scholarly journals Efficacy of a polyherbal formulation in the treatment of SARS CoV-2 disease: An open labelled feasibility study

2021 ◽  
Author(s):  
Divya Kanchibhotla ◽  
Prateek Harsora ◽  
Saumya Subramanian ◽  
Ravi reddy ◽  
Hari Venkatesh
Keyword(s):  
Standard Care ◽  
Rt Pcr ◽  
Open Label ◽  
Safe Alternative ◽  
Subjective Analysis ◽  
Adjunct Treatment ◽  
Polyherbal Formulation ◽  
Symptomatic Management ◽  
Approved Drugs ◽  
Time Required

Abstract Background: The ongoing pandemic caused by human coronavirus SARS CoV-2 has led to millions of death across the globe. Not only the virus is highly infectious, it is also mutates very easily. Currently there are no approved drugs for the therapeutic cure of COVID-19. The world is in search for an alternative that has antiviral properties directed against virus. Objective: The present study investigates an Ayurvedic polyherbal formulation of 13 herbs, named NOQ19, targeted against various viral proteins of COVID-19. Methodology: The study is a single arm, single centric, open label study of 161 RT-PCR positive COVID-19 patients. The enrolled participants were given the ayurvedic intervention, 2 tablets, thrice daily, to be consumed along with the standard care. Follow up COVID-19 RT- PCR was done on Day 5, Day 10 and Day 14 or until the patient turned negative. The time required for turning RT-PCR negative or become asymptomatic was noted. Results: Subjective analysis demonstrated that 98% of patients turned asymptomatic within 5 days of NOQ19 intake. Also 74% of the subjects turned RT-PCR Negative on Day 5 after taking NOQ19 along with the standard care provided. Also, none of the participant reported any adverse effect or side effect to the medication.Conclusion: NOQ19 Ayurvedic polyherbal formulation is an effective as well as safe alternative and adjunct treatment for the symptomatic management of COVID-19.

scholarly journals Rate of Recovery and Symptomatic Efficacy of a Polyherbal AYUSH Formulation in the Treatment of SARS CoV-2 disease: A Single-arm trial

2021 ◽  
Author(s):  
Divya Kanchibhotla ◽  
Prateek Harsora ◽  
Saumya Subramanian ◽  
Ravi reddy ◽  
Hari Venkatesh
Keyword(s):  
Standard Of Care ◽  
Rt Pcr ◽  
Open Label ◽  
Subjective Analysis ◽  
Polyherbal Formulation ◽  
Care Treatment ◽  
Symptomatic Management ◽  
Standard Of Care Treatment ◽  
Rate Of Recovery ◽  
Time Required

Abstract Background: The COVID-19 pandemic, caused by the human coronavirus SARS CoV-2, has led to millions of deaths across the globe. Not only is the SARS CoV-2 virus highly infectious, it also mutates very easily. This creates additional challenges for development of robust therapeutic solutions. Along with modern system of healthcare, there is a definite need for exploring natural plant based antiviral compounds directed against the SARS CoV-2 virus. Objective: The present observational study investigates the efficacy of an Ayurvedic polyherbal formulation of 19 ingredients, NOQ19, in the management of COVID-19. Methodology: A single arm, single centric, open label study design was adopted for this feasibility study. 161 RT-PCR positive COVID-19 patients were enrolled. The enrolled participants were provided the Ayurvedic intervention, 2 tablets of NOQ19, thrice daily along with the standard of care treatment. Follow up COVID-19 RT- PCR tests were conducted on Day 5, Day 10 and Day 14, or until the patient turned negative. The time required for testing negative on the RT-PCR test or becoming asymptomatic was noted. Results: A subjective analysis demonstrated that 74% of patients turned RT-PCR negative within 5 days of taking NOQ19. Additionally, 98% of the subjects turned RT-PCR Negative on Day 10 after taking NOQ19 in addition to the standard of care treatment of Vitamin C , Zinc and antipyretic (as necessary). None of the participants reported any adverse or side effects to the medication.Conclusion: NOQ19 Ayurvedic polyherbal formulation can be an effective and safe option for the symptomatic management of COVID-19.

scholarly journals Rate of Recovery and Symptomatic Efficacy of a Polyherbal AYUSH Formulation in the Treatment of SARS CoV-2 disease: A Single-arm trial

2021 ◽  
Author(s):  
Divya Kanchibhotla ◽  
Prateek Harsora ◽  
Saumya Subramanian ◽  
Ravi reddy ◽  
Hari Venkatesh
Keyword(s):  
Standard Of Care ◽  
Rt Pcr ◽  
Open Label ◽  
Subjective Analysis ◽  
Polyherbal Formulation ◽  
Care Treatment ◽  
Symptomatic Management ◽  
Standard Of Care Treatment ◽  
Rate Of Recovery ◽  
Time Required

