scholarly journals A prospective, open label, randomized-controlled study to evaluate the efficacy and safety of Herbovir syrup in mildly symptomatic COVID-19 patients

2020 ◽  
Vol 10 (1) ◽  
pp. 106
Author(s):  
A. Gopal Rao ◽  
Shankar Achar Somashekar ◽  
Poorna Prasad ◽  
Manjunath Reddy Lekkala ◽  
Sreenivasa Hanumanthaiah ◽  
...  
Keyword(s):  
Clinical Symptoms ◽  
Standard Of Care ◽  
Pulmonary Complications ◽  
Controlled Study ◽  
Control Group ◽  
P Value ◽  
Immune Markers ◽  
Open Label ◽  
Early Recovery ◽  
D Dimer

Background: COVID-19 patients experience cytokine storm which cause pulmonary and extra-pulmonary complications. Effective antiviral and immune boosters are need of hour to treat COVID-19 as well as post COVID complications.Methods: In this study involving mild COVID-19 we randomized 40 patients to receive a Herbovir syrup along with standard of care (SOC) or SOC alone in 1:1 ratio. We evaluated the benefits of Herbovir syrup by assessing clinical outcomes and improvement in immune markers (LDH, CRP, D-dimer).Results: At the end of the study the immune markers in Herbovir group improved significant compared to control group. In patients who received Herbovir, LDH decreased from 334 U/l at baseline to 254 U/l at the end of treatment (p value <0.009), CRP decreased from 7.4 mg/l to 3.1 mg/l (p value=0.0171) and D-dimer decreased from 0.610 mg/l at baseline to 318 mg/l at the end of study (p value=0.001). TLC values did not go below normal range in Herbovir group whereas 8 patients in control group had low TLC at the end of study. Early recovery from COVID 19 symptoms was observed in >75% patients in Herbovir treated group.Conclusions: Herbovir accelerated recovery of COVID-19 patients by early improvement in clinical symptoms and immune markers in this study and results clearly indicates that Herbovir syrup has antiviral, immune booster activity and has definitive role in the management of mild COVID-19 patients along with standard of care. (Funded by Venkat pharma. CTRI no. CTRI/2020/08/027041).

scholarly journals A prospective, open label, randomized-controlled study to evaluate the efficacy and safety of MyVir tablets in mildly symptomatic COVID-19 patients

2021 ◽  
Vol 10 (8) ◽  
pp. 967
Author(s):  
C. R. Jayanthi ◽  
Shankar A. S. ◽  
M. Ravi Shankar ◽  
Lakshmana Perumal S. P. T. ◽  
Manjunath Reddy L. ◽  
...  
Keyword(s):  
Clinical Symptoms ◽  
Test Group ◽  
Standard Of Care ◽  
Controlled Study ◽  
Control Group ◽  
Immune Markers ◽  
Open Label ◽  
Early Recovery ◽  
Early Improvement ◽  
D Dimer

Background: Coronavirus can cause pneumonia, respiratory failure and death. The emergence of novel coronavirus has posed a challenging situation that warrants urgent global attention. Currently there was no effective therapy available for COVID-19 and hence antiviral and immune modulators are most sought after medicines to manage complications of COVID-19.Methods: In this study involving mild COVID-19 we randomized 42 patients to receive a MyVir tablets twice daily along with standard of care (SOC) or SOC alone in 1:1 ratio for 14 days. We evaluated the benefits of MyVir tablets by assessing clinical outcomes and improvement in immune markers (LDH, CRP, D-dimer, TLC).Results: At the end of the study the immune markers in MyVir group improved significantly compared to control group. In patients who received MyVir, CRP decreased from 3.3 mg/l to 1.7 mg/l (p=0.0171). D-dimer decreased from 0.589 on day 0 to 0.368 on day 14 (p=0.03) and LDH decreased from 224 U/l on day 0 to 158 U/l on day 14 in test group (p=0.05). TLC showed favorable improvement in study group compared to control group. Early recovery from COVID-19 symptoms was observed in patients on MyVir treated group. Patients treated with MyVir tablets reduced the duration of hospitalization when given along with standard of care.Conclusions: MyVir accelerated recovery of COVID-19 patients by early improvement in clinical symptoms and immune markers in this study and results clearly indicates that MyVir tablets has antiviral, immune booster activity. Hence this study provides evidence that MyVir has definitive role in the management of mild COVID-19 patients along with standard of care (funded by Mi Lab Life Sciences(P) Ltd. CTRI no. CTRI/2020/05/024967).

