Efficacy of TCM Capsules Lian Hua Qing Wen Jiao Nang in Mild COVID-19 Patients
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): TCM intervention; Placebo intervention
Intervention type(s): Other; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomised, double-blind, placebo-controlled study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment