A clinical study evaluating low dose ferrous fumarate vs. standard iron supplements in iron-deficient non-anemic to mild anemic adults.

Our study aims to validate safety and efficacy of Feroglobin capsule compared with different iron supplementations in adult subjects diagnosed with non-anemic to mild anemic iron deficiency and fatigue. Enrolled 302 participants diagnosed with non-anemic to mild anemic iron deficiency and fatigue. Group A (n = 147) received Feroglobin, Group B (n = 146) received standard of care [Haem Up Gems capsules (Ferrous fumarate) or Fericip tablets (Ferrous ascorbate)]. 293 subjects completed the study with follow-up visits on days 30, 60, and 90. Feroglobin treatment significantly increased hemoglobin levels from mean 12.43 g/dl to 13.24 g/dl in 90 days. Ferritin levels improved significantly by 442.87% compared to the standard care's 256.67%. Fatigue scale scores reduced by 47.51%, and all presenting health complaints resolved completely. Gastrointestinal symptoms observed were similar in both the groups. Both groups exhibited moderate treatment adherence. Quality of life improved in pain and general health domains, exhibiting a good tolerability. Adverse events were unrelated to the investigational products. Feroglobin serves as an efficacious therapeutic alternative for improving hemoglobin, ferritin, and reducing fatigue with low doses compared to standard of care. However, longer-term effects of low-dose require further investigations in different target groups.

Impact of antioxidants in improving semen parameters like count, motility and DNA fragmentation in sub-fertile males: a randomized, double-blind, placebo-controlled clinical trial.

Male infertility is solely responsible for 20-30% of infertility cases. Oxidative damage of sperm DNA is positively linked with oligoasthenoteratozoospermia (OAT), and male infertility. The antioxidants are being explored worldwide to combat OAT, sperm DNA fragmentation and reactive oxygen species. The objective of the study was to assess the effectiveness of an antioxidant blend in improving sperm count, semen parameters and reducing DNA fragmentation index (DFI) in sub-fertile males. A prospective, double-blind, randomized, placebo-controlled trial was conducted in 300 sub-fertile males (25-45 years) from ten study sites in India. Subjects were randomized in either the antioxidant blend treatment group or placebo group. We assessed changes in sperm count, motility, normal morphology, semen volume, and percent DFI before and after treatment (90 days). To further stratify data on different criteria post hoc analysis was performed. Statistical analysis was performed using SPSS 10.0 software. There were improvements in sperm count, semen volume, sperm motility, and sperm normal morphology in the treatment group. There was improvement in sperm count in severe oligospermia subjects (sperm count < 5 million/mL, 5-10 million/mL, 10.1-15 million/mL), and high-extremely higher baseline DFI (20-30%, 31-40% and above 40%), as per post hoc analysis. There was no premature discontinuation and adverse events were reported during the study, indicating safety and well-tolerability of treatment. Study results confirmed the well-researched fact of antioxidants being effective to reduce oxidative stress and thus improve sperm DNA integrity and also improved semen parameters in males aged 40 and above. Trial Registration: Clinical Trials Registry-India Identifier: CTRI/2020/12/029590.

Efficacy and Safety of Aspirin, Promethazine, and Micronutrients for Rapid Clinical Recovery in Mild to Moderate COVID-19 Patients: A Randomized Controlled Clinical Trial.

Introduction In the present study, the combination of two tablets, one with Aspirin and Promethazine and the other with vitamin D3, C, and B3 along with zinc and selenium supplementation was proposed as an intervention (APMV2020). The ingredients in the formulation represent a precise, tailored therapy for the symptoms of COVID-19, combined with natural constituents to help the body itself build immunity to recover from infection. The present study was conducted to clinically validate the safety and efficacy of the APMV2020 tablets. Trial design The present trial is a randomized, multicentric, controlled clinical trial involving 260 mild to moderate COVID-19 patients. The treatment duration was of 10 days. Methodology The subjects were randomized to receive either the control intervention (clinical management protocol for COVID-19 advocated by the Indian Council of Medical Research (ICMR) or the test intervention (treatment with APMV2020 tablets along with the standard control treatment. The assessment days were baseline, days five and 10. Results APMV2020 significantly (<0.05) improved symptoms of COVID-19 like cough, myalgia, headache, and anosmia as compared to the control group. APMV2020 treatment also reduced inflammatory markers like lactate dehydrogenase (LDH), ferritin, and C-reactive protein (CRP). Conclusion APMV2020 can prove as a good candidate to be integrated into the COVID-19 management protocol. As it can offer speedy clinical recovery to reduce the burden on healthcare infrastructure, second, the combination shows significant anti-inflammatory potential to improve prognosis, and lastly, the immunomodulatory properties offer long-term protection that can help in combating long COVID symptoms and complications.

Correction: Efficacy and Safety of Aspirin, Promethazine, and Micronutrients for Rapid Clinical Recovery in Mild to Moderate COVID-19 Patients: A Randomized Controlled Clinical Trial.

[This corrects the article DOI: 10.7759/cureus.25467.].