دورية أكاديمية
Natural tannin extracts supplementation for COVID-19 patients (TanCOVID): a structured summary of a study protocol for a randomized controlled trial.
| العنوان: | Natural tannin extracts supplementation for COVID-19 patients (TanCOVID): a structured summary of a study protocol for a randomized controlled trial. |
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| المؤلفون: | Molino, Silvia, Pisarevsky, Andrea, Mingorance, Fabiana Lopez, Vega, Patricia, Stefanolo, Juan Pablo, Repetti, Julieta, Ludueña, Guillermina, Pepa, Pablo, Olmos, Juan Ignacio, Fermepin, Marcelo Rodriguez, Uehara, Tatiana, Villapol, Sonia, Savidge, Tor, Treangen, Todd, Viciani, Elisa, Castagnetti, Andrea, Piskorz, Maria Marta |
| سنة النشر: | 2021 |
| المجموعة: | Sistema Sanitario Público de Andalucía (SSPA): Repositorio |
| مصطلحات موضوعية: | COVID-19, Chestnut tannins, Quebracho tannins, Randomized controlled trial, gut microbiota, inflammation, protocol, Adolescent, Adult, Argentina, Dietary Supplements, Female, Humans, Lactation, Plant Extracts, Pregnancy, Prospective Studies, RNA, Viral, Randomized Controlled Trials as Topic, SARS-CoV-2, Tannins, Treatment Outcome |
| الوصف: | This research aims to study the efficacy of tannins co-supplementation on disease duration, severity and clinical symptoms, microbiota composition and inflammatory mediators in SARS-CoV2 patients. This is a prospective, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the efficacy of the administration of the dietary supplement ARBOX, a molecular blend of quebracho and chestnut tannins extract and Vit B12, in patients affected by COVID-19. 18 years of age or older, admitted to Hospital de Clinicas Jose de San Martin, Buenos Aires University (Argentina), meeting the definition of "COVID-19 confirmed case" ( https://www.argentina.gob.ar/salud/coronavirus-COVID-19/definicion-de-casoTest ). Inclusion Criteria Participants are eligible to be included in the study if the following criteria apply: 1. Any gender 2. ≥18 years old 3. Informed consent for participation in the study 4. Virological diagnosis of SARS-CoV-2 infection (real-time PCR) Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: 1. Pregnant and lactating patients 2. Patients who cannot take oral therapy (with severe cognitive decline, assisted ventilation, or impaired consciousness) 3. Hypersensitivity to polyphenols 4. Patients already in ICU or requiring mechanical ventilation 5. Patients already enrolled in other clinical trials 6. Decline of consent INTERVENTION AND COMPARATOR: Experimental: TREATED ARM Participants will receive a supply of 28 -- 390 mg ARBOX capsules for 14 days. Patients will be supplemented with 2 capsules of ARBOX per day. Placebo Comparator: CONTROL ARM Participants will receive placebo supply for 14 days. The placebo will be administered with the identical dose as described for the test product. All trial participants will receive standard therapy, which includes: Antipyretics or Lopinavir / Ritonavir, Azithromycin and Hydroxychloroquine, as appropriate (treatment currently recommended by the department of Infectious Diseases of the Hospital de Clínicas ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1745-6215 |
| العلاقة: | http://hdl.handle.net/10668/17648Test; PMC8080998; https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-021-05281-xTest; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8080998/pdfTest |
| DOI: | 10.1186/s13063-021-05281-x |
| الإتاحة: | https://doi.org/10.1186/s13063-021-05281-xTest http://hdl.handle.net/10668/17648Test https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8080998/pdfTest |
| حقوق: | Attribution 4.0 International ; http://creativecommons.org/licenses/by/4.0Test/ ; open access |
| رقم الانضمام: | edsbas.3F82D70F |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 17456215 |
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| DOI: | 10.1186/s13063-021-05281-x |