Efficacy and safety of Siddha regimen for management of mild to moderate iron deficiency anaemia amongst reproductive age-group women as compared to iron folic acid supplements: A protocol for an open labelled, multicentric randomized equivalence trial.

BACKGROUND

Iron deficiency anaemia is the most prevalent dietary deficiency anaemia, affecting 30% of the global population. According to WHO (2019), anaemia affects 500 million women (15-49 years) globally. In India, 57.2% of women in this age group are anaemic despite the "Anaemia Mukt Bharat Programme". The main challenge with standard iron and folic acid therapy is poor compliance due to forgetfulness and gastrointestinal side effects, necessitating alternative treatments like Siddha medicines with better efficacy and tolerability.

OBJECTIVE

The primary objective is to compare the efficacy of Siddha regimen versus standard care in improving haemoglobin levels among women (18-49 years) with mild to moderate iron deficiency anaemia. Secondary objectives include evaluating changes in red cell indices, iron profile parameters, adverse reaction frequency, and documenting mukkutram status using naadi assessment.

MATERIALS AND

METHODS

A randomized, controlled, open-labelled, multicentre equivalence clinical trial with two arms and 1:1 allocation is designed to enroll 170 participants. Women aged 18-49 years with mild to moderate anaemia and serum ferritin <30mcg/dL will be included after informed consent. Participants will receive either iron and folic acid supplements or Siddha regimen as per group allocation.

OUTCOME MEASURES: Primary outcome is the change in haemoglobin at the end of 3rd month. Secondary outcomes include changes in serum iron, Total iron binding capacity, ferritin, transferrin saturation, red blood cell indices, and correlation of mukkutram types with haemoglobin improvement.

TRIAL STATUS: The study is registered with Clinical Trial Registry of India (CTRI/2025/01/079620) and will commence post-funding release.