Written by Taylor Woosley, Staff Writer. Results of the multi-center, randomized, double-blind, placebo-controlled trial shows that use of Aviron Rapid significantly reduced disease duration and symptom severity compared to placebo in both adolescent and pediatric cohorts.
Acute upper respiratory infections (AURTIs), which include the common cold, acute sinusitis, and acute pharyngitis, are a major cause of morbidity, especially in children and the elderly1. An AURTI, caused by a variety of viruses and bacteria, usually involves direct invasion of the upper airway mucosa by the organism2. The risk of antibiotic use for AURTIs often outweighs the possible benefit, yet antibiotics are often prescribed and account for 44% of all outpatient antibiotic prescriptions3.
Herbal products have long been used in place of antibiotics due to their strong antiviral and antimicrobial properties4. Andrographolide is a labdane diterpene and the main ingredient of Andrographis paniculate that possesses diverse biological effects including anti-inflammatory and antioxidant properties5. Humic acids include a variety of pigmented organic molecules primarily distributed in soils that have been associated with anti-viral activities6. Furthermore, spirulina is an algae-based nutraceutical shown to exert antiviral effects through boosting the adaptive and innate immune system7.
Markova et al. conducted a multi-center, randomized, double-blind, placebo-controlled trial to assess the efficacy of Aviron Rapid, a dietary supplement containing andrographolide, proprietary spirulina, and humic acid, in subjects experiencing a clinically diagnosed viral AURTI. Subjects were recruited from 85 general practitioner practices and included 3 age cohorts: adults (18-60 years), adolescents (13-17 years), and children (5-12 years). Participants in the children (n = 319) and adolescent (n = 329) groups were included in the final analysis and randomized to either Group 1 (receiving standard symptomatic therapy and Aviron Rapid) or Group 2 (receiving standard symptomatic therapy and a placebo). Aviron Rapid was available as 647 mg tablets containing 10 mg andrographolide, 100 mg proprietary spirulina extract, and 250 mg proprietary humic acid racemic mixture. Adolescents supplemented 3 tablets 3 times daily on day 1, 2 tablets 3 times daily on day 2, and 1 tablet 3 times daily on days 3 to 5. Children consumed 2 tablets 3 times daily on day 1 and 1 tablet 3 times daily on days 2 to 7. Standard symptomatic therapy included non-steroidal anti-inflammatory drugs, decongestants, mucolytics, and antitussives.
Participants and their parents were instructed on day 1 of the trial to record axillary temperature, antipyretics intake, symptom severity, and recovery status twice daily in 12-hour intervals during the treatment period. A closing visit was conducted at the end of treatment on day 6 for adolescents and day 8 for children. At the visit, the general practitioner measured axillary temperature, followed by a clinical examination of the subject to assess the subject’s condition, and then verified the completion of the recorded data. Primary outcomes of the study were the number of clinically recovered patients and mean disease duration. Participants were deemed clinically recovered if they experienced persistent symptom improvement and steady axillary temperature decrease without the use of antipyretics.
In the adolescent group, 172 subjects completed the Aviron Rapid treatment, and 157 participants completed the placebo. In the children group, 161 subjects finished the Aviron Rapid treatment, and 158 participants received the placebo. The 2-proportion Z-test was utilized to compare the percentages of clinically recovered subjects between the Aviron Rapid and placebo group. An independent t-test was used to compare the mean disease duration in both groups. Significant findings of the study are as follows:
- Regarding the adolescent cohort, subjects in the Aviron Rapid group had consistently higher percentages of patients meeting the criteria for clinical recovery compared to placebo from 24 hours after the first treatment (p = 0.0055) until the end of treatment (p = 0.0052). The treatment group experienced a significantly lower mean disease duration compared to placebo (p = 0.003).
- Regarding the pediatric cohort, the treatment group had a significantly higher percentage of clinically recovered subjects compared to placebo from 24 hours after initial treatment (p = 0.31) until the end of treatment (p = 0.001). The treatment group had a significantly lower disease duration compared to placebo (p = 0.003).
- In both cohorts, the treatment groups experienced a significantly lower mean time to persistent decrease of temperature compared to placebo (in adolescents p = 0.005, in children p = 0.001).
Results of the study show that use of Aviron Rapid in combination with standard symptomatic therapy for treatment of AURTIs significantly improved the mean total severity of symptoms and clinical recovery compared to placebo. Further research should continue to explore the use of herbs and nutraceuticals for viral infections.
Source: Markova, Rada M., Iren S. Tzotcheva, Penka Perenovska, Atanas Mangarov, Lubomira Nikolaeva-Glomb, and Veselin Hadjiev. “Efficacy and safety of Aviron Rapid® in adolescents and children with viral acute upper respiratory tract infection: a multi-center, randomized, double blind, placebo-controlled clinical trial.” Folia Medica 65, no. 4 (2023): 546-568.
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Posted October 16, 2023.
Taylor Woosley studied biology at Purdue University before becoming a 2016 graduate of Columbia College Chicago with a major in Writing. She currently resides in Glen Ellyn, IL.
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- Ratha SK, Renuka N, Rawat I, Bux F. Prospective options of algae-derived nutraceuticals as supplements to combat COVID-19 and human coronavirus diseases. Nutrition. Mar 2021;83:111089. doi:10.1016/j.nut.2020.111089