Abstract Background The COVID-19 pandemic, caused by the human coronavirus SARS CoV-2, has led to millions of deaths across the globe. Not only is the SARS CoV-2 virus highly infectious, it also mutates very easily. This creates additional challenges for development of robust therapeutic solutions. Along with modern system of healthcare, there is a definite need for exploring natural plant based antiviral compounds directed against the SARS CoV-2 virus. Objective The present observational study investigates the efficacy of an Ayurvedic polyherbal formulation of 19 ingredients, NOQ19, in the management of COVID-19. Methodology: A single arm, single centric, open label study design was adopted for this feasibility study. 161 RT-PCR positive COVID-19 patients were enrolled. The enrolled participants were provided the Ayurvedic intervention, 2 tablets of NOQ19, thrice daily along with the standard of care treatment. Follow up COVID-19 RT- PCR tests were conducted on Day 5, Day 10 and Day 14, or until the patient turned negative. The time required for testing negative on the RT-PCR test or becoming asymptomatic was noted. Results A subjective analysis demonstrated that 74% of patients turned RT-PCR negative within 5 days of taking NOQ19. Additionally, 98% of the subjects turned RT-PCR Negative on Day 10 after taking NOQ19 in addition to the standard of care treatment of Vitamin C, Zinc and antipyretic (as necessary). None of the participants reported any adverse or side effects to the medication. Conclusion NOQ19 Ayurvedic polyherbal formulation can be an effective and safe option for the symptomatic management of COVID-19.

scholarly journals Rate of Recovery and Symptomatic Efficacy of a Polyherbal AYUSH Formulation in the Treatment of SARS CoV-2 disease: A Single-arm trial

2021 ◽  
Author(s):  
Divya Kanchibhotla ◽  
Prateek Harsora ◽  
Saumya Subramanian ◽  
Ravi reddy ◽  
Hari Venkatesh
Keyword(s):  
Standard Of Care ◽  
Rt Pcr ◽  
Open Label ◽  
Subjective Analysis ◽  
Polyherbal Formulation ◽  
Care Treatment ◽  
Symptomatic Management ◽  
Standard Of Care Treatment ◽  
Rate Of Recovery ◽  
Time Required

Abstract Background The COVID-19 pandemic, caused by the human coronavirus SARS- CoV-2, has led to millions of deaths across the globe. Not only is the SARS-CoV-2 virus highly infectious, it also mutates very easily. This creates additional challenges for development of robust therapeutic solutions. Along with modern system of healthcare, there is a definite need for exploring natural plant based antiviral compounds directed against the SARS CoV-2 virus. Objective The present observational study investigates the efficacy of an Ayurvedic polyherbal formulation of 19 ingredients, NOQ19, in the management of COVID-19. Methodology: A single arm, single centric, open label study design was adopted for this feasibility study. 161 RT-PCR positive COVID-19 patients were enrolled. The enrolled participants were provided the Ayurvedic intervention, 2 tablets of NOQ19, thrice daily along with the standard of care treatment. Follow up COVID-19 RT- PCR tests were conducted on Day 5, Day 10 and Day 14, or until the patient turned negative. The time required for testing negative on the RT-PCR test or becoming asymptomatic was noted. Results A subjective analysis demonstrated that 74% of patients turned RT-PCR negative within 5 days of taking NOQ19. Additionally, 98% of the subjects turned RT-PCR Negative on Day 10 after taking NOQ19 in addition to the standard of care treatment of Vitamin C, Zinc and antipyretic (as necessary). None of the participants reported any adverse or side effects to the medication. Conclusion NOQ19 Ayurvedic polyherbal formulation can be an effective and safe option for the symptomatic management of COVID-19.

scholarly journals Outcome of ivermectin treated mild to moderate COVID-19 cases: a single-centre, open-label, randomised controlled study

2021 ◽  
Vol 14 (2) ◽  
pp. 11-18
Author(s):  
Chinmay Saha Podder ◽  
Nandini Chowdhury ◽  
Mohim Ibne Sina ◽  
Wasim Md Mohosin Ul Haque
Keyword(s):  
Usual Care ◽  
Recovery Time ◽  
Early Stage ◽  
Controlled Study ◽  
Rt Pcr ◽  
Open Label ◽  
Total Recovery ◽  
Randomised Controlled Study ◽  
Time Required ◽  
Randomised Controlled

