Ayurveda and Management of COVID-19 in Rural Indian Population: A pilot, double blind, randomized control trial

Author(s):  
K P Bharath Chandra ◽  
Saumya Subramanian ◽  
Rohini Wadhawan ◽  
Akhilesh Mohan Wodeyar ◽  
Alefia Zakir Marfatia ◽  
...  

Abstract Background The SARS-CoV-2 virus responsible for the COVID-19 pandemic is a highly contagious and rapidly mutating virus. The COVID-19 pandemic has affected millions globally over the last 18 months and continues to overwhelm the healthcare system in several countries to date. The healthcare and scientific community has been vigorously searching for ways to manage the disease. Several solutions based on traditional systems of medicine like Ayurveda are also being explored for their effectiveness in managing COVID-19. The study explored the efficacy of a 19 ingredient Ayurvedic polyherbal formulation called NOQ19, on the recovery of mild, RT-PCR positive COVID-19 patients. Methods This was a prospective, double blind, randomized control trial that included 92 patients with a RT-PCR positive mild case of COVID-19. The patients were enrolled from rural areas of Karnataka, a state in India. The patients were randomized between the NF2 and placebo arms, in a 1:1 ratio, and were provided their respective intervention, along with the standard of care treatment (SOC). The trial took place at the Community Care Center, Konnanuru, Hassan, Karnataka. The study duration was around 2 months and the follow-up period for an individual patient was 14 days. RT-PCR analysis was done at baseline, Day 3, 7 and 10. Blood markers to track inflammation were assessed at baseline, Day 3 and 7. Result A statistically significant difference was observed between the two groups with regards to the percentage of population who turned RT-PCR negative on Day 3 and Day 10. On all three assessment time points (Day 3, 7 and 10), the NF2+SOC arm showed a greater percentage of population who were RT-PCR negative compared to the placebo+SOC arm: Day 3 (NF2 -19%, Placebo - 0%) ; Day 7 (NF2- 41%, Placebo - 19%) ; Day 10 (NF2-73%, Placebo 44%). No significant changes were observed in blood markers for both the groups. Conclusion NF2 administered along with standard of care treatment aided early recovery from COVID-19 as demonstrated by a higher percentage of population who were RT-PCR negative on Day 3, 7 and 10. No side effects were observed during the entire study duration. Early recovery of patients is essential for rational usage of limited healthcare resources in a pandemic.

2021 ◽  
Author(s):  
Pankaj Bhardwaja ◽  
Kalaiselvan Ganapathy ◽  
Monika Pathania ◽  
K H Naveen ◽  
Jaykaran Charan ◽  
...  

Abstract BackgroundTraditional medicine systems such as Ayurveda contain a vast repository of naturally occurring herbs with strong antimicrobial potency. A multitude of complementary therapies have been explored for their therapeutic role to treat COVID-19 during the pandemic. There have been promising results reported from in silico, in vitro and in vivo studies that need to be further explored in humans.ObjectiveThe present randomized placebo control trial evaluates the clinical efficacy of an integrated approach including Ayurvedic polyherbal formulation, NOQ19 in the improvement of mild to moderate category of COVID-19 infected patients.Patients and methodsA multicentric, randomized, placebo control design was adopted for the study. A total of 76 patients with positive COVID-19 RT-PCR test were enrolled in the study; 39 in the NOQ19 arm and 37 in the placebo arm. Patients were randomized and blinded to their respective intervention, which was provided along with the standard of care treatment. Rate of recovery assessment was done on Day 3, 5 and 7 via RT-PCR test to measure the rate of recovery. Blood markers were analysed on Day 0 and Day 7.OutcomesThe patients were assessed for rate of recovery via RT-PCR and improvement in blood biomarkers. They were also monitored for any adverse events or side effects of the drug.ResultsThe present study demonstrated a significant early recovery in the patients who took the NOQ19 formulation. Patients who received NOQ19 with the standard care of treatment showed clinical improvement in terms of oxygen requirement, breathlessness and SpO2, though the difference was not statistically significant. Moreover, no side effects were observed with the use of NOQ19.ConclusionAn overall integrated approach of standard of care treatment with Ayurvedic formulation (NOQ19) results in early clinical outcome in the management of mild to moderate cases of COVID-19.


