Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-30 @ 10:50 PM
Study NCT ID:
NCT05275933
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2022-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of TCM Capsules Lian Hua Qing Wen Jiao Nang in Mild COVID-19 Patients
Sponsor:
Singapore Chung Hwa Medical Institution
Organization:
Study Overview
Official Title:
Assessing the Efficacy of TCM Capsules Lian Hua Qing Wen Jiao Nang as Adjuvant Treatment in Mild COVID-19 Patients on Home Recovery Program in Singapore: a Randomised, Double-blind, Placebo-controlled Study
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research aims to investigate the adjuvant effect of LH in reducing the symptomatic duration of fully vaccinated, mild COVID-19 patients on home recovery program in Singapore. It is aimed to assist policymakers in incorporating clinically proven TCM treatment for mild COVID-19 patients on home recovery program, and establishing a guideline on TCM pandemic treatment protocol which is suitable to be integrated into the healthcare system.
Detailed Description:
Importance With the emergence of Covid-19 variants and despite having 93% population vaccination rate, the daily number of community cases in Singapore is still surging. Lian Hua Qing Wen Capsules (LH) was reported to have effective inhibitory action on Delta SARS-CoV-2 in-vitro. Due to limited availability and prioritisation of approved anti-viral drugs (Paxlovid) to moderate and severe inpatients, validating Traditional Chinese Medicine (TCM) intervention LH as a good adjuvant treatment for local population on home recovery program is important.
Objectives This research aims to investigate the adjuvant effect of LH in reducing the symptomatic duration of fully vaccinated, mild COVID-19 patients on home recovery program in Singapore. It is aimed to assist policymakers in incorporating clinically proven TCM treatment for mild COVID-19 patients on home recovery program, and establishing a guideline on TCM pandemic treatment protocol which is suitable to be integrated into the healthcare system.
Hypothesis The investigators hypothesize TCM intervention could shorten (1) the time of 8 major clinical symptoms of COVID-19 to no symptoms and (2) lesser days to COVID-19 Antigen Rapid Test (ART) negativity by 1.5 times in mild COVID-19 patients on home recovery program.
Methods 300 eligible participants will be enrolled. Equal number of participants will be randomised and double blinded in the two arms of placebo control and LH, both with standard care. Communication and consultation will be conducted through telecommunication. Primary outcome measures time to no symptoms. Secondary outcomes measure days to ART negativity, symptom severity scores and risk ratio. Exploratory outcomes include days of TCM Excess syndromes (symptoms caused by pathogenic factors) will be collated.
Significance Adjuvant treatment of mild COVID-19 patients can shorten symptomatic duration, slow disease progression, mitigate post-isolation COVID-19 symptoms, and allow isolated individuals to return to the community earlier.
Objectives This research aims to investigate the adjuvant effect of LH in reducing the symptomatic duration of fully vaccinated, mild COVID-19 patients on home recovery program in Singapore. It is aimed to assist policymakers in incorporating clinically proven TCM treatment for mild COVID-19 patients on home recovery program, and establishing a guideline on TCM pandemic treatment protocol which is suitable to be integrated into the healthcare system.
Hypothesis The investigators hypothesize TCM intervention could shorten (1) the time of 8 major clinical symptoms of COVID-19 to no symptoms and (2) lesser days to COVID-19 Antigen Rapid Test (ART) negativity by 1.5 times in mild COVID-19 patients on home recovery program.
Methods 300 eligible participants will be enrolled. Equal number of participants will be randomised and double blinded in the two arms of placebo control and LH, both with standard care. Communication and consultation will be conducted through telecommunication. Primary outcome measures time to no symptoms. Secondary outcomes measure days to ART negativity, symptom severity scores and risk ratio. Exploratory outcomes include days of TCM Excess syndromes (symptoms caused by pathogenic factors) will be collated.
Significance Adjuvant treatment of mild COVID-19 patients can shorten symptomatic duration, slow disease progression, mitigate post-isolation COVID-19 symptoms, and allow isolated individuals to return to the community earlier.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: