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BerberineWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug1782 Montmorrillonite Wiki 1.00
drug1552 Lanadelumab Wiki 0.58

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D000799 Angioedema NIH 0.71
D054179 Angioedemas, Hereditary NIH 0.71

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0100665 Angioedema HPO 0.71

There is one clinical trial.

Clinical Trials

1 The Effect of Berberine on Intestinal Function and Inflammatory Mediators in Severe Patients With Covid-19

Coronavirus disease 2019 (COVID-19) rapidly spread across China and throughout the world, causing hundreds of thousands died. Studies had shown that "cytokine storms" and subsequent multiple organ dysfunction (MODS) are important causes for disease progression and death in patients with COVID-19. Similar to SARS-CoV infection, SARS-CoV-2 would infect humans via binding of S-protein to angiotensin-converting enzyme 2 (ACE2), a host cell receptor, and the S protein is activated and cleaved by cellular transmembrane serine proteases, allowing the virus to release fusion peptides for membrane fusion. In addition to the lungs, ACE2 is also highly expressed in the esophagus, small intestine and colon, suggesting that the gut might also be an important target organ for SARS-CoV-2. About 8-16% of severe pneumonia cases confirmed with SARS-CoV-2 infection developed gastrointestinal symptoms such as abdominal pain, vomiting, and diarrhea. Moreover, the stool of patient with COVID-19 also positive by real-time reverse-transcriptase-polymerase-chain-reaction (rRT-PCR) assay. Furthermore, elevated faecal calprotectin was observed in patients with COVID-19 suggested an inflammatory response in the gut, which was significantly correlated with IL-6. For severe and critical cases, control "cytokine storms" and maintain intestinal microenvironment balance have been included into the Diagnosis and Treatment Guideline of patients with COVID-19 (Edition 7). Berberine is a quaternary ammonium alkaloid isolated from rhizoma coptidis. It is often used in treatment of infectious diarrhea by bacteriostasis and inhibition of intestinal gland secretion. Berberine has also been found to have a role in intestinal immune regulation, inhibiting both AP-1 and NF- B, the key factors in cell signal transduction, and reducing the inflammatory response. Investigators conducted a prospective randomized controlled clinical trial to investigate the effects of berberine on intestinal function, serum concentrations of the inflammatory biomarkers, and organ function in severe patients with SARS-CoV-2 infection.

NCT04479202 Berberine COVID-19 Drug: Berberine Drug: Montmorrillonite

Primary Outcomes

Description: Including diarrhea in times/day, Bristol Stool Scale (the minimum 1 and maximum 7, a higher scores mean a worse outcome) and whether patient has any one of gastrointestinal symptoms (nausea, vomiting, abdominal pain, abdominal distension or diarrhoea).

Measure: Changes in diarrhea frequency and Bristol Stool Scale

Time: daily, from date of randomization until the date of discharge or date of death from any cause, assessed up to 2 weeks.

Secondary Outcomes

Description: evaluate inflammatory response, blood sample collected at 6:00am

Measure: IL-6 (ng/ml)

Time: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause

Description: evaluate inflammatory response, blood sample collected at 6:00am

Measure: IL-10（ng/ml）

Time: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause

Description: evaluate inflammatory response, blood sample collected at 6:00am

Measure: IL-1β (ng/ml)

Time: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause

Description: evaluate inflammatory response, blood sample collected at 6:00am

Measure: TNF-α (pg/ml)

Time: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause

Description: evaluate inflammatory response, blood sample collected at 6:00am

Measure: leukocyte count (10^9/l)

Time: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause

Description: evaluate inflammatory response, blood sample collected at 6:00am

Measure: c reactive protein (mg/l)

Time: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause

Description: evaluate inflammatory response, blood sample collected at 6:00am

Measure: procalcitonin (ng/ml)

Time: baseline (at admission), day 3,7 and14 after admission or until the date of discharge or date of death from any cause

Other Outcomes

Description: evaluate the severity of the disease(the minimum 0 and maximum 24, a higher scores mean a worse outcome)

Measure: Sequential Organ Failure Assessment (SOFA) score

Time: baseline (at admission), day 3, 7 and 14 after admission or until the date of discharge or date of death from any cause

No related HPO nodes (Using clinical trials)