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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
93
Lian Hua Qing Wen Capsules (LH) are provided in addition to Standard Care medications which include Symptomatic therapies include Paracetamol, antihistamines (eg. Cetirizine, loratadine or chlorpheniramine) and etc pro re nata (PRN) basis accordingly to the patient's condition.
Placebo Capsules (PC) are provided in addition to Standard Care medications which include Symptomatic therapies include Paracetamol, antihistamines (eg. Cetirizine, loratadine or chlorpheniramine) and etc pro re nata (PRN) basis accordingly to the patient's condition.
Ubi Family Clinic & Surgery
Singapore, Singapore
Banyan clinic @ jw private limited
Singapore, Singapore
1.1 Time (Days) to become asymptomatic (the event) for all 8 major COVID-19 symptoms.
To document the adjuvant effect of LH on Symptom Severity Score within 7 days of enrolment in the PC + standard care and LH + standard care treatment at Day 1 to Day 7 every day. 8 major Covid-19 symptoms: Stuffy or runny nose, Sore throat, Cough, Low energy or tiredness, Muscle or body aches, Headache, Chills or shivering, Feeling hot or feverish. The time (days) to become asymptomatic (the event) is defined as when all the 8 major Covid-19 symptoms meet the criteria of disappearing (score 0) and are stable for at least 24 hours.
Time frame: up to 7 days after enrolment
2.1 Median Time to COVID-19 ART negativity
Detection of SARS-CoV-2 viral proteins (antigens) in respiratory tract specimens using a standardised locally approved self-administering Antigen Rapid Test (ART) Kit of the same brand and model daily from Day 1 to Day 7. • Time to COVID-19 ART negativity (the event) will be recorded, and are ART negative for the next additional 2 days.
Time frame: up to 7 days after enrolment
2.2 Symptom Severity Score
To investigate symptom recovery and mean reduction score (defined as absolute differences of the overall symptom severity scores from baseline day 1) comparison between 2 arms on days 1-7, 28 specifically. * Overall symptom severity score (added together) for the following symptoms will be calculated: * Stuffy or runny nose * Sore throat * Cough * Low energy/tiredness * Muscle/body aches * Headache * Chills/shivering * Fever/Feeling hot/feverish * Sense of smell * Sense of taste * The lower the score the less intensity the symptoms are. For each symptoms (with specific definitions), 0 point represents no symptoms, 1 point represent mild, 2 point represent moderate and 3 point represents severe.
Time frame: up to 7 days and on the 28th day after enrolment
2.3 Adverse Events
To document observed cumulative incidence of adverse events including event that leads to early discontinuation of PC+SC or LH+SC. Incidence of serious adverse events including COVID-19 disease worsening requiring medical intervention and/or hospitalization within 28 days will also be recorded and reported.
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Time frame: up to 7 days and on the 28th day after enrolment
2.4 Time to become asymptomatic (the event) for the 3 Covid-19 symptoms of interest
The time (days) to become asymptomatic (the event) for the 3 major Covid-19 symptoms of Stuffy or runny nose, Sore throat and Cough and meet the criteria of disappearing (score 0) and are stable for at least 24 hours.
Time frame: up to 7 days after enrolment