Approach to Study the Efficacy and Safety of New Complementary and Alternative Medicine Formulations: Lesson during COVID-19 from Sri Lanka.

COVID-19 affected Sri Lanka from early 2020, a time of considerable ignorance accompanied by wide media coverage of a devastating epidemic in Italy and Europe. Many were attracted to complementary and alternative medicine (CAM) or traditional medicine (TM) in this desperate situation. Several preparations were claimed to be effective against COVID-19 globally. Dammika Bandara Syrup© was one such preparation promoted for preventing and treating SARS-CoV-2 infection. It was based on bees' honey, pericarp and mace of Myristica fragrans (nutmeg), the seed of Foeniculum vulgare and fresh rhizome of Zingiber officinale, all believed to have anti-viral properties. Following an unpublished clinical study claiming efficacy, Dammika Bandara Syrup© gained wide media publicity and political patronage. The producer claimed of Goddess Kali revealing the formula added an anthropological, cultural, and religious complexity to the issue. The demand for the product increased rapidly as a debate raged both in public and in the parliament on utilizing such products in combating COVID-19. The Department of Ayurveda, which is statutorily responsible for regulating CAM/TM had to respond to the situation. The legislation to regulate such indigenous medicinal products was weak, and the crisis deepened as thousands converged to the production facility, defying mobility restrictions introduced to control COVID-19. This led to the Ministry of Health requesting academics to form a team and conduct a clinical trial to prove its efficacy. This paper outlines the process and issues faced during the regulatory approval for the trial in a polarized political environment. Some health professionals accused the researchers of bowing to political pressure and questioned the scientific justification for the trial. However, the team considered this as an opportunity to streamline a path for research into CAM/TM therapies in situations such as COVID-19. Several processes were identified and addressed, such as the provisional registration of CAM preparations, assessing the potential efficacy of a CAM product, confirmation of authenticity and safety, standardization and supervision of production respecting cultural identities, obtaining approval for human use, choice of comparators, and ethical issues. We believe the study has helped set standards and a benchmark for CAM and TM research in Sri Lanka.

Hantavirus Infections-Treatment and Prevention.

PURPOSE OF REVIEW: Hantavirus infection is an emerging zoonosis and there are two main clinical presentations, hemorrhagic fever with renal syndrome (HFRS) and Hantavirus pulmonary syndrome (HPS). Although Hantavirus infections have a worldwide distribution with a high mortality rate, a safe and effective vaccine or an antiviral drug against the Hantavirus disease is yet to be available. This review summarizes all the efforts undertaken to develop medical countermeasures in vitro, in vivo, and human clinical trials against Hantavirus infections. RECENT FINDINGS: Multiple antivirals are shown to be effective with limited evidence and recent studies on immunotherapy were not very conclusive. There are multiple vaccine candidates with evidence of conferring long protective immunity against Hantaviruses. Some of these had been already trialed on humans. SUMMARY: At present, severe HPS or HFRS case management is purely based on supportive treatments, often in an intensive care unit. Rodent control and public health education and promotion play a major role in preventing Hantavirus infection.

Features of Covid-19 patients detected during community screening: A study from a rural hospital in Sri Lanka.

ABSTRACT: We studied the clinical course and virus shedding of all patients referred to Welikanda Hospital, in one month. There were 53 positives for Covid-19 by PCR. 24 (45%) were male, with an age range of 11-94 years. Of these, 41 (77%) were asymptomatic, 9 had cough, 4 had sore throat and six had fever. Pulse, blood pressure, respiratory rate and capillary oxygen were normal in all. A proportion of them had poor prognostic factors: asthma (n=4), hypertension (n=11), age above 60 years (n=9), and diabetes (n=11). Lymphopenia was seen in 20 and elevated CRP in 14. Viral shedding continued beyond 14 days in several persons and continued in symptomatic patients for a significantly longer time than asymptomatic patients. Covid-19 was an asymptomatic or mild illness in this group of people. Several of them continued to be RT-PCR positive even after 14 days. Such cases are an important source of community spread.