A prospective, open-label, randomized, active control, parallel-group trial on the efficacy of Darvyadi Leha in iron deficiency anemia of children: Study protocol of a randomized controlled trial

BACKGROUND: Iron deficiency anemia (IDA) is a major health problem among children in India. Due to the adverse effects of oral iron supplementation, there is a need to find an alternative therapeutic option for IDA, which is safe, tolerable, with comparable efficacy. OBJECTIVE: This clinical study is designed to determine the efficacy and safety of Darvyadi Leha in IDA of children compared with ferrous ascorbate. MATERIALS AND METHODS: This prospective, open-label, randomized, active control, parallel-group trial will be conducted at Uttarakhand Ayurved University, Gurukul Campus, Haridwar. A total of 76 participants will be enrolled in the study. Patients of any gender aged 3–12 years with IDA, having hemoglobin 7.5–11 g/dL and serum ferritin less than 15 mcg/dL will be considered for enrollment in the study. The enrolled participants will be given a tablet of Albendazole 400-mg single dose for deworming. Thereafter, they will be randomly divided into two groups. Patients of Group A will be administered Darvyadi Leha 4, 7, 9, and 12 g/day in two equally divided doses for age groups 3–5, 5–8, 8–10, and 10–12 years, respectively, for 90 days. Patients of group B will be administered ferrous ascorbate 4 mg/kg/day twice daily for 90 days. The outcome measures are changes in hemoglobin level, ferritin level, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, and reticulocyte count. Patients will also be assessed for graded subjective parameters on each visit. Safety will be assessed based on the incidence of adverse events, and changes in liver and kidney function tests. DISCUSSION: Ayurveda formulations have been used for the management of anemia in routine clinical practice for adults. Further, several research studies have also been conducted regarding the same. However, the use of Ayurveda interventions in anemia of children is less common, and a few randomized controlled studies on anemia of children have been conducted. So, it is expected that the outcomes of this trial will suggest probable therapeutic options for the effective management of IDA of children. TRIAL REGISTRATION: CTRI/2022/07/044074