Srikanth Narayanam, Rao Bhogavalli Chandrasekhara, Yadav Babita, Rai Amit Kumar, Jameela Sophia, Rana Rakesh Kumar, Singhal Richa, Khanduri Shruti, Sharma Bhagwan Sahai, Makhija Pratap
Deputy Director General, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Government of India.
Department of Ayurveda, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Government of India.
Ayu. 2021 Apr-Jun;42(2):69-75. doi: 10.4103/ayu.ayu_379_21. Epub 2023 Mar 16.
The burden of iron-deficiency anemia (IDA) remains persistently high in India due to the poor tolerability of oral iron supplementation. Therefore, more focus is required to explore traditional medicine for safe and effective options for managing IDA.
To assess the clinical safety and efficacy of in patients with IDA.
An open-label, prospective, single-arm, multi-center trial was conducted at 12 centers with a sample size of 40 participants per study site. Patients with IDA aged 18-60 years with hemoglobin levels in the range of 6-10gm/dl, mean corpuscular volume (MCV) <80 fl, mean corpuscular hemoglobin concentration (MCHC) <34 μg/dl, serum ferritin <30 μg/dl and serum iron <50 μg/dl were included in the study. 500 mg capsule was administered twice daily with lukewarm water after meals for 45 days. The primary outcome measure was the change in hemoglobin (Hb%) level from baseline to day 45. Secondary outcome measures included the change in MCV, MCHC, serum iron and ferritin levels, incidence of adverse events, and change in safety parameters (liver and kidney function tests). The mean (statistical) change in outcome measures from baseline to day 45 was compared using a paired sample t-test.
Out of 458 participants enrolled in the study, 400 contributed to the final analysis. A significant difference was observed in the outcome parameters such as Hb%, MCV, MCHC, serum ferritin, and serum iron levels ( < 0.001) after 45 days of treatment. Mean Hb% changed from 8.46 ± 1.14 g/dl at baseline to 9.18 ± 1.61 g/dl on day 45 ( < 0.001). LFT and KFT were within the normal limits after the study period. No participant withdrew from the study due to adverse events.
is a safe intervention and can be expected to improve hemoglobin levels, red blood cell parameters, and iron stores in patients with IDA. Future RCTs with a larger sample size, standard care as control and a longer follow-up may produce more accurate and reliable results.
由于口服铁补充剂耐受性差，缺铁性贫血（IDA）在印度的负担一直居高不下。因此，需要更多关注探索传统医学中管理IDA的安全有效方法。
评估[具体药物名称未给出]对IDA患者的临床安全性和疗效。
在12个中心进行了一项开放标签、前瞻性、单臂、多中心试验，每个研究地点样本量为40名参与者。纳入年龄在18 - 60岁、血红蛋白水平在6 - 10gm/dl范围内、平均红细胞体积（MCV）<80 fl、平均红细胞血红蛋白浓度（MCHC）<34 μg/dl、血清铁蛋白<30 μg/dl且血清铁<50 μg/dl的IDA患者。[具体药物名称未给出]500毫克胶囊餐后用温水每日服用两次，共45天。主要结局指标是从基线到第45天血红蛋白（Hb%）水平的变化。次要结局指标包括MCV、MCHC、血清铁和铁蛋白水平的变化、不良事件发生率以及安全参数（肝功能和肾功能检查）的变化。使用配对样本t检验比较从基线到第45天结局指标的平均（统计学）变化。
在纳入研究的458名参与者中，400名参与了最终分析。治疗45天后，在Hb%、MCV、MCHC、血清铁蛋白和血清铁水平等结局参数方面观察到显著差异（P<0.001）。平均Hb%从基线时的8.46±1.14 g/dl变化到第45天的9.18±1.61 g/dl（P<0.001）。研究期后肝功能和肾功能检查在正常范围内。没有参与者因不良事件退出研究。
[具体药物名称未给出]是一种安全的干预措施，有望改善IDA患者的血红蛋白水平、红细胞参数和铁储备。未来样本量更大、以标准治疗作为对照且随访时间更长的随机对照试验可能会产生更准确可靠的结果。
