Pilot Trial of XFBD, a TCM, in Persons With COVID-19

Covid19 Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Control Pilot Trial of Xuanfei Baidu Granules (XFBD), a Traditional Chinese Medicine (TCM), in Persons With COVID-19

Status Terminated

Clinical Trial Summary

The purpose of this study is to document the safety of taking traditional Chinese medicine (TCM) in patients with COVID-19 and to gain information to determine whether a study with TCM can be conducted. The study will test a traditional Chinese medicine that has been made into a granule formulation called Xuanfei Baidu Granules.

Clinical Trial Description

Xuanfei Baidu granules (XFBD) is a 13 medicinal traditional Chinese medicine (TCM) prescription developed by Dr. Zhang Boli, a member of Chinese Academy of Engineering, and his team, and used in Wuhan, China, during the initial outbreak of SARS-CoV2. Based on TCM theory, the 13 medicinals used mainly consist of heat-clearing and toxin-removing medicinals to reduce fever and clear viruses; cough-suppressing and phlegm-transforming medicinals to thin and clear the phlegm; and lung-diffusing and pant-calming to soothe the tracheal smooth muscle and relieve shortness of breath. Another unique quality is one of the medicinals helps to dissipate stasis and dissolves blood clots, providing a mild anticoagulant effect.

Before the widespread usage of TCM, nationwide China saw a progression of disease of about 10% of their mild and moderate cases while during the period with the TCM utilization, the percentage dropped to 2-5% depending on the hospital. Overall, they saw an improvement of clinical symptoms. Due to the challenges of the rapidly evolving outbreak, these are clinical observations and not evidence from a controlled study.

The purpose of this initial pilot study is to document the safety of taking a TCM in patients with COVID-19 and to gain information to determine whether a study with TCM can be conducted in the US. The study will test a TCM which has been made into a granule formulation called XFBD.

This is a randomized double-blind placebo-control pilot trial to document safety and efficacy endpoint assessments and to determine the feasibility of community recruitment and enrollment of symptomatic adult outpatients with COVID-19. The 12-week pilot will have 14 days where they receive XFBD or a placebo, orally twice a day and a 10 week follow up. The study will have a total of 60 participants with approximately 30 participants in each treatment arm. The participants will be randomized 1:1 individuals. ;

Related Conditions & MeSH terms

• COVID-19
• Covid19

• NCT number: NCT04810689
• Study type: Interventional
• Source: University of Southern California
• Status: Terminated
• Phase: Phase 2
• Start date: March 1, 2021
• Completion date: June 20, 2022