristic testing using Nielsen’s 10 heuristic principles; (3) usability testing through in-person 60-minute interviews with patients with CKD and a caregiver. Patients with CKD, caregivers, clinicians, researchers, software developers, graphic designers, and policy makers were involved in all steps of this study. RESULTS In step 1, 18 participants (14 patients and 4 caregivers) attended one of the two sequential focus groups. The participants provided specific suggestions for simplifying navigation, as well as suggestions to incorporate video, text, audio, interactive components, and visuals to convey information. Five reviewers completed the heuristic analysis (step 2), identifying items mainly related to navigation and functionality. Five participants completed usability testing (step 3) and provided feedback on video production, navigation, features and functionality, and branding. Participants reported visiting the website repeatedly for the following features: personalized food tool, my health care provider question list, symptom guidance based on CKD severity, and medication advice. Usability was high, with a mean System Usability Score of 90 out of 100. CONCLUSIONS My Kidneys My Health prototype is a systematically developed, multi-faceted CKD self-management web-based support tool guided by theory and preferences of patients with CKD and their caregivers. The website is user-friendly and provides features that improve the user experience by tailoring the content and resources to their needs. A feasibility study will provide insight into the acceptability of and engagement with the prototype, and identify preliminary patient reported outcomes (e.g., self-efficacy), as well as potential factors related to implementation. This work is relevant given the shift to virtual care during a pandemic era, providing patients with support when in-person care is restricted. CLINICALTRIAL

scholarly journals Enterosgel for the treatment of adults with acute diarrhoea in a primary care setting: a randomised controlled trial

2019 ◽  
Vol 6 (1) ◽  
pp. e000287 ◽  
Author(s):  
Carol Angela Howell ◽  
Elena Markaryan ◽  
Victoria Allgar ◽  
Anu Kemppinen ◽  
Aleksander Khovanov ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Acute Diarrhoea ◽  
Control Group ◽  
Number Needed To Treat ◽  
Symptom Duration ◽  
High Morbidity ◽  
Patient Reported ◽  
Randomised Controlled

BackgroundAcute intestinal infections are common conditions causing high morbidity and mortality especially in the young and elderly, resulting in a significant burden on health service resources and the economy. Current National Institute for Health and Care Excellence guidance are fluid and nutritional management; however, this does not reduce the duration of diarrhoea and the challenge of treating diarrhoea itself remains. We investigated the efficacy, tolerability and safety of intestinal adsorbent Enterosgel (polymethylsiloxane polyhydrate) compared with standard care in adults with acute diarrhoea.MethodsThis was a randomised controlled trial enrolling 105 subjects to receive the medical device Enterosgel up to six times daily for up to 8 days with standard care (oral rehydration solution), or standard care alone. The primary endpoint was the duration of diarrhoea (hours) from randomisation to first non-loose stool in the Enterosgel versus control group.ResultsA total of 51 subjects were randomised into the Enterosgel group and 54 into the control group, after excluding missing data, the data from 43 subjects in each group were analysed. Duration of diarrhoea was significantly shorter in the Enterosgel group at 27 hours versus 39 hours in the control group (HR was 1.74 [95% CI 1.06 to 2.87]) (p=0.03). This yielded a number needed to treat value of 5. Enterosgel was well tolerated and safe with no serious adverse events. One serious diarrhoea-related event resulting in hospitalisation was reported in the control group.ConclusionsEnterosgel treatment was associated with a significant reduction in the duration of diarrhoea in adults with patient-reported acute diarrhoea, compared with standard care. These findings support the role of Enterosgel in acute diarrhoea especially in vulnerable groups where rapid resolution of symptoms is required. Reduction in symptom duration could translate to less healthcare costs and socioeconomic burden.Trial registration numberISRCTN20758708

scholarly journals The Effect of the Interactive Mobile Health and Rehabilitation System on Health and Psychosocial Outcomes in Spinal Cord Injury: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Michael Alan Kryger ◽  
Theresa M Crytzer ◽  
Andrea Fairman ◽  
Eleanor J Quinby ◽  
Meredith Karavolis ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Health Outcomes ◽  
Mobile Health ◽  
Standard Care ◽  
Intervention Group ◽  
Psychosocial Outcomes ◽  
Self Management ◽  
Control Group ◽  
Cord Injury

