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.
4 affiliations
- 1National Institute of Siddha, Tambaram Sanatorium, Chennai, Tamil Nadu, 600047, India. Electronic address: [email protected].
- 2ICMR-National Institute of Traditional Medicine, Nehru Nagar, Belagavi, Karnataka, 590010, India.
- 3National Institute of Siddha, Tambaram Sanatorium, Chennai, Tamil Nadu, 600047, India.
- 4ICMR-National Institute of Traditional Medicine, Nehru Nagar, Belagavi, Karnataka, 590010, India. Electronic address: [email protected].
Abstract
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.
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BibTeX
@article{shanmugapriya2026efficacy,
title = {{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.}},
author = {P Shanmugapriya and T Subathra and R Gayatri and N Chandan and Manish J Barvaliya and M Ramamurthy and I Sangeetha and Kalesh M Karun and G Senthilvel and Subarna Roy},
journal = {Journal of Ayurveda and integrative medicine},
year = {2026},
month = sep,
doi = {10.1016/j.jaim.2026.101399},
url = {https://europepmc.org/article/MED/42879886},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - 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.
AU - P Shanmugapriya
AU - T Subathra
AU - R Gayatri
AU - N Chandan
AU - Manish J Barvaliya
AU - M Ramamurthy
AU - I Sangeetha
AU - Kalesh M Karun
AU - G Senthilvel
AU - Subarna Roy
PY - 2026
DA - 2026/09/01
JO - Journal of Ayurveda and integrative medicine
DO - 10.1016/j.jaim.2026.101399
UR - https://europepmc.org/article/MED/42879886
AB - 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.
SN - 0975-9476
SN - 0976-2809
ER -