scholarly journals A prospective, open label clinical study to evaluate the safety, efficacy and tolerability of azadvir herbal steam inhaler in asymptomatic, mildly symptomatic COVID-19 patients and health care workers posted to covid wards

2021 ◽  
Vol 10 (4) ◽  
pp. 373
Author(s):  
Ajitha Pottirayil ◽  
Shankar A. S. ◽  
Shaji Kannoth ◽  
Poorna Prasad ◽  
Sharath Kumar B. Jaikar ◽  
...  
Keyword(s):  
Clinical Symptoms ◽  
Standard Of Care ◽  
P Value ◽  
Rt Pcr ◽  
Immune Markers ◽  
Open Label ◽  
Asymptomatic Group ◽  
Asymptomatic Patients ◽  
Study Results ◽  
D Dimer

Background: COVID-19 patients experience cytokine storm which cause pulmonary and extra-pulmonary complications even with currently available of standard of care. Additional antiviral and immune boosters are the need of hour to treat COVID-19 and to prevent post covid complications.Methods: In this study we enrolled 40 asymptomatic to mild COVID-19 patients to receive azadvir herbal steam inhaler along with standard of care. We evaluated the benefits of azadvir herbal steam inhaler by assessing RT-PCR conversion, clinical outcomes and improvement in immune markers (LDH, CRP, D-DIMER).Results: At the end of the study the immune markers improved significantly in study patients. In mild symptomatic cases IL-6 was 23.2 pg/ml on day 0 and 21.8 pg/ml on day 14. Reduction in IL-6 in mild symptomatic patients was statistically highly significant (p=0.0056). Mean IL-6 in asymptomatic patients was 22.3 pg/ml on day 0 and 21.1 pg/ml on day 14. Reduction in IL-6 in asymptomatic patients was statistically highly significant (p=0.0035).  Mean D-dimer was showing decreasing trend from day 0 to day 14 in mild symptomatic patients. In asymptomatic patients D dimer was 0.8 µg/ml on day 0 and 0.6 µg/ml on day 14. D-dimer decreased significantly from day 0 to day 14 (p value =0.0013). Mean LDH values on day 0 in mild symptomatic patients was 319.4 U/l and 219.3 on day 14. The reduction in LDH values in mild symptomatic patients is statistically significant (p value <0.0122). In asymptomatic patients mean LDH values on day 0 was 237 U/l and 194 U/l on day 14. The reduction in LDH values in asymptomatic group was statistically significant. Mean CRP values in mild symptomatic patients on day 0 was 12.2 mg/l and 3.8 mg/l on day 14. There was significant reduction in CRP values in mild symptomatic group which was statistically significant (p value =0.0546). Mean CRP values in asymptomatic patients on day 0 was 4.9 mg/l and 2.8 mg/l on day 14. There was significant reduction in mean CRP in asymptomatic patients which was statistically significant (p value =0.0446). In the present study all 40 patients (100%) cleared the virus and became negative for RT PCR test within 6 days. None of the patients progressed to severe COVID-19 and none of the patients succumbed to the disease.Conclusions: Azadvir accelerated recovery of COVID-19 patients by RT-PCR conversion, early improvement in clinical symptoms and immune markers in this study. This study results clearly indicates that azadvir has antiviral, immune booster activity and has definitive role in the management of asymptomatic to mild COVID-19 patients along with standard of care (CTRI no. CTRI/2020/06/026181).

scholarly journals Early high antibody-titre convalescent plasma for hospitalised COVID-19 patients: DAWn-plasma