BACKGROUND Individuals with spinal cord injury (SCI) are at risk for secondary medical complications, such as urinary tract infections (UTIs) and pressure injuries, that could potentially be mitigated through improved self-management techniques. The Interactive Mobile Health and Rehabilitation (iMHere) mobile health (mHealth) system was developed to support self-management for individuals with disabilities. OBJECTIVE The main objective of this study was to determine if the use of iMHere would be associated with improved health outcomes over a 9-month period. A secondary objective was to determine if the use of iMHere would be associated with improved psychosocial outcomes. Phone usage, app usage, and training time data were also collected to analyze trends in iMHere use. METHODS Overall, 38 participants with SCI were randomized into either the intervention group who used the iMHere system and received standard care or the control group who received standard care without any technology intervention. Health outcomes were recorded for the year before entry into the study and during the 9 months of the study. Participants completed surveys at baseline and every 3 months to measure psychosocial outcomes. RESULTS The intervention group had a statistically significant reduction in UTIs (0.47 events per person; P=.03; number needed to treat=2.11). Although no psychosocial outcomes changed significantly, there was a nonsignificant trend toward a reduction in mood symptoms in the intervention group compared with the control group meeting the threshold for clinical significance. Approximately 34 min per participant per month were needed on average to manage the system and provide technical support through this mHealth system. CONCLUSIONS The use of the iMHere mHealth system may be a valuable tool in the prevention of UTIs or reductions in depressive symptoms. Given these findings, iMHere has potential scalability for larger populations. CLINICALTRIAL ClinicalTrials.gov NCT02592291; https://clinicaltrials.gov/ct2/show/NCT02592291.

scholarly journals Safety and Efficacy of Repurposed Siddha Medicines in Mild, Moderate, and Severe COVID-19 Patients Admitted To a Government Tertiary Hospital Near Chennai, Tamil Nadu– An Open-Labeled, Randomized, Controlled Trial.

2021 ◽  
Author(s):  
Christian G J ◽  
Meenakumari Ramasamy ◽  
Shanthimalar Ramalingam ◽  
Sankar Ganesan ◽  
Ravichandran Vadugam Muthusamy ◽  
...  
Keyword(s):  
Treatment Group ◽  
Standard Care ◽  
Tamil Nadu ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Tertiary Hospital ◽  
Control Group ◽  
Open Label ◽  
Randomized Controlled ◽  
Oxygenation Status

Abstract BackgroundCOVID-19 resulted in loss of human lives owing to respiratory failure caused by dysregulated immune system. Though many treatments are evaluated, the most appropriate is yet to be established. We hypothesized accelerated recovery and reduced mortality in mild, moderate and severe COVID-19 with Siddha regimen consisting of natural products.MethodsIn a randomized, controlled open-label trial conducted on 200 hospitalized COVID-19 patients, they were allocated equally to be treated with add-on Siddha regimen with Standard care or only standard care. The primary and secondary end points were accelerated recovery (≤ 7 days) and mortality comparison between the groups respectively. Patients were followed through 90 days.ResultsIn this study the accelerated recovery was 59.0% and 27.0% in treatment and control group (ITT analyses) (p < 0.001) respectively and Odds for it were four times higher in the treatment group (OR: 3.9; 95% CI: 1.9, 8.0). The estimated median time for recovery in the treatment group was 7 days (95% CI: 6.0, 8.0; p=0.003) and 10 days (95% CI: 8.7, 11.3) in control. Hazard ratio for death in control was 2.3 times that of treatment group. No adverse reactions or alarming laboratory values were observed in response to intervention. In severe treatment group (n=80), mortality was 15.0% and 39.5% in control (n=81). The COVID stage progression was 65% less in treatment group.ConclusionSiddha regimen demonstrated that they can synergistically improve oxygenation status, enhance the recovery rate and reduce the mortality better as compared to only Standard of Care.

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