Browsing by Author "Lekamwasam, S."

Now showing 1 - 3 of 3

Approach to study the efficacy and safety of new complementary and alternative medicine formulations: Lesson during COVID-19 from Sri Lanka
(Wolters Kluwer - Medknow, 2023) Pilapitiya, S.; Jayasinghe, S.; Silva, A.; Wickremasinghe, R.; Paranagama, P.; de Silva, J.; Lekamwasam, S.; Kularatne, S.A.M.; Wanigasuriya, K.; Kaluthota, S.; Sumathipala, S.; Rathnnasooriya, C.; Siribaddana, S.
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 Following an unpublished clinical study claiming efficacy, Dammika Bandara Syrup© gained wide media publicity and political patronage.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.
Features of Covid-19 patients detected during community screening: A study from a rural hospital in Sri Lanka.
(The Sri Lanka Medical Association., 2020) Senanayake, A.P.; Indrakantha, D.; Sumathipala, S.; Wanigasuriya, K.; Kularathne, S.; Lekamwasam, S.; Jayasinghe, S.; de Silva, H.J.; Siribaddana, S.
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.
Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial
(BioMed Central, 2020) Niriella, M.A.; Ediriweera, D.S.; de Silva, A.P.; Premaratna, R.; Balasooriya, P.; Duminda, K.D.; Malavige, N.G.; Wanigasuriya, K.; Lekamwasam, S.; Kularathne, S.A.; Siribaddana, S.; de Silva, H.J.; Jayasinghe, S.
BACKGROUND: The first case of a coronavirus 2019 (COVID-19) infection in a Sri Lankan was reported on March 11, 2020. The situation in Sri Lanka changed with the rapid increase of personnel contracting COVID-19 in a naval base camp that housed more than 4000 people. This provided a unique opportunity to study the effectiveness of hydroxychloroquine (HCQ) for post-exposure prophylaxis (PEP), while taking stringent, non-pharmacologic, public health measures to prevent spread. Our aim is to study the effectiveness and safety of HCQ for PEP among naval personnel with exposure to COVID-19-positive patients. METHODS/DESIGN: This is a placebo-controlled, randomized, clinical trial carried out in the naval base camp and quarantine centers of the Sri Lanka Navy, Ministry of Defense, Sri Lanka. Navy personnel who are exposed to a patient with confirmed COVID-19 infection but test negative for the virus on reverse real-time polymerase chain reaction (rRT-PCR) at recruitment will be randomized, 200 to each arm, to receive HCQ or placebo and monitored for the development of symptoms or rRT-PCR positivity for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus for 14 days. DISCUSSION: This trial will provide high-quality evidence of the effectiveness and safety of HCQ as PEP for COVID-19. The study design is unique due to the circumstances of the outbreak in a confined area among otherwise healthy adults, at a relatively early stage of its spread. TRIAL REGISTRATION: Sri Lanka Clinical Trials Registry (SLCTR) SLCTR/2020/011. Registered on 04 May 2020. KEYWORDS: COVID-19; HCQ; Hydroxychloroquine; Post-exposure; Prophylaxis; Randomized controlled trial; SARS-CoV-2; Sri Lanka.