2021 ◽  
pp. 2101724 ◽  
Author(s):  
Timothy Devos ◽  
Quentin Van Thillo ◽  
Veerle Compernolle ◽  
Tomé Najdovski ◽  
Marta Romano ◽  
...  
Keyword(s):  
Clinical Status ◽  
Intervention Group ◽  
Standard Of Care ◽  
Control Group ◽  
P Value ◽  
Open Label ◽  
Care Intervention ◽  
Antibody Titres ◽  
Median Volume ◽  
High Antibody Titre

BackgroundSeveral randomised clinical trials have studied convalescent plasma (CP) for COVID-19 using different protocols, with different SARS-CoV-2 neutralising-antibody-titres, at different time-points and severities of illness.MethodsIn the prospective multicentre DAWN-plasma trial, adult patients hospitalised with COVID-19 were randomised to 4 units of open-label convalescent plasma combined with standard of care (intervention group) or standard of care alone (control group). Plasma from donors with neutralising-antibody-titres (NT50) ≥1/320 was the product of choice for the study.ResultsBetween May 2nd, 2020 and January 26th, 2021, 320 patients were randomised to convalescent plasma and 163 patients to the control group according to a 2:1 allocation scheme. A median volume of 884 mL convalescent plasma (IQR 806–906 mL) was administered, and 80.68% of the units came from donors with neutralising-antibody-titres (NT50) ≥1/320. Median time from onset of symptoms to randomisation was 7 days. The proportion of patients alive and free of mechanical ventilation on Day 15 was not different between both groups (convalescent plasma: 83.74% (n=267) versus control: 84.05% (n=137) – Odds ratio 0.99 (0.59–1.66) – p-value=0.9772). The intervention did not change the natural course of antibody titres. The number of serious or severe adverse events was similar in both study arms, and transfusion-related side effects were reported in 19/320 patients in the intervention group (5.94%).ConclusionsTransfusion of 4 units of convalescent plasma with high neutralising-antibody-titres early in hospitalised COVID-19 patients did not result in a significant improvement of the clinical status, or a reduced mortality.

Postoperative analgesia by adding acupuncture to conventional therapy, a non-randomized controlled trial

2018 ◽  
Vol 16 (2) ◽  
Author(s):  
Ilana Levy ◽  
Samuel Attias ◽  
Lior Cohen ◽  
Nadav Stoppelmann ◽  
Dan Steinberger ◽  
...  
Keyword(s):  
Side Effects ◽  
Postoperative Pain ◽  
Analgesic Effect ◽  
Pain Treatment ◽  
Standard Of Care ◽  
Acupuncture Group ◽  
Controlled Study ◽  
Control Group ◽  
Pain Level ◽  
Randomized Controlled

Abstract Background Postoperative pain is common in patients hospitalized in surgical departments, yet it is currently not sufficiently controlled by analgesics. Acupuncture, a complementary medical practice, has been evaluated for its benefits in postoperative pain with heterogeneous results. We tested the feasibility of a controlled study comparing the postoperative analgesic effect of acupuncture together with standard-of-care to standard-of-care only. Methods In this pilot non-randomized controlled study conducted at a tertiary medical center in Israel, patients received either acupuncture with standard-of-care pain treatment (acupuncture group) or standard-of-care treatment only (control group) following surgery. Visual Analogue Scale (VAS) ratings for pain level at rest and in motion were evaluated both at recruitment and two hours after treatment. Acupuncture-related side effects were reported as well. Results We recruited 425 patients; 336 were assigned to the acupuncture group and 89 to the control group. The acupuncture group exhibited a decrease of at least 40% in average level of pain both at rest (1.8±2.4, p<0.0001) and in motion (2.1±2.8, p<0.0001) following acupuncture, whereas the control group exhibited no significant decrease (p=0.92 at rest, p=0.98 in motion). Acupuncture's analgesic effect was even more prominent in reducing moderate to severe pain at baseline (VAS ≥4), with a decrease of 49% and 45% of pain level at rest and in motion respectively (p<0.001), compared with no significant amelioration in the control group (p=0.20 at rest, p=0.12 in motion). No major side effects were reported. Conclusion Integrating acupuncture with standard care may improve pain control in the postoperative setting.

scholarly journals Effect of conversion from calcineurin inhibitors to everolimus on hepatitis C viremia in adult kidney transplant recipients

