The Health Sciences Authority (HSA) said on Wednesday (April 20) that the purpose of the study is to assess what effect the pills, when given in addition to current standard medical treatment, may have on the time taken for fully vaccinated adults on home recovery with mild Covid-19 to recover from their symptoms.
The trial also aims to assess how the medicine may affect the time taken for someone to obtain a negative antigen rapid test (ART) result.
The randomised, double-blind, placebo-controlled study was initiated by the Singapore Chung Hwa Medical Institution, and approved by HSA on Jan 18.
The principal investigators of the study are Dr Zuraimi Mohamed Dahlan from Banyan Clinic @ JW and Dr Ong Sze Tat from Ubi Family Clinic and Surgery.
Dr Zuraimi told The Straits Times on Wednesday that a study in China had shown the pills were effective in improving the symptoms of Covid-19 patients.
But a proper double-blind, random-controlled trial is required to scientifically prove this, which is why the study was launched.
He added that the researchers need to recruit at least 300 patients, aged 21 to 79, who have just tested positive for the coronavirus.
Half the patients will receive the TCM pills, while the other half will receive a placebo. Patients in both groups will need to take the pills three times a day for seven days.
Each day, researchers will call the patients and get feedback on their ART status, pulse oximetry and well-being.
The researchers hope to conclude the trial in six months, said Dr Zuraimi.
A description of the trial on clinicaltrials.gov, a website run by the United States’ National Library of Medicine, says that the study’s investigators have hypothesised that TCM intervention could help eight major Covid-19 clinical symptoms to disappear by 1½ times faster in patients with mild Covid-19, who are on home recovery.
“Due to limited availability and prioritisation of approved anti-viral drugs (Paxlovid) to moderate and severe inpatients, validating TCM intervention (Lianhua Qingwen) as a good adjuvant treatment for local population on home recovery programme is important,” said the description.
It added that “(the research) is aimed to assist policymakers in incorporating clinically proven TCM treatment for mild Covid-19 patients on home recovery programme, and establishing a guideline on TCM pandemic treatment protocol which is suitable to be integrated into the healthcare system”.
Those who wish to participate in the trial may call Ubi Family Clinic & Surgery on 6749-7922, or Banyan Clinic @ JW on 6899-1161.
Clinics that are willing to participate in recruiting patients for the study may contact the Singapore Chung Hwa Medical Institution on 8028-0096.
Last November, HSA had warned against claims circulating on social media and in Telegram chat groups that Lianhua Qingwen products could be used to prevent or treat Covid-19.
At the time, HSA said: “To date, there is no scientific evidence from randomised clinical trials to show that any herbal product, including Lianhua Qingwen products, can be used to prevent or treat Covid-19.”
It added: “HSA requires any product that claims to treat Covid-19, to have scientific evidence from controlled clinical studies to substantiate that such a product is safe and effective against Covid-19. Such a product must first be submitted to HSA to assess the scientific evidence and be registered before it can be supplied locally.”
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