Efficacy and safety of integrative therapy of Drakshavaleha with oral iron folic acid supplements in management of mild to moderate iron deficiency anaemia in women of reproductive age group- A protocol for a parallel group randomized controlled trial

IF 2.1 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE

Journal of Ayurveda and Integrative Medicine Pub Date : 2026-05-01 Epub Date: 2026-05-22 DOI:10.1016/j.jaim.2026.101352

Manish J. Barvaliya , Kalesh M. Karun , M.S. Chandrashekar , N. Chandan , Harsha V. Hegde , Sandeep S. Sagare , Ravikumar BS , Subarna Roy

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引用次数: 0

Abstract

Background

Adding Drakshavaleha to iron-folic acid (IFA) supplementation could lead to a significant increase in hemoglobin (Hb) levels compared to IFA alone due to its bioavailability-enhancing property. This paper presents a protocol for the randomized controlled trial (RCT) assessing the efficacy and safety of integrating Drakshavaleha with IFA supplementation in improving hemoglobin levels among women aged 18-49 years with mild to moderate iron-deficiency anaemia.

Methods

This parallel-group, open-label, community-based randomized controlled trial will include women aged 18 to 49 years with mild (Hb 11-11.9 g/dL) to moderate (Hb 8-10.9 g/dL) iron deficiency anaemia. Consecutive participants meeting the inclusion/exclusion criteria will be enrolled after providing written informed consent and randomly assigned to one of two groups in a 1:1 ratio using block randomization. The control group will receive 200 mg of ferrous sulphate and 0.5 mg of folic acid orally, twice daily after food for 3 months. The intervention group will receive 6 g of Drakshavaleha orally, twice daily before food, in addition to the same IFA dosage as the control group. Participants will be followed up monthly at 1, 2 and 3 months. At all follow-up visits, CBC and iron profiles will be done whereas serum creatinine, serum bilirubin, serum glutamic pyruvic aminotransferase (SGPT), and HbA1C will be done at 3 months.

Conclusion

This protocol outlines the RCT to assess the efficacy and safety of integrating Drakshavaleha with IFA supplements and explore Drakshavaleha's role in enhancing assimilation of oral iron from supplements and nutrition.

Trial registration number

The trial is registered in Clinical Trials Registry - India (CTRI) under registration number CTRI/2024/05/067169.

查看原文本刊更多论文

Drakshavaleha联合口服叶酸铁补充剂治疗育龄妇女轻度至中度缺铁性贫血的疗效和安全性——一项平行组随机对照试验方案

背景：与单独添加铁叶酸（IFA）相比，将Drakshavaleha添加到铁叶酸（IFA）补充剂中可以显著增加血红蛋白（Hb）水平，这是由于其提高生物利用度的特性。本文提出了一项随机对照试验（RCT）方案，评估Drakshavaleha联合IFA补充剂改善18-49岁轻度至中度缺铁性贫血女性血红蛋白水平的有效性和安全性。方法：这项平行组、开放标签、社区为基础的随机对照试验将纳入年龄在18至49岁、患有轻度（血红蛋白11-11.9 g/dL）至中度（血红蛋白8-10.9 g/dL）缺铁性贫血的女性。符合纳入/排除标准的连续受试者将在提供书面知情同意后入组，并使用块随机法以1:1的比例随机分配到两组中的一组。对照组在进食后口服200毫克硫酸亚铁和0.5毫克叶酸，每天两次，持续3个月。干预组在与对照组相同的IFA剂量的基础上，在餐前口服6g Drakshavaleha，每日两次。参与者将在1、2和3个月进行每月随访。在所有随访中，将进行CBC和铁谱检查，而血清肌酐、血清胆红素、血清谷丙转氨酶（SGPT）和HbA1C将在3个月时进行检查。本方案概述了一项随机对照试验，以评估将Drakshavaleha与IFA补充剂联合使用的有效性和安全性，并探讨Drakshavaleha在促进补充剂和营养中口服铁的吸收方面的作用。该试验已在印度临床试验注册中心（CTRI）注册，注册号为CTRI/2024/05/067169。

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