2018 ◽  
Vol 40 (2) ◽  
pp. 143-150 ◽  
Author(s):  
Larissa Sgaria Pacheco ◽  
Valter Duro Garcia ◽  
Ronivan Luis Dal Prá ◽  
Bruna Doleys Cardoso ◽  
Mariana Ferras Rodrigues ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Controlled Trial ◽  
Calcineurin Inhibitors ◽  
Control Group ◽  
P Value ◽  
Kidney Transplant Recipients ◽  
Positive Serology ◽  
Open Label ◽  
Adult Kidney ◽  
Group 1

ABSTRACT Introduction: Currently, there is no specific immunosuppressive protocol for hepatitis C (HCV)-positive renal transplants recipients. Thus, the aim of this study was to evaluate the conversion effect to everolimus (EVR) on HCV in adult kidney recipients. Method: This is an exploratory single-center, prospective, randomized, open label controlled trial with renal allograft recipients with HCV-positive serology. Participants were randomized for conversion to EVR or maintenance of calcineurin inhibitors. Results: Thirty patients were randomized and 28 were followed-up for 12 months (conversion group, Group 1 =15 and control group, Group 2 =13). RT-PCR HCV levels reported in log values were comparable in both groups and among patients in the same group. The statistical analysis showed no interaction effect between time and group (p value G*M= 0.852), overtime intra-groups (p-value M=0.889) and between group (p-value G=0.286). Group 1 showed a higher incidence of dyslipidemia (p=0.03) and proteinuria events (p=0.01), while no difference was observed in the incidence of anemia (p=0.17), new onset of post-transplant diabetes mellitus (p=1.00) or urinary tract infection (p=0.60). The mean eGFR was similar in both groups. Conclusion: Our study did not show viral load decrease after conversion to EVR with maintenance of antiproliferative therapy.

scholarly journals A CLINICAL STUDY TO ASSESS THE EFFICACY OF SHWASAHARA DASHEMANI GHANAVATI IN CARDIAC ASTHMA W.S.R L.V.F

2021 ◽  
Vol p6 (1) ◽  
pp. 3179-3185
Author(s):  
Roopa M.R ◽  
Vasudev A Chate ◽  
Shreevathsa Shreevathsa ◽  
Mohan Kumar G
Keyword(s):  
Standard Treatment ◽  
Intervention Group ◽  
Simple Random Sampling ◽  
Control Group ◽  
P Value ◽  
Common Symptom ◽  
Open Label ◽  
Post Test ◽  
Clinically Significant ◽  
Cardiac Asthma

Introduction: Shwasa is said as Shigrapranahara Roga. It occurs as the main disease and also a symptom in various diseases. Shwasakruchrata is a common symptom that occurs in Hrudroga. Acharya Charaka mentioned the unique classification of drugs based on their action. Shwasahara Dashemani is one among them. It is containing 10 herbal drugs which are specially indicated in Shwasa Roga. Hence to evaluate the efficacy of Shwasahara Dashemani in Lakshana Roopi Shwasa in L.V.F (Cardiac Asthma) has taken for the study. Aim and Objective: The objective is to assess the efficacy of Shwasahara Dashemani in L.V.F with dyspnea (Cardiac Asthma). Method: The present study is a controlled comparative, open-label, clinical trial with pre and post-test design. A total of 40 subjects of a diagnosed case of L.V.F with dyspnea (Cardiac Asthma) were selected by using a simple random sampling method. Control group subjects were intervened with standard treatment of L.V.F and intervention group subjects were intervened with standard treatment of L.V.F along with Shwasahara Dashemani Ghana Vati, for the duration of 30 days. Its efficacy was assessed before treatment (0th day) and after treatment (31st day) by using BDI (Baseline Dyspnea Index Scale). Results: The P-value of dyspnea of the control group is 1.000 and the P-value of dyspnea of the intervention group is 0.105. This shows that the results of both groups are statistically not significant. But as compared to the control group, the intervention group is clinically significant because after the intervention 35% of subjects had shown improvement in the intervention group. Conclusion: As compared to the control group, in the intervention group Shwasahara Dashemani Ghanavati is clinically significant in relieving cardiac asthma when used with standard treatment of L.V.F. Keyword: Shwasahara Dashemani. Cardiac Asthma, L.V.F, Dyspnea

scholarly journals Can 2-Aticyto Complex be an Effective Agent for Recovery of The Symptoms and Enhancing Laboratory Parameters in COVID-19 Patients?

