An Open Label, Randomized Control Proof of Concept Study to Compare the Effectiveness of Thiriloga Chendhuram (TC) with Annabedhi Chendhuram (ABC; Active Control) in the Treatment of Veluppu Noi (Iron Deficiency Anemia) in Women of Reproductive Age: A Prospective Double-Arm Clinical Trial Protocol.

BACKGROUND

Iron deficiency anemia (IDA) constitutes a worldwide health issue, particularly affecting women of reproductive age. Conventional treatments have limitations and side effects, prompting the exploration of alternative therapies. Siddha system of medicine offers potential remedies with minimal side effects. This trial aims to assess the safety and effectiveness of Thiriloga Chendhuram (TC), a herbometallic preparation from Siddha medicine, in the correction of IDA. The study also seeks to understand TC's potential mechanisms of action through comprehensive hematological and biochemical investigations.

MATERIALS AND

METHODS

This is an open-labeled randomized controlled proof-of-concept study with an active control. From SRRI, Puducherry OPD who meet the inclusion criteria are enrolled for this trial. The study site is Siddha Regional Research Institute, Puducherry. Trial participants are randomly assigned to two groups to receive either TC or Annabedhi Chendhuram (ABC-Active Control) at a 1:1 ratio. All the quantitative outcomes will be analyzed using SPSS software.

RESULTS

This study is expected to be completed in approximately 12 months, based on recruitment. The results of the study will be published in a peer-reviewed journal.

CONCLUSION

This proof-of-concept study addresses the challenges of IDA in women of reproductive age, emphasizing the potential role of Siddha medicine and offering alternatives for managing IDA. This trial also assesses the reticulocyte hemoglobin content (CHr) and percentage of hypochromic cells (% hypo), which offer enhanced sensitivity, specificity, and reliability for diagnosing IDA. The findings will pave the way for future large-scale trials and also contribute to innovative approaches in addressing IDA.