2021 ◽  
Author(s):  
Abhishek Arun ◽  
Amit Gupta ◽  
Saumya Subramanian ◽  
Divya Kanchibhotla

Abstract Introduction: The COVID-19 pandemic is a global health crisis that has affected millions of people worldwide. Apart from measures taken to reduce the transmission of virus and provide symptomatic relief to patients, a potent drug targeted against the virus is required to manage the disease. Traditional medicines with an array of phytochemicals and potent anti-viral properties, can provide alternate solution in the therapeutic cure of COVID-19.Objective: The present study investigates the efficacy of an Ayurvedic formulation, NOQ19, on the rate of recovery and clinical improvement among moderate-severe COVID-19 infected patients who were not on a ventilator or in intensive care unit.Methods: A placebo controlled randomized study design, with 1:1 ratio between the intervention and placebo arms was adopted. The participants were provided their respective intervention along with the standard of care treatment. A follow up was conducted on Day 7 and Day 10 to assess the rate of recovery and clinical improvement. Rate of recovery was the primary outcome measured and was determined by a negative result on the RT-PCR test. The secondary outcomes included clinical improvement among patients and were measured using blood biomarkers.Results: The NOQ19 arm had a higher percentage of population who turned RT-PCR negative on Day 7 (23%) when compared to the placebo arm (11%). Further subgroup analysis demonstrated that for both moderate and severe patients, there were a greater percentage of population who were RT-PCR negative in the NOQ19 arm compared to the placebo arm at Day 7: (NOQ-19: 22.22%, Placebo: 14.29% for moderate patients), (NOQ19: 23.08% Placebo: 0% for severe patients). By Day 10, both populations depicted an almost similar percentage of the population who were RT- PCR negative. Both the groups demonstrated an improvement in blood biomarkers, although the improvement was greater in the NOQ19 arm. None of the patients in the intervention arm reported any adverse events.Conclusion: The results of this pilot RCT indicates that NOQ19 along with standard of care treatment can be considered as an effective therapy for COVID-19 and aid early recovery from the disease.


2021 ◽  
Vol 4 (1) ◽  
pp. 11-7
Author(s):  
Fritzky Indradata ◽  
Heri Dwi Purnomo ◽  
Muh. Husni Thamrin ◽  
Sugeng Budi Santoso ◽  
Ardana Tri Arianto ◽  
...  

Latar Belakang: Anestesi spinal mempunyai efek samping berupa hipotensi dan mual muntah. Tujuan: penelitian ini adalah membandingkan efek anestesi spinal bupivacain dosis normal 12,5 mg dan bupivacain dosis rendah 5 mg dengan fentanyl 50 mg pada seksio sesarea terhadap perubahan hemodinamik, ketinggian blok, onset, durasi dan efek samping. Subjek dan Metode: Penelitian double blind randomized control trial pada 36 pasien yang memenuhi kriteria. Pasien dibagi menjadi dua kelompok, yang masing-masing terdiri 18 pasien, kelompok 1 dilakukan anestesi spinal dengan bupivacain hiperbarik 5 mg ditambah adjuvan fentanyl 50 mcg, sedangkan kelompok 2 diberikan bupivacain hiperbarik 12,5 mg. Penilaian meliputi saat mula kerja blokade sensorik, mula kerja blokade motorik, durasi, tekanan darah, laju nadi, dan saturasi oksigen, lama kerja dan efek samping. Data hasil penelitian diuji secara statistik dengan uji chi-square. Hasil: Terdapat perbedaan signifikan pada onset dan durasi blokade sensorik dan motorik, bupivacain 12,5 mg lebih baik dibandingkan bupivacain 5 mg + fentanyl 50 mcg (p<0.05). Tidak ada perbedaan signifikan pada perubahan tanda vital dan efek samping (p>0.05). Simpulan: Bupivacain 12,5 mg menghasilkan onset lebih cepat dan durasi lebih lama dibandingkan bupivacain 5 mg + fentanil 50 mcg pada anestesi spinal untuk seksio sesarea   Comparison of The Effectiveness Spinal Anesthesia with Bupivacaine 12,5 Mg and Bupivacaine 5 Mg added Fentanyl 50 Mcg in Caesarean Section Abstract Background: Spinal anesthesia has side effects such as hypotension and nausea and vomiting. Objective: The aim of this study was to compare the effects of spinal anesthesia with normal doses of 12,5 mg of bupivacaine and 5 mg of low-dose bupivacaine with fentanyl 50 mg in the cesarean section on hemodynamic changes, block height, onset, duration, and side effects. Subjects and Methods: Double-blind randomized control trial in 36 patients who met the criteria. Patients were divided into two groups, each consisting of 18 patients, group 1 underwent spinal anesthesia with 5 mg of hyperbaric bupivacaine plus 50 mcg of fentanyl adjuvant, while group 2 was given 12,5 mg of hyperbaric bupivacaine. Assessments include the initiation of sensory block action, onset of motor block action, duration, blood pressure, pulse rate, and oxygen saturation, duration of action, and side effects. The research data were statistically tested with the chi-square test. Results: There were significant differences in the onset and duration of sensory and motor blockade, bupivacaine 12,5 mg was better than bupivacaine 5 mg + fentanyl 50 mcg (p <0.05). There was no significant difference in changes in vital signs and side effects (p> 0.05). Conclusion: Bupivacaine 12,5 mg resulted in a faster onset and longer duration than bupivacaine 5 mg + fentanyl 50 mcg in spinal anesthesia for cesarean section.


