scholarly journals Combination of Hua Shi Bai Du Granule (Q-14) and Standard Care in the Treatment of Patients with Coronavirus Disease 2019 (COVID-19): A Single-center, Open-label, Randomized Controlled Trial

Phytomedicine ◽  
2021 ◽  
pp. 153671
Author(s):  
Jia Liu ◽  
Wei Yang ◽  
Yue Liu ◽  
Cheng Lv ◽  
Lianguo Ruan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Single Center ◽  
Open Label ◽  
Randomized Controlled ◽  
Q 14

scholarly journals An open label randomized controlled trial of tamoxifen combined with amphotericin B and fluconazole for cryptococcal meningitis

eLife ◽  
2021 ◽  
Vol 10 ◽  
Author(s):  
Nguyen Thi Thuy Ngan ◽  
Nhat Thanh Hoang Le ◽  
Nguyen Ngo Vi Vi ◽  
Ninh Thi Thanh Van ◽  
Nguyen Thi Hoang Mai ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cryptococcal Meningitis ◽  
Standard Care ◽  
Therapeutic Potential ◽  
Controlled Trial ◽  
High Dose ◽  
Open Label ◽  
Randomized Controlled ◽  
Cancer Agent

Background: Cryptococcal meningitis has high mortality. Flucytosine is a key treatment but is expensive and rarely available. The anti-cancer agent tamoxifen has synergistic anti-cryptococcal activity with amphotericin in vitro. It is off-patent, cheap, and widely available. We performed a trial to determine its therapeutic potential.Methods:Open label randomized controlled trial. Participants received standard care - amphotericin combined with fluconazole for the first two weeks - or standard care plus tamoxifen 300mg/day. The primary end point was Early Fungicidal Activity (EFA) - the rate of yeast clearance from cerebrospinal fluid (CSF). Trial registration https://clinicaltrials.gov/ct2/show/NCT03112031 .Results: 50 patients were enrolled, (median age 34 years, 35 male). Tamoxifen had no effect on EFA (- 0.48log10 colony-forming units/mL/CSF control arm versus -0.49 tamoxifen arm, difference - 0.005log10CFU/ml/day, 95%CI: -0.16, 0.15, P=0.95). Tamoxifen caused QTc prolongation.Conclusion: High dose tamoxifen does not increase the clearance rate of Cryptococcus from CSF. Novel, affordable therapies are needed.Funding:The trial was funded through the Wellcome Trust Asia Programme Vietnam Core Grant 106680 and a Wellcome Trust Intermediate Fellowship to JND grant number WT097147MA.

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.

scholarly journals The effectiveness and safety of Tai Chi for patients with essential hypertension: study protocol for an open-label single-center randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yuxi Li ◽  
Dongling Zhong ◽  
Chao Dong ◽  
Lihong Shi ◽  
Yaling Zheng ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Essential Hypertension ◽  
Tai Chi ◽  
Controlled Trial ◽  
Waiting List ◽  
Single Center ◽  
Open Label ◽  
Hypertensive Patients ◽  
Randomized Controlled

Abstract Background Evidence showed that Tai Chi may have beneficial effects among hypertensive individuals, although the results are not convincing. We aim to conduct a high-quality clinical trial with 24-h BP measurement to provide robust evidence of Tai Chi for essential hypertension. Methods This is an open-label single-center randomized controlled trial with 3 parallel arms. We will compare Tai Chi with walking and waiting-list control. We will recruit 234 hypertensive patients with mild to moderate essential hypertension and randomly assign them to 3 different groups. Participants in Tai Chi group will receive a group-format Yang style 24-form Tai Chi exercise program, 3 sessions per week for 12 weeks. The walking group will be asked to walk, 3 sessions per week for 12 weeks. The waiting-list group will not receive any interventions and/or exercise training. The primary outcome is the change in average 24-h systolic blood pressure (SBP) between baseline and 12 weeks after randomization. The secondary outcomes include 24-h Diastolic Blood Pressure (DBP), average SBP and average DBP during the daytime and night-time, blood pressure (BP) variability, SBP load and DBP load, circadian rhythm of BP, and morning BP surge, endothelial functional indicators, home measured BP, quality of life, adverse events and so on. Discussion We expect findings of this trial will provide important insight into application of Tai Chi as an effective and acceptable method for hypertensive patients. Successful completion of this proposed study will also contribute to promotion of Tai Chi in the community in the future. Trial registration Clinicaltrials.gov registry: https://clinicaltrials.gov/ct2/show/NCT04267471, date: February 12, 2020.

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