Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810689
Status:
TERMINATED
Last Update Posted:
2022-06-27
First Post:
2021-03-17
Brief Title:
Pilot Trial of XFBD a TCM in Persons With COVID-19
Sponsor:
Darcy Spicer
Organization:
University of Southern California
Study Overview
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
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futile Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 11 individuals
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 11 individuals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None