JMIR Publications

ABSTRACT

Background:

Iron deficiency anaemia (IDA) among women of reproductive age group continues to be a major public health problem. Iron folic acid (IFA) for the management of IDA remains the mainstay treatment for over last five decades, yet the uptake and adherence to the therapy remains limited. Punarnavadi Mandura (PM) and Drakshavaleha (DA), both the formulations are indicated for management of anaemia in various classical Ayurvedic texts, there remains sparse evidence on their equivalence to IFA. Thus, the proposed study is aimed at assessing the efficacy and safety of Ayurvedic formulations compared to standard of care in IDA.

Objective:

The primary objective of this study is to compare the mean hemoglobin at the end of intervention of 90 days in non-pregnant moderately anaemic (Hb:8-10.9 g/dL) women of reproductive age group (18-49 years) receiving Punarnavadi Mandura alone or Punarnavadi Mandura in combination to Drakshavaleha, or ferrous sulphate and folic acid combination.Secondary study objectives The secondary objectives of the study are: i) to compare the mean hemoglobin at the end of intervention of 90 days in non-pregnant moderately anaemic (Hb:8-10.9 g/dL) women of reproductive age group (18-49 years) receiving Punarnavadi Mandura alone with those receiving Punarnavadi Mandura in combination with Drakshavaleha; ii) to compare proportion of those with Hb > 11 g/dL at the end of the 90 days of treatment and at 180 days follow up from baseline in two intervention arms and active control arm; iii) to compare the change in other haematological parameters (haematocrit, MCV, MCH & MCHC) and Iron indices (TIBC, serum iron, transferrin saturation and serum ferritin) at 90 days of treatment and at 180 days follow up from baseline in two intervention arms and active control arm; iv) to compare the safety and adherence in two intervention arms and active control arm; v) to compare the change in quality of life using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale at the end of 90 days of treatment and 180 days follow up from baseline in two intervention arms and active control arm.

Methods:

A parallel three arm, open labeled, multi-centre randomized controlled equivalence trial will be conducted with the primary objective to compare the mean hemoglobin at the end of intervention of 90 days in non-pregnant moderately anaemic (Hb:8-10.9 g/dL) women of reproductive age group (18-49 years) receiving PM alone or PM in combination to DA, or ferrous sulphate and folic acid combination. The study is being conducted in eight sites across India with intervention period of 90 days and follow up of another 90 days. The secondary objectives are to find the proportion of participants with Hb > 11 g/dl, change in other hematological parameters (hematocrit, MCV, MCH & MCHC) and Iron indices (TIBC, serum iron, transferrin saturation and serum ferritin), safety and adherence and change in quality of life at 90 days of treatment and at 180 days follow up from baseline.

Results:

Enrollment of the study participants commenced on 30th July 2024. All the participants have been enrolled and follow up of the participants is ongoing. The study is likely to be completed by 31st March, 2026.

Conclusions:

This multi centric trial is one of the first randomized controlled trial aimed at evaluating the efficacy of Ayurvedic medicines in the treatment of IDA in comparison to the current mainstay treatment, thereby generating an evidence base for traditional systems of medicine in the management of IDA. It will evaluate the efficacy and safety of ayurvedic formulations in different population groups across different geographic regions of the country, which will be critical to formulate guidelines for the management of IDA keeping evidence from varied geographic settings. It will also contribute towards improved quality of life of population with IDA. Clinical Trial: Clinical Trial Registry of India (https://ctri.nic.in), CTRI/2023/11/060271 dated 28th November 2023