ABSTRACT
Background: The COVID-19 pandemic influenced dietary supplements' (DS) consumption and practices of traditional medicine. Aims: This cross-sectional study aimed to compare dietary supplements, Prophetic medicine (PM) and herbal/plants (H/P) use among adults in Saudi Arabia before and during the COVID-19 pandemic. Method: 1351 individuals participated in the study via an online survey shared on social media platforms between December 11th, 2021, and March 1st, 2022. The survey tool included 31 questions about sociodemographics, DS consumption, PM practices and H/P use, which the expert panel team validated. The data was analyzed using SPSS version 26. Descriptive statistics were presented as numbers and percentages. P-value <= 05 and 95% confidence intervals were used to report the statistical significance based on gender and prior infection with the COVID-19. Results: The most common supplements consumed before the pandemic were Vitamin D (53.4%, n=358), Multivitamins (47.3%, n=318), and Vitamin C (42%, n=282). This is along with the significant increase in the consumption of Multivitamins, Vitamin C, Vitamin B complex, Vitamin D, Zinc and Calcium during the pandemic. Females are significantly (p < 0.001) more concerned in consuming DS and H/P and practice PM before and during the COVID-19 pandemic, compared to males. Prior Covid-19 infection significantly impacted individuals' perception about DS, H/P and PM uses and practices, information and beliefs in their role in preventing and controlling the disease (p<0.05). Significant changes in weight status during the pandemic were reported. Conclusion: There was a significant increase in consumption of most dietary supplements and Prophetic medicine practices. The government should launch public awareness campaigns and employ regulations to educate about the risks and benefits of self-medicated Prophetic medicine practices and self-prescribed dietary supplements.
ABSTRACT
OBJECTIVES: Considering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS. TRIAL DESIGN: The study is a randomized, placebo-controlled, adaptive clinical trial with parallel group design, superiority framework with an allocation ratio of 1:1 among experimental (HNS) and placebo group. An interim analysis will be done when half of the patients have been recruited to evaluate the need to adapt sample size, efficacy, and futility of the trial. PARTICIPANTS: All asymptomatic patients with hospital or community based COVID-19 exposure will be screened if they have had 4 days exposure to a confirmed case. Non-pregnant adults with significant exposure level will be enrolled in the study High-risk exposure (<6 feet distance for >10min without face protection) Moderate exposure (<6 feet distance for >10min with face protection) Subjects with acute or chronic infection, COVID-19 vaccinated, and allergy to HNS will be excluded from the study. Recruitment will be done at Shaikh Zayed Post-Graduate Medical Institute, Ali Clinic and Doctors Lounge in Lahore (Pakistan). INTERVENTION AND COMPARATOR: In this clinical study, patients will receive either raw natural honey (0.5 g) and encapsulated organic Nigella sativa seeds (40 mg) per kg body weight per day or empty capsule with and 30 ml of 5% dextrose water as a placebo for 14 days. Both the natural products will be certified for standardization by Government College University (Botany department). Furthermore, each patient will be given standard care therapy according to version 3.0 of the COVID-19 clinical management guidelines by the Ministry of National Health Services of Pakistan. MAIN OUTCOMES: Primary outcome will be Incidence of COVID-19 cases within 14 days of randomisation. Secondary endpoints include incidence of COVID-19-related symptoms, hospitalizations, and deaths along with the severity of COVID-19-related symptoms till 14th day of randomization. RANDOMISATION: Participants will be randomized into experimental and control groups (1:1 allocation ratio) via the lottery method. There will be stratification based on high risk and moderate risk exposure. BLINDING (MASKING): Quadruple blinding will be ensured for the participants, care providers and outcome accessors. Data analysts will also be blinded to avoid conflict of interest. Site principal investigator will be responsible for ensuring masking. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 1000 participants will be enrolled in the study with 1:1 allocation. TRIAL STATUS: The final protocol version 1.4 was approved by institutional review board of Shaikh Zayed Post-Graduate Medical Complex on February 15, 2021. The trial recruitment was started on March 05, 2021, with a trial completion date of February 15, 2022. TRIAL REGISTRATION: Clinical trial was registered on February 23, 2021, www.clinicaltrials.gov with registration ID NCT04767087 . FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.