2021 ◽  
Vol 3 (2) ◽  
pp. 35-39
Author(s):  
Ferhan Kerget ◽  
Buğra Kerget ◽  
Alperen Aksakal ◽  
Abdullah Osman Koçak
Keyword(s):  
Clinical Symptoms ◽  
Clinical Course ◽  
Symptomatic Treatment ◽  
Clinical Situation ◽  
National Guideline ◽  
Control Group ◽  
Effective Agent ◽  
Laboratory Parameters ◽  
Taste And Smell ◽  
D Dimer

Background: SARS-CoV-2 (Covid-19) pandemic which was firstly identified in Wuhan/China in December 2019.There still exists no precise treatment for this pandemic yet despite many agents are tried in prophylaxis and treatment for Covid-19. In this study, we aimed to investigate the efficacy of 2-aticyto complex in clinical course in these patients. Materials and Methods: 150 patients who applied to the Infection Diseases Polyclinics between dates September 2020-November 2020 having diagnosed with Covid-19 were included in our study. The patients were randomized into 2 groups (75 in each group) of which the first group only had the treatment of National Guideline and the second group had Viruthol® including 2-aticyto complex (at the dose of 27000 mcg/day) in addition to the treatment of the National Guideline. The laboratory parameters, clinical outcomes and the first day on which PCR result turned into negative of the patients were compared. Results: In Viruthol® group, LDH, CRP, D-Dimer and ferritin levels were significantly decreased compared to the control group, while lymphocyte levels were higher. (p=0.02, p=0.001, p=0.01, p=0.02, p=0,001 respectively).  In addition to that, clinical symptoms such as fever, headache, weakness, loss of taste and smell and muscle-joint pain recovered more rapidly in contrast with the control group (p=0.001, p=0.05, p=0.001, p=0.001, p=0.001, respectively). PCR results of the Viruthol® group turned negative in a statistically significant shorter period of time with respect to the control group (p=0.001). Conclusion: Viruthol® containing 2-aticyto complex may be an agent that can be used both symptomatic treatment and improving the clinical situation and recovery of the patients followed up for Covid-19.

Abstract 2562: Two-Year Clinical Follow-Up of COREA-TAXUS Trial: Long-Term Safety And Efficacy of Celecoxib for 6 Months After Paclitaxel-Eluting Stents Implantation

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Jin-Wook Chung ◽  
Han-Mo Yang ◽  
Dong-A Kwon ◽  
Jung-Won Suh ◽  
Kyung-Woo Park ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Cardiac Death ◽  
Target Lesion ◽  
Controlled Study ◽  
Control Group ◽  
Cardiac Events ◽  
Open Label ◽  
Adverse Cardiac Events ◽  
Fatal Myocardial Infarction

Background: The effect of celecoxib on restenosis after angioplasty with a Taxus stent (COREA-TAXUS) trial is an open-label randomized controlled study, where we reported celecoxib was effective in reducing 6months late loss of Taxus stent. With this cohort, we analyzed long-term clinical outcomes. Method: Two hundred sixty seven patients underwent successful paclitaxel-eluting stents implantation for native coronary lesions. Patients were randomized to receive celecoxib (400 mg before the intervention, and 200 mg twice daily for 6 months after the procedure) or not. Clinical endpoints were cardiac death, non-fatal myocardial infarction, and revascularization of the target lesion. Results: At 6 months, frequency of adverse cardiac events was significantly lower in the celecoxib group (5.3% versus 16.2%, P=0.005), mainly because of reduced need for revascularization of the target lesion (5.3% versus 15.4%, P=0.009). Between 6 and 24 months, frequency of adverse cardiac events was not different between the celecoxib group and the control group (1.6% versus 4.4%, P=NS: 0% versus 0% for cardiac death; 0.8% versus 0.9% for non-fatal myocardial infarction; 0.8% versus 3.5% for revascularization of target lesion, P=all NS). At 2 years, frequency of adverse cardiac events was still significantly lower in the celecoxib group (6.9% versus 19.9%, P=0.002) Conclusion: In the COREA-TAXUS trial, the adjunctive use of celecoxib for 6 months after Taxus stent implantation was safe and clinically effective for 2 years.

