A Randomized Controlled Trial of the Efficacy of Systemic Enzymes and Probiotics in the Resolution of Post-COVID Fatigue

Rathi et al., Medicines, doi:10.3390/medicines8090047, CTRI/2021/05/033576

Aug 2021

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RCT 200 long-COVID patients in India, 100 treated with ImmunoSEB and ProbioSEB CSC3, showing improved recovery of post-COVID-19 fatigue with treatment. CTRI/2021/05/033576.

The immune effects of probiotics are strain-specific.

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risk of no recovery, 89.4% lower, RR 0.11, p < 0.001, treatment 9 of 100 (9.0%), control 85 of 100 (85.0%), NNT 1.3, day 14, fatigue.

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Rathi et al., 30 Aug 2021, Double Blind Randomized Controlled Trial, placebo-controlled, India, peer-reviewed, 3 authors, study period 12 May, 2021 - 31 May, 2021, trial CTRI/2021/05/033576.

Contact: akrathi@advancedenzymes.com (corresponding author), swati@advancedenzymes.com, drnehashah772@gmail.com.

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A Randomized Controlled Trial of the Efficacy of Systemic Enzymes and Probiotics in the Resolution of Post-COVID Fatigue

Abhijit Rathi, Swati B Jadhav, Neha A Shah

Medicines, doi:10.3390/medicines8090047

Muscle fatigue and cognitive disturbances persist in patients after recovery from acute COVID-19 disease. However, there are no specific treatments for post-COVID fatigue. Objective: To evaluate the efficacy and safety of the health supplements ImmunoSEB (systemic enzyme complex) and ProbioSEB CSC3 (probiotic complex) in patients suffering from COVID-19 induced fatigue. A randomized, multicentric, double blind, placebo-controlled trial was conducted in 200 patients with a complaint of post-COVID fatigue. The test arm (n = 100) received the oral supplements for 14 days and the control arm (n = 100) received a placebo. Treatment efficacy was compared using the Chalder Fatigue scale (CFQ-11), at various time points from days 1 to 14. The supplemental treatment resulted in resolution of fatigue in a greater percentage of subjects in the test vs. the control arm (91% vs. 15%) on day 14. Subjects in the test arm showed a significantly greater reduction in total as well as physical and mental fatigue scores at all time points vs. the control arm. The supplements were well tolerated with no adverse events reported. This study demonstrates that a 14 days supplementation of ImmunoSEB + ProbioSEB CSC3 resolves post-COVID-19 fatigue and can improve patients' functional status and quality of life.

Institutional Review Board Statement: The present clinical trial was conducted as per the ethical principles contained in the current revision of the "Declaration of Helsinki 2013", ICH harmonized guideline integrated addendum to ICH E6(R1): Guidelines for Good Clinical Practice ICH E6(R2) and following the "Ethical Guidelines for Biomedical Research on Human Subjects" issued by the Indian Council of Medical Research and all other applicable laws and regulations of the country. Informed Consent Statement: Informed written consent was obtained from all participants. No vulnerable subject participated in the study. Conflicts of Interest: A.R. and S.J. are paid employees of Advanced Enzyme Technologies, which sponsored the study and has a corporate affiliation with Specialty Enzymes and Probiotics. Specialty Enzymes and Probiotics had no role in the study design and actual conduct of the study. N.S. has no conflict of interest to report.

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