Background and objectives: Various existing non-antiviral drugs are being used to treat severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection based mostly on existing data from previous coronavirus outbreaks. Ivermectin is one of such agents being widely used to treat early-stage of COVID-19. This study evaluated the outcome of ivermectin treated mild to moderate COVID-19 cases compared to usual care. Methods: This open-label randomised controlled study was conducted at a sub-district (Upazila) health complex from 1st May 2020 to the end of July 2020. Consecutive RT-PCR positive eligible COVID-19 patients were randomised into control and intervention arms. In the intervention arm, ivermectin 200 micrograms/kg single dose was administered orally in addition to usual care and was followed up till recovery. Repeat RT-PCR was done on day ten since the first positive result. The end point with regard to treatment outcome was time required for the resolution of symptoms from the onset of the symptoms and following enrollement in the study. Results: A total of 62 mild to moderate COVID-19 patients were enrolled in the study. There were 30 patients in the control arm and 32 patients in the intervention arm. Total recovery time from the onset of symptoms to complete resolution of symptoms of the patients in the intervention arm was 10.09 ± 3.236 days, compared to 11.50 ± 5.32 days in the control arm (95% CI -0.860,3.627, p>. 05) and was not significantly different. The mean recovery time after enrolment in the intervention arm was 5.31 ± 2.48 days, which also did not differ significantly from the control arm of 6.33 ± 4.23 days (95% CI – 0.766, 2.808, p> 0.05). Results of negative repeat RT- PCR were not significantly different between control and intervention arms (control 90% vs intervention 95%, p>.05). Conclusion: Ivermectin had no beneficial effect on the disease course over usual care in mild to moderate COVID-19 cases. Ibrahim Med. Coll. J. 2020; 14(2): 11-18

scholarly journals AYUSH-64 as an adjunct to Standard Care in mild to moderate COVID-19: An open-label randomized controlled trial in Chandigarh, India

2021 ◽  
Author(s):  
Harbans Singh ◽  
Sumit Shrivastva ◽  
Babita Yadav ◽  
Amit Kumar Rai ◽  
Sophia Jameela ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Inflammatory Markers ◽  
Standard Care ◽  
Controlled Trial ◽  
Control Group ◽  
Rt Pcr ◽  
Open Label ◽  
Clinical Recovery ◽  
Randomized Controlled ◽  
Significant Difference

Background: There is limited evidence on the safety and efficacy of administering Ayurveda interventions as add-on to the standard care for COVID-19. Objective: To explore the therapeutic efficacy and safety of AYUSH-64 as an add-on to standard care in the management of mild to moderate stage COVID-19.Design, setting, participants and interventions: This was an open-label randomized controlled trial with 80 patients of mild to moderate stage COVID-19. Participants in the AYUSH-64 add-on group received two tablets (500 mg each) three times daily for 30 days along with conventional standard care (Paracetamol, Cetirizine, Vitamin C, and Azithromycin). The control group received standard care alone. Main outcome measures: The primary outcome assessed was the proportion of participants with clinical recovery and negative RT-PCR assay for COVID-19 on day 7, 15, 23, and 30. Additionally, change in pro-inflammatory markers, metabolic functions, HRCT chest and incidence of Adverse Drug Reaction (ADR) / Serious Adverse Event (SAE) were assessed.Results: Statistically significant difference was observed in the proportion of participants with clinical recovery in the AYUSH-64 add-on group (p<0.001) at each of the scheduled follow-up visits. All the participants in the AYUSH-64 add-on group clinically recovered by day 23 compared to 32.4 per cent in the control group. The mean duration for clinical recovery in AYUSH-64 add-on group (5.8 ± 2.67 days) was less as compared to control group (10.0 ± 4.06 days). The proportion of participants who turned RT-PCR negative for COVID-19 on day 7, 15, and 23 were 81.8, 94.5, and 100 per cent in AYUSH-64 add-on group, and 79.4, 94.5, and 97.2 per cent in control group, however, the difference observed was statistically not significant (p=0.314). The proportion of participants with improvement in HRCT chest was statistically significant in AYUSH-64 add-on group (p=0.031) unlike in control group (p=0.210). Similar reductions in most inflammatory markers measured (IL-6, CRP, Serum ferritin, and LDH) on day 30 (p<0.05) were observed in both groups. Conclusion: AYUSH-64 as adjunct to standard conventional care is safe and hastens clinical recovery in adult patients with mild to moderate COVID-19.