2021 ◽  
Author(s):  
Divya Kanchibhotla ◽  
Prateek Harsora ◽  
Saumya Subramanian ◽  
Ravi reddy ◽  
Hari Venkatesh

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.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S187-S187
Author(s):  
Matthew P Cheng ◽  
Alexander Lawandi ◽  
Guillaume Butler-Laporte ◽  
Samuel De L’Etoile-Morel ◽  
Katryn Paquette ◽  
...  

Abstract Background Bloodstream infections (BSI) caused by methicillin-susceptible Staphylococcus aureus (MSSA) are associated with significant morbidity and mortality. The objective of our study was to determine whether daptomycin given in combination with an anti-staphylococcal beta-lactam improved outcomes in MSSA BSI. Methods A randomized, double blind, placebo-controlled trial was performed at two academic hospitals in Montreal, Canada. Patients ≥ 18 years of age with MSSA BSI receiving either cefazolin or cloxacillin monotherapy were considered for inclusion. In addition to the standard of care treatment, participants received a 5-day course of adjunctive daptomycin or placebo. The primary outcome was the duration of MSSA BSI in days. Results Of 318 participants screened, 115 were enrolled and 104 were included in the intention to treat analysis (median age 67 years; 34.5% female). The median duration of bacteremia was 2.04 days among patients who received daptomycin versus 1.65 days in those who received placebo (absolute difference 0.39 days, p=0.40). A modified intention to treat analysis involving participants who remained bacteremic at the time of enrollment found a median duration of bacteremia of 3.06 days among patients who received daptomycin versus 3.0 days in those who received placebo (absolute difference 0.06 days, p=0.77). Ninety-day mortality in the daptomycin arm was 18.9% vs. 17.7% in the placebo arm (p=1.0). There were no significant differences in the proportion of patients who developed renal failure, hepatotoxicity, or rhabdomyolysis between groups. Conclusion Among patients with MSSA BSI, the administration of adjunctive daptomycin therapy to standard of care treatment did not shorten the duration of bacteremia. Disclosures All Authors: No reported disclosures


2021 ◽  
Author(s):  
Divya Kanchibhotla ◽  
Prateek Harsora ◽  
Saumya Subramanian ◽  
Ravi reddy ◽  
Hari Venkatesh

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.


2021 ◽  
Author(s):  
Divya Kanchibhotla ◽  
Prateek Harsora ◽  
Saumya Subramanian ◽  
Ravi reddy ◽  
Hari Venkatesh

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.


2020 ◽  
Vol 1 (1) ◽  
pp. 1-8
Author(s):  
Adi Hidayat ◽  
Yusmein Uyun ◽  
Sri Rahardjo

