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: An open labelled, multicentric randomized controlled trial

Anemia/Paandu is one of the important illnesses, which cause a severe disease burden among Indians. The World Health Organization (WHO) has estimated that globally, 1.62 billion people are anemic and it was especially prevalent among rural areas of India. According to WHO global statistics, 40% of pregnant women, and 42% of children under the age of five are anaemic. It alters immune mechanisms and also associated with increased morbidity rates. The economic and social growth of a nation is impacted by anaemia, as it is attributed to delayed cognitive and motor development in children and reduced work capacity in adults (WHO, 2022).The WHO has recognised iron deficiency anaemia (IDA) as the most common nutritional deficiency in the world, with 30% of the population being affected with this condition. Although the most common causes of IDA are gastrointestinal bleeding and menstruation in women, decreased dietary iron and decreased iron absorption are also culpable causes. Patients with IDA should be treated with the aim of replenishing iron stores and returning the haemoglobin to a normal level.

In India, seven out of every 10 children from 6 to 59 months are anaemic. Anemia is a major public health concern in India. According to National Health Family Survey 5 (2019-21), 57.2% women of reproductive age group (15 to 49 years) suffer from anemia in India . To reduce the burden of anemia in the country, the Government of India launched Anemia Mukt Bharat Programme in 2018 with the objective of reducing the prevalence of anemia by 3 percentage points per year among children, adolescents, and women in the reproductive age group (15–49 years), between the year 2018 and 2022 . A targeted prevalence reduction of anemia in women of the reproductive age group was set from 57% (2016) to 35% (2022) under this programme [4]. However, the prevalence of anemia has been found to be almost the same. The major issue with IFA supplements is poor compliance due to forgetfulness and intolerable GI side effects Iron deficiency and iron load both can cause oxidative stress which in turn causes intestinal mucosal damage due to inflammation. Thus, iron absorption is affected in most of the anaemic patients which may reduce the effect of oral iron supplements and may cause gastrointestinal problems . The addition of Vitamin C to IFA is helpful in enhancing the absorption of iron by keeping it in a reduced ferrous form. However, it does not address the issue of gastrointestinal side effects. Although the conventional treatment for iron deficiency anaemia involves taking iron supplements like ferrous sulphate or elemental iron, adherence to the medicine is challenging due to variety of adverse side effects like metallic taste, epigastric discomfort, nausea, diarrhoea, constipation, etc. The adverse effects of iron supplements can be reduced by taking medications with food. However, doing so might decrease the absorption of iron. Therefore, there is a need to search for innovative drugs that have better therapeutic value and lesser side effects (Nguyen and Tadi, 2022).

In Siddha system of medicine anaemia condition may be compared with the word Paandu literally means pallor. In this clinicalcondition the conjunctiva, tongue, nail bed turns into pallor and it is having been named as Paandu Noi. Syn:Velluppu Noi, Venmai Noi. There are many herbo mineral medicines which are found effective in alleviating iron deficiency anaemia which contains Punica granata, Vitis vinifera, Nigella Sativa, Smilax china, processed elemental iron. This study  aims to compare the efficacy of Siddha regimen containing traditional oleation by medicated oil Arakkuthylam[9], deworming by NaakkupoochiKudineer followed byBavana Kadukkai ,Aya BhringarajaPaanitham, constituted for anaemia with Standard of Care. Likewise Aya bhringarajaPaanitham contains iron in its elemental iron in combination with herbal medicines which is indicated for Paandu Noi as per Siddha literature, this is also an effective haematinic which can be used as first line of treatment for anaemia even in pediatric population, this drug has undergone repeated dose 28 day oral toxicity studies and revealed no observed adverse effect level (NOAEL) in animals as per Vijaya Kumar et al. Thus the safety of the drug in human usage was ensured.

Need foratrial

Despite of wide promotion of IFA amongst beneficiaries, the burden of anemia remains the same which suggests the need for additional measures to improve nutrition, compliance, and/or additional use of alternative systems of medicine that can address the issue of assimilation of iron and its GI side effects.