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.

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.