Latar Belakang: Shivering perioperatif selama anestesi spinal merupakan komplikasi yang sering terjadi seksio sesarea karena vasodilatasi perifer akibat blok simpatis dan irigasi cairan dingin. Meningkatnya tonus otot yang tampak sebagai shivering akan meningkatkan kebutuhan oksigen antara 200-800% dan produksi karbondioksida meningkat antara 300-500% diatas nilai dasarnya. Hal ini akan dapat berbahaya bagi pasien dengan kondisi fisik tidak optimal. Karena itu shivering harus segera dicegah atau diatasi.Tujuan: Mengetahui perbandingan kejadian shivering antara pemberian cairan ringer laktat 1000 cc suhu 40° C dengan Ringer laktat 1000 cc dengan suhu kamar pada operasi seksio sesarea yang dilakukan spinal anestesi.Metode:Subjek penelitian ini sebanyak 102 pasien yang memenuhi kriteria inklusi dan dilakukan secara double blind randomized control trial. Sebelum dilakukan spinal anestesi, kelompok A diberikan pemberian ringer laktat 1000 cc dengan menggunakan penghangat infus 3 lumen pada suhu 40° C, kelompok B diberikan pemberian ringer laktat 1000 cc pada suhu kamar. Dilakukan pengukuran suhu tubuh setelah dilakukan pemberian cairan dan dinilai adanya shivering atau tidak di ruang pemulihan. Hasil: Didapatkan kejadian shivering pada kelompok A yaitu sebanyak 2 pasien (3,9 %) dan kejadian shivering pada kelompok B yaitu sebanyak 8 pasien (15,7 %). Di dapatkan perbedaan yang bermakna antara kedua kelompok (P <0,05). Kesimpulan: Terdapat perbedaan bermakna kejadian shivering pada kelompok yang diberikan ringer laktat 1000 cc dengan suhu40° C dibandingkankelompok yang diberikan ringer laktat 1000 cc pada suhu kamar. The Comparison of Ringer’s Lactate 40 °C and Ringer's Laktat at Room Temperature To Prevent Shivering in Cesarean Section with Spinal Anesthesia Background: Perioperative shivering during spinal anesthesia is a common complication in cesarean surgery caused by peripheral vasodilatation due to sympathetic block and fluid cold irrigation. Increased muscle tone which seemed as shivering will increase 200-800% oxygen requirement and carbon dioxide production increased of 300-500% above the baseline. This will be dangerous for patients with not optimal physical condition. Therefore, shivering should be prevented immediately.Objective: To comparing shivering incident between 1000 cc ringer's lactate administration at 40 ° C and 1000 cc ringer's lactate administration at room temperature in cesarean surgery with spinal anesthesia. .Methods: The study subject was 102 patients who met the inclusion criteria and conducted a double-blind randomized control trial. Before spinal anesthesia, group A was given 1000 cc ringer's lactate at 40 ° C, group B was given 1000 cc ringer's lactate at room temperature. After fluid administration the body temperature was measured and shivering was assessed in the recovery room.Results: The shivering incidence in group A of 2 patients (3.9%) and the shivering incidence in group B of 8 patients (15.7%). There was a significant difference between the two groups (P <0.05).Conclusions: There are significant differences in the incidence of shivering in the 1000 cc ringer's lactate at 40°C administration group compared to the room temperature group.


Cancers ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 952
Author(s):  
Lucy Dumas ◽  
Rebecca Bowen ◽  
John Butler ◽  
Susana Banerjee

Older women with ovarian cancer have disproportionately poorer survival outcomes than their younger counterparts and receive less treatment. In order to understand where the gaps lie in the treatment of older patients, studies incorporating more detailed assessment of baseline characteristics and treatment delivery beyond the scope of most cancer registries are required. We aimed to assess the proportion of women over the age of 65 who are offered and receive standard of care for first-line ovarian cancer at two UK NHS Cancer Centres over a 5-year period (December 2009 to August 2015). Standard of care treatment was defined as a combination of cytoreductive surgery and if indicated platinum-based chemotherapy (combination or single-agent). Sixty-five percent of patients aged 65 and above received standard of care treatment. Increasing age was associated with lower rates of receiving standard of care (35% > 80 years old versus 78% of 65–69-year-olds, p = 0.000). Older women were less likely to complete the planned chemotherapy course (p = 0.034). The oldest women continue to receive lower rates of standard care compared to younger women. Once adjusted for Federation of Gynaecology and Obstetrics (FIGO) stage, Eastern Cooperative Oncology Group (ECOG) performance status and first-line treatment received, age was no longer an independent risk factor for poorer overall survival. Optimisation of vulnerable patients utilising a comprehensive geriatric assessment and directed interventions to facilitate the delivery of standard of care treatment could help narrow the survival discrepancy between the oldest patients and their younger counterparts.


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