Virtual screening of potential therapeutic inhibitors against spike, helicase and polymerase of SARS-CoV-2 (COVID-19)

Coronaviruses ◽  
2020 ◽  
Vol 01 ◽  
Author(s):  
Ayesha Tazeen ◽  
Farah Deeba ◽  
Aftab Alam ◽  
Rafat Ali ◽  
Romana Ishrat ◽  
...  
Keyword(s):  
Catalytic Domain ◽  
Nigella Sativa ◽  
Therapeutic Option ◽  
Natural Compounds ◽  
Host Cells ◽  
Nucleoside Triphosphate ◽  
Symptomatic Management ◽  
Replication Inhibitor ◽  
Inhibitory Potential ◽  
Approved Drugs

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected around 13 million people and has caused more than 5.7 lakh deaths worldwide since December 2019. In the absence of FDA approved drug for its treatment, only symptomatic management is done. Methods: We attempted to uncover potential therapeutic targets of spike, helicase and RNA dependent RNA polymerase (RdRp) proteins of the SARS-CoV-2 employing computational approach. The PDB structure of spike and RdRp and predicted structure of helicase proteins were docked with 100 approved antiviral drugs, natural compounds and some other chemical compounds. Results: The anti-SARS ligands EK1 and CID_23631927, and NCGC00029283 are potential entry inhibitor as it showed affinity with immunogenic receptor binding domain (RBD) of spike protein. This RBD interacts with angiotensin converting enzyme (ACE2) receptor facilitating the entry of virion in the host cells. The FDA approved drugs including Nelfinavir, Saquinavir, Tipranavir, Setrobuvir, Indinavir and Atazanavir showed potential inhibitory activity against targeted domains and thus may act as entry or replication inhibitor or both. Furthermore, several anti-HCoV natural compounds including Amentoflavone, Rutin and Tannin are also potential entry and replication inhibitor as they showed affinity with RBD, Ploop containing nucleoside triphosphate hydrolase and catalytic domain of the respective protein. Dithymoquinone showed significant inhibitory potential against the fusion peptide of S2 domain. Importantly, Tannin, Dithymoquinone and Rutin can be extracted from Nigella sativa seeds and thus may prove to be one of the most potential anti-SARS-CoV-2 inhibitor. Conclusion: Several potential ligands were identified with already known anti-HCoVs activities. Furthermore, as our study showed that some of the ligands acted as both entry or replication inhibitor against SARS-CoV-2, it is envisaged that a combination of either inhibitors with a dual mode of action would prove to be a much desired therapeutic option against this viral infection.

Evaluating Thrombin Inhibition in Alzheimer’s Disease (The BEACON Trial): Protocol for a Pilot Study (Preprint)

2019 ◽  
Author(s):  
Cláudia Yang Santos ◽  
Christine Getter ◽  
John Stoukides ◽  
Brian Ott ◽  
Stephen Salloway ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Pilot Study ◽  
Cognitive Performance ◽  
Thrombin Inhibitor ◽  
Placebo Control ◽  
Open Label ◽  
Double Blind ◽  
Thrombin Inhibition ◽  
Approved Drugs

BACKGROUND The precise mechanisms whereby cardiovascular risk factors increase the risk of Alzheimer’s disease (AD) have not been delineated. We reported that microvessels isolated from AD brains overexpress a diverse array of neurotoxic and inflammatory proteins, which is consistent with the process of vascular activation. In pre-clinical studies using AD animal models we showed that a vascular activation inhibitor reduced vascular-derived neuroinflammation and improved cognitive performance. Thrombin is a key mediator of cerebrovascular activation in AD. OBJECTIVE This study aims to investigate the safety and potential efficacy of the direct thrombin inhibitor dabigatran, in patients with mild cognitive impairment (MCI) or mild AD to decrease vascular-derived neuroinflammation and improve cognitive performance. METHODS Participants will be enrolled then evaluated quarterly throughout the 24-month study. This is a 24-month randomized-control, double-blind, placebo-controlled, multicenter, delayed-start, pilot study evaluating thrombin inhibition in people with biomarker-confirmed MCI probably due to AD or mild AD. 40 - 60 participants will be recruited between 50 - 85 years old. In the initial 9-months of study, either dabigatran or placebo will be orally administered to patients at a dose of 150 mg per day. After 9 months of the placebo-control (Phase I), the placebo arm will cross-over to an active, open-label (Phase II) where all patients will be treated with a 150 mg daily dose of dabigatran orally for an additional 12 months. A 3-month non-treatment follow-up period will assess duration of effects. RESULTS Beginning in July 2019, and concluding in August 2022, this study is expected to publish final results in January 2023. CONCLUSIONS BEACON is a first-in-kind randomized clinical trial targeting thrombin activation in AD therapeutics. This trial will stimulate translational investigations of an FDA-approved drugs in a newly defined therapeutic areas. CLINICALTRIAL Clinicaltrials.gov NCT03752294

scholarly journals Azithromycin versus standard care in patients with mild-to-moderate COVID-19 (ATOMIC2): an open-label, randomised trial

2021 ◽  
Author(s):  
Timothy S C Hinks ◽  
Lucy Cureton ◽  
Ruth Knight ◽  
Ariel Wang ◽  
Jennifer L Cane ◽  
...  
Keyword(s):  
Standard Care ◽  
Randomised Trial ◽  
Open Label
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