The results of the clinical trials on the efficacy and safety of the over-the-counter Lagundi syrup and tablet in treating mild symptoms of coronavirus disease (COVID-19) cannot be used for marketing lagundi products, the Philippine Council for Health Research and Development Department of Science and Technology-(DOST-PCHRD) said.
The DOST-PCHRD warned the public against the unauthorized use of the results of the lagundi study, led by Dr. Cecilia Maramba-Lazarte of the University of the Philippines Manila-National Institute of Health (UPM-NIH).
“The study showed that lagundi may be beneficial to mild cases of COVID-19. Despite this, we’d like to emphasize that the results of the clinical trials on lagundi against COVID-19 cannot be utilized by any product other than the one used in the trials without the conduct of similar clinical trials,” DOST-PCHRD Executive Director Dr. Jaime C. Montoya said in a statement.
"We encourage the public to be on the lookout for misleading product claims,” he added.
Funded by the DOST-PCHRD, the UPM study sought to evaluate the efficacy and safety of the over-the-counter 600 milligrams (mg) lagundi syrup and tablet in treating mild symptoms of COVID-19. The Lagundi syrup and tablet were formulated through the National Integrated Research Program on Medicinal Plants (NIRPROMP).
Based on the study, the Lagundi products approved by the Food and Drug Administration (FDA) can be safely used for the symptomatic treatment of mild COVID-19.
“If taken three times a day, the products were found to be effective in decreasing mild COVID-19 symptoms, especially anosmia (loss of sense of smell), and in providing overall relief of discomfort from other symptoms,” the PCHRD said.
“The results, however, cannot be used as a basis for proving the efficacy and safety of using lagundi against COVID-19 in any form or product other than the one used or tested during the trial,” it stressed.
The Council said clinical trials validate the efficacy and safety of specific formulations using a specified dose for use against a specific disease.
Any product that has therapeutic claims would require successful clinical trials and approval from the country’s FDA before marketing to the public, it reminded.
“Our study only focused on evaluating the NIRPROMP formulation of the Lagundi syrup and tablet for mild COVID-19. Accordingly, we have not endorsed any other Lagundi product aside from these, and any other product claims separate from what we studied are not affiliated with the project team, nor UP-Manila,” said Maramba-Lazarte.
In July 2020, it was announced that the clinical trials for lagundi were approved by DOST-PCHRD. In April last year, the DOST started looking at the effectiveness of certain herbal medicines against COVID-19.
Lagundi is widely used as a cough remedy.
The FDA approved the clinical trials for lagundi as a supplemental treatment against COVID-19 in August 2020.