ORIGINAL ARTICLE
Year : 2021 | Volume
: 42 | Issue : 2 | Page : 69--75
Dhatri Lauha in the management of iron deficiency anemia: A prospective open-label single-arm multi-center trial
Narayanam Srikanth1, Bhogavalli Chandrasekhara Rao2, Babita Yadav2, Amit Kumar Rai2, Sophia Jameela2, Rakesh Kumar Rana3, Richa Singhal3, Shruti Khanduri2, Bhagwan Sahai Sharma2, Pratap Makhija2
1 Deputy Director General, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Government of, India
2 Department of Ayurveda, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Government of, India
3 Department of Biostatistics, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Government of, India
Correspondence Address:
Amit Kumar Rai
Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Government of India, 61-65, Institutional Area, Opposite D-Block, Janak Puri, New Delhi - 110 058
India
Background: 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. Aim: To assess the clinical safety and efficacy of Dhatri Lauha in patients with IDA. Materials and methods: 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. Dhatri Lauha 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. Results: 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 (P < 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 (P < 0.001). LFT and KFT were within the normal limits after the study period. No participant withdrew from the study due to adverse events. Conclusions:Dhatri Lauha 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.
How to cite this article:
Srikanth N, Rao BC, Yadav B, Rai AK, Jameela S, Rana RK, Singhal R, Khanduri S, Sharma BS, Makhija P. Dhatri Lauha in the management of iron deficiency anemia: A prospective open-label single-arm multi-center trial.AYU 2021;42:69-75
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How to cite this URL:
Srikanth N, Rao BC, Yadav B, Rai AK, Jameela S, Rana RK, Singhal R, Khanduri S, Sharma BS, Makhija P. Dhatri Lauha in the management of iron deficiency anemia: A prospective open-label single-arm multi-center trial. AYU [serial online] 2021 [cited 2023 Mar 24 ];42:69-75
Available from: https://www.ayujournal.org/article.asp?issn=0974-8520;year=2021;volume=42;issue=2;spage=69;epage=75;aulast=Srikanth;type=0 |
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