Effect of an Information Leaflet on Breast Cancer Screening Participation. A Randomized Controlled Study

2021 ◽  
Author(s):  
Jose Maria Montero-Moraga ◽  
Margarita Posso ◽  
Marta Román ◽  
Andrea Burón ◽  
Maria Sala ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Socioeconomic Status ◽  
Cancer Screening ◽  
Breast Cancer Screening ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
P Value ◽  
Information Leaflet ◽  
Lower Socioeconomic

Abstract Objective: To evaluate the impact of an information leaflet about the risk-benefit balance of breast cancer screening on women’s participation.Methods: This randomized controlled study was conducted within a population-based breast cancer screening program and included women from the catchment areas of two hospitals in Barcelona, Spain. We evaluated women aged 50-69 years invited to screening between September 2019 and January 2020. One hospital attended a population with a lower socioeconomic status than the other. The intervention group received an information leaflet on the benefits and harms of mammography screening. The control group received the usual invitation letter. We compared the participation rate between groups, stratified by hospital and by per-protocol and intention-to-treat analyses. Results: We included 11,119 women in the study: 5,416 in the intervention group and 5,703 in the control group. A total of 36.4% (1,964/5,393) of the women in the intervention group and 37.5% (2,135/5,694) of those in the control group attended screening, respectively. Overall, we found no differences in participation among groups (difference in participation -1.1%; 95% CI; -2.9% to 0.7%, p-value=0.240). In the hospital attending a population with a low socioeconomic status, attendance was lower in the intervention group (-1.4%, 95% CI: -5.7% to -0.03%, p-value=0.029). In the per-protocol analysis, participation was lower in the intervention group (-2.6%, 95% CI: -4.6% to -0.5%, p-value=0.015). Conclusions: Overall participation in our program was unaffected by a new information leaflet on the risk-benefit balance of breast cancer screening. However, participation was lower in certain populations with lower socioeconomic status.

scholarly journals Combination Preemptive Peripheral Nerve Block in Limb Surgery. A Prospective Study

Medicina ◽  
2020 ◽  
Vol 56 (8) ◽  
pp. 388
Author(s):  
I-Cheng Lu ◽  
Shu-Hung Huang ◽  
David Vi Lu ◽  
Chun Dan Hsu ◽  
Sheng Hua Wu
Keyword(s):  
Pain Management ◽  
Peripheral Nerve ◽  
Nerve Block ◽  
Peripheral Nerve Block ◽  
Recovery Period ◽  
Controlled Study ◽  
Control Group ◽  
Single Shot ◽  
Early Recovery ◽  
The Impact

Background and objectives: Patients often suffer from moderate to severe pain during the early recovery period in orthopedic surgery. We investigated the impact of a single-shot preoperative peripheral nerve block (PNB) on post-anesthesia recovery parameters and interleukin (IL)-6 level during limb surgery. Materials and Methods: A prospective randomized controlled study was conducted, and patients scheduled for limb surgery were recruited. Sixty patients were randomly assigned to either the PNB group or control group, who received morphine as a primary analgesic. The peak verbal numeric rating scale (NRS) score in the post-anesthesia care unit (PACU) was evaluated as a primary outcome. We also recorded rescue analgesics requirement and wake-up time from anesthesia in the PACU. In addition, the change of plasma IL-6 level after incision was measured. Results: Fifty-two patients completed the study, 27 and 25 cases in the PNB and control group, respectively. Preemptive PNB significantly reduced peak NRS score in the PACU compared to control group. Lower rescue analgesics requirement and rapid wake-up from anesthesia were also noted in PNB group. The IL-6 concentration increased less in the PNB group at 2 h after incision. Conclusions: Preemptive PNB attenuates IL-6 expression 2 h after incision and improves pain management in the PACU. PNB was considered as an essential part of pain management in limb surgery.

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