治疗孕妇贫血的阿育吠陀制剂 "Sangfer "的临床评估:一项开放标签临床研究

Dr SUSHMA KR, Dr BG VARUNI
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引用次数: 0

摘要

背景:孕期缺铁是导致婴幼儿贫血的主要原因之一。缺铁会对整个孕期的孕产妇和胎儿健康产生负面影响,更有可能对孕产妇和胎儿造成不良后果。孕产妇补铁是解决全球缺铁问题和预防其不良后果的重要手段。研究方法进行了一项开放标签非比较性前瞻性临床试验,以评估 "Sangfer "液体对 16 名贫血孕妇的疗效。"Sangfer "是一种多草药阿育吠陀中成药,含有铁元素和锌元素,以及四种药材,即睡茄、甘草、天门冬和葛根。研究的目的是检测其治疗孕妇贫血的有效性和安全性。给药剂量为 10 毫升,每天两次,饭后服用,持续 12 周(84 天)。患者在筛查(第 1 次检查,第 0 天)、基线(第 2 次检查,第 1 天)和随访(第 3 次检查,第 28 天;第 4 次检查,第 56 天;第 5 次检查,第 84 天)时接受评估。结果平均血红蛋白水平明显增加,从第 1 天的 8.08% 增加到第 84 天最后一次就诊时的 11.19%。贫血体征和症状评分也从第 1 天到不同随访期间明显降低。医生总体评估(PGA)平均评分从第 1 天的 1.0 降至最后随访时的 0.0。结论"Sangfer "对治疗孕期贫血非常有效。研究期间未发现任何不良反应,包括严重不良反应。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical Evaluation of an Ayurvedic Preparation “Sangfer” for the Treatment of Anemia in Pregnant Women: An Open-labeled Clinical Study
Background: Iron deficiency during pregnancy is one of the primary causes of anemia in infants and young children. Ithas a negative impact on maternal and fetal health throughout pregnancy with higher likelihood of adverse maternal andfetal outcomes. Maternal iron supplementation is a critical tool to address the global problem of iron deficiency and preventits negative consequences. Method: An open-label non-comparative prospective clinical trial was carried out to evaluatethe effectiveness of “Sangfer” liquid in 16 pregnant women with anemia. “Sangfer” is a polyherbal Ayurvedic proprietarymedication containing elemental iron and zinc and four medicinal herbs viz. Withania somnifera, Emblica officinalis, Asparagusracemosus and Pueraria tuberosa. The aim of the study was to examine its efficacy and safety in treating anemia in pregnantwomen. The dose administered was 10 mL twice daily after food for 12 weeks (84 days). Patients were evaluated at screening(Visit 1 at Day 0), baseline (Visit 2 at Day 1) and during follow-ups (Visit 3 at Day 28, Visit 4 at Day 56 and Visit 5 atDay 84). Results: There was a significant increase in mean hemoglobin levels from 8.08% at Day 1 to 11.19% at the finalvisit at Day 84. The anemia sign and symptom scores also significantly reduced from Day 1 to different follow-up visits.The mean Physician Global Assessment (PGA) score was found to reduce from 1.0 at Day 1 to 0.0 at the final follow-upvisit. Conclusion: “Sangfer” is highly effective for the treatment of anemia during pregnancy. No adverse effects includingserious adverse effects